search
Back to results

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab (K)
Placebo (P)
Paclitaxel (X)
Doxorubicin (A)
Epirubicin (E)
Cyclophosphamide (C)
Endocrine therapy
Radiation therapy
Surgery
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring PD1, PD-1, PDL1, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed.
  • Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.
  • Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status.

Note: Sponsor agreement is required for formalin-fixed paraffin-embedded (FFPE) tumor tissue sample or slides that were obtained greater than 60 days prior to the date that the documented informed consent was obtained.

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment.
  • Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.
  • Female participants must agree to use effective contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo.
  • Has adequate organ function.

Exclusion Criteria:

  • Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis.
  • Has breast cancer with lobular histology.
  • Has bilateral invasive breast cancer.
  • Has metastatic (Stage IV) breast cancer.
  • Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
  • Has any of the following clinical lymph node staging per current American Joint Committee on Cancer (AJCC) staging criteria for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c.
  • Has ER-, progesterone receptor positive breast cancer.
  • Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or has undergone sentinel lymph node biopsy prior to study treatment.
  • Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years.

Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Has a known history of active tuberculosis (Bacillus tuberculosis).
  • Has an active infection requiring systemic therapy.
  • Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
  • Has other significant cardiac disease, such as: 1) History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months. or 2) Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of hepatitis B or known active hepatitis C virus infection.
  • Has received prior treatment for breast cancer.
  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137).
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
  • Has severe hypersensitivity (≥Grade 3) to any of the components or excipients used in the study treatments.
  • Is/was enrolled in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks (12 months for an investigational agent or device with anticancer or antiproliferative properties) prior to the first dose of study treatment.
  • Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment.

Sites / Locations

  • Southern Cancer Center, PC ( Site 8003)
  • Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)
  • Arizona Oncology Associates PC- HOPE ( Site 8008)
  • Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)
  • El Camino Hospital Cancer Center ( Site 0004)
  • Stanford Cancer Center ( Site 0072)
  • UC Davis Comprehensive Cancer Center ( Site 0073)
  • University of Colorado Cancer Center ( Site 0008)
  • Baptist MD Anderson Cancer Center ( Site 0014)
  • Southeastern Regional Medical Center, Inc. ( Site 0075)
  • The University of Chicago Medical Center ( Site 0080)
  • Orchard Healthcare Research Inc. ( Site 0020)
  • Midwestern Regional Medical Center, Inc. ( Site 0077)
  • Goshen Center for Cancer Care ( Site 0021)
  • MercyOne Waterloo Cancer Center ( Site 0016)
  • James Graham Brown Cancer Center ( Site 0022)
  • Maryland Oncology Hematology, P.A. ( Site 8007)
  • Massachusetts General Hospital ( Site 0024)
  • MGH - North Shore Cancer Center ( Site 0081)
  • MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)
  • Henry Ford Health System ( Site 0028)
  • Mayo Clinic and Medical School (Rochester) ( Site 0029)
  • St. Vincent Frontier Cancer Center ( Site 0033)
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)
  • Holy Name Medical Center ( Site 0041)
  • Weill Cornell Medical College ( Site 0043)
  • CTCA Southwestern ( Site 0074)
  • OHSU Knight Cancer Institute ( Site 0051)
  • Northwest Cancer Specialists, P.C. ( Site 8000)
  • Geisinger Medical Center ( Site 0052)
  • Fox Chase Cancer Center ( Site 0078)
  • Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)
  • Medical University of South Carolina ( Site 0053)
  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)
  • Texas Oncology-Austin Central ( Site 8004)
  • Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)
  • Texas Oncology-Memorial City ( Site 8012)
  • University of Texas-MD Anderson Cancer Center ( Site 0083)
  • Texas Oncology- Plano East ( Site 8010)
  • Texas Oncology-Tyler ( Site 8006)
  • Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)
  • Virginia Oncology Associates ( Site 8001)
  • Kadlec Clinic Hematology and Oncology ( Site 0070)
  • Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)
  • Chris OBrien Lifehouse ( Site 2107)
  • Royal North Shore Hospital ( Site 2100)
  • Westmead Hospital ( Site 2101)
  • Mater Misericordiae Ltd ( Site 2106)
  • Frankston Hospital ( Site 2103)
  • Peter MacCallum Cancer Centre ( Site 2102)
  • Imelda Ziekenhuis Bonheiden ( Site 0703)
  • UZ Antwerpen - Medical Oncology ( Site 0709)
  • Institut Jules Bordet ( Site 0710)
  • Cliniques Universitaires Saint-Luc ( Site 0701)
  • CHC MontLegia ( Site 0707)
  • Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)
  • CHU UCL Namur Site de Godinne ( Site 0706)
  • AZ Maria Middelares Gent ( Site 0700)
  • UZ Leuven ( Site 0702)
  • AZ Groeninge ( Site 0705)
  • Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
  • Associacao Hospitalar Moinhos de Vento ( Site 0201)
  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)
  • CEPON - Centro de Pesquisas Oncologicas ( Site 0208)
  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)
  • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)
  • Instituto Nacional de Cancer - INCA HC III ( Site 0200)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)
  • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)
  • Cross Cancer Institute ( Site 0115)
  • BC Cancer-Vancouver Center ( Site 0116)
  • Princess Margaret Cancer Centre ( Site 0112)
  • CISSS de la Monteregie-Centre ( Site 0108)
  • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)
  • Jewish General Hospital ( Site 0103)
  • Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)
  • CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)
  • Anhui Provincial Hospital ( Site 3224)
  • Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)
  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)
  • Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)
  • Fourth Hospital Of Hebei Medical University ( Site 3216)
  • Harbin Medical University Cancer Hospital ( Site 3200)
  • Henan Cancer Hospital ( Site 3212)
  • Hubei Cancer Hospital ( Site 3211)
  • Hunan Cancer Hospital ( Site 3214)
  • The First Affiliated Hospital of Zhejiang University ( Site 3203)
  • The First Hospital of Jilin University ( Site 3201)
  • Fudan University Shanghai Cancer Center ( Site 3205)
  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)
  • Tianjin Medical University Cancer Institute & Hospital ( Site 3209)
  • Cancer Hospital Affiliated to Xinjiang Medical University ( Site 3219)
  • Zhejiang Provincial People's Hospital ( Site 3225)
  • Zhejiang Cancer Hospital.... ( Site 3210)
  • Clínica Vida Fundación - Sede Poblado ( Site 0405)
  • Rodrigo Botero SAS ( Site 0407)
  • Clinica de la Costa Ltda. ( Site 0400)
  • Oncomedica S.A. ( Site 0401)
  • Centro de Investigacion Clinica del Country ( Site 0402)
  • Fundacion Universitaria Sanitas ( Site 0403)
  • Centro Medico Imbanaco de Cali S.A ( Site 0406)
  • Hospital Metropolitano - Sede Lindora ( Site 4203)
  • Centre Francois Baclesse ( Site 0927)
  • Centre Georges Francois Leclerc ( Site 0920)
  • Institut Claudius Regaud IUCT Oncopole ( Site 0903)
  • Institut Curie - Centre Rene Huguenin ( Site 0917)
  • Centre de Cancerologie du Grand Montpellier ( Site 0925)
  • CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)
  • Centre Oscar Lambret ( Site 0911)
  • Institut Sainte Catherine ( Site 0916)
  • Centre Jean Perrin ( Site 0909)
  • Clinique Victor Hugo ( Site 0906)
  • Institut Gustave Roussy ( Site 0926)
  • Institut Curie ( Site 0900)
  • Hopital Saint-Louis ( Site 0908)
  • Hopital Tenon ( Site 0914)
  • Medizinische Management GmbH ( Site 1012)
  • Universitaetsklinikum Erlangen ( Site 1001)
  • Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)
  • Sana Klinikum Offenbach GmbH ( Site 1002)
  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)
  • Gynaekologisch-onkologische Praxis Hannover ( Site 1013)
  • Gynaekologisches Zentrum ( Site 1003)
  • Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)
  • Frauenklinik St. Louise ( Site 1014)
  • Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)
  • Universitaetsklinikum Carl Gustav Carus ( Site 1008)
  • MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)
  • Bacs-Kiskun Megyei Korhaz ( Site 2913)
  • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)
  • Szent Margit Korhaz ( Site 2901)
  • Orszagos Onkologiai Intezet ( Site 2908)
  • Uzsoki Utcai Korhaz ( Site 2902)
  • Debreceni Egyetem Klinikai Kozpont ( Site 2907)
  • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)
  • Bon Secours Hospital ( Site 1554)
  • St. James s Hospital ( Site 1553)
  • HaEmek Medical Center ( Site 1712)
  • Assuta Ashdod Public ( Site 1704)
  • Soroka Medical Center ( Site 1701)
  • Rambam Health Care Campus-Oncology Division ( Site 1705)
  • Shaare Zedek Medical Center ( Site 1708)
  • Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)
  • Meir Medical Center ( Site 1710)
  • Holy Family Hospital ( Site 1711)
  • Rabin Medical Center ( Site 1702)
  • Chaim Sheba Medical Center. ( Site 1707)
  • Kaplan Medical Center ( Site 1703)
  • Sourasky Medical Center ( Site 1706)
  • Assuta Medical Center ( Site 1709)
  • Aichi Cancer Center Hospital ( Site 2601)
  • National Cancer Center Hospital East ( Site 2613)
  • National Hospital Organization Hokkaido Cancer Center ( Site 2607)
  • Hyogo College of Medicine Hospital ( Site 2600)
  • Kitasato University Hospital ( Site 2616)
  • Saitama Medical University International Medical Center ( Site 2606)
  • Saitama Cancer Center ( Site 2612)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 2611)
  • Chiba Cancer Center ( Site 2605)
  • Fukushima Medical University Hospital ( Site 2610)
  • Hiroshima City Hiroshima Citizens Hospital ( Site 2603)
  • Kumamoto University Hospital ( Site 2602)
  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26
  • Toranomon Hospital ( Site 2608)
  • The Cancer Institute Hospital of JFCR ( Site 2604)
  • Showa University Hospital ( Site 2615)
  • National Cancer Center ( Site 2204)
  • Asan Medical Center ( Site 2202)
  • Seoul National University Hospital ( Site 2200)
  • Severance Hospital Yonsei University Health System ( Site 2201)
  • Samsung Medical Center ( Site 2203)
  • Tauranga Hospital ( Site 2302)
  • Canterbury Regional Cancer & Blood Services ( Site 2303)
  • Capital & Coast District Health Board - Wellington Hospital ( Site 2301)
  • Dolnoslaskie Centrum Onkologii. ( Site 1820)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)
  • Instytut Centrum Zdrowia Matki Polki ( Site 1821)
  • Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
  • Mazowiecki Szpital Onkologiczny ( Site 1803)
  • Bialostockie Centrum Onkologii ( Site 1819)
  • Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)
  • Szpitale Pomorskie Sp. z o.o. ( Site 1818)
  • Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)
  • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)
  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)
  • Fundacao Champalimaud ( Site 2500)
  • CHLN Hospital Santa Maria ( Site 2501)
  • Hospital Geral de Santo Antonio ( Site 2503)
  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)
  • UPR Comprehensive Cancer Center ( Site 6200)
  • Arkhangelsk Clinical Oncological Dispensary ( Site 1901)
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)
  • N.N. Blokhin NMRCO ( Site 1908)
  • Central Clinical Hospital with outpatient Clinic ( Site 1907)
  • Medical Rehabilitation Center ( Site 1912)
  • Ryazan Regional Clinical Oncology Dispensary ( Site 1910)
  • Railway Hospital of OJSC ( Site 1913)
  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1903)
  • Tomsk Scientific Research Institute of Oncology ( Site 1905)
  • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)
  • Hospital Teresa Herrera - Chuac ( Site 1358)
  • Hospital General Universitario Gregorio Maranon ( Site 1367)
  • Hospital Quiron de Madrid ( Site 1351)
  • Hospital Clinico Universitario de Valencia ( Site 1355)
  • Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)
  • Hospital Vall D Hebron ( Site 1357)
  • Hospital Clinic I Provincial de Barcelona ( Site 1353)
  • Complejo Hospitalario de Jaen ( Site 1364)
  • Hospital Ruber Internacional ( Site 1370)
  • Hospital Clinico San Carlos ( Site 1354)
  • Hospital Universitario 12 de Octubre ( Site 1356)
  • Hospital Universitario Virgen del Rocio ( Site 1360)
  • Hospital General Arnau de Vilanova de Valencia ( Site 1369)
  • China Medical University Hospital ( Site 2401)
  • National Cheng Kung University Hospital ( Site 2400)
  • National Taiwan University Hospital ( Site 2404)
  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)
  • Linkou Chang Gung Memorial Hospital ( Site 2402)
  • Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 2702)
  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)
  • MI Precarpathian Clinical Oncology Center ( Site 2707)
  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)
  • Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
  • Khmelnitskiy Regional Onkology Dispensary ( Site 2704)
  • National Cancer Institute of the MoH of Ukraine ( Site 2719)
  • MI Odesa Regional Clinical Hospital ( Site 2701)
  • MI Odessa Regional Oncological Centre ( Site 2714)
  • Medical center of the Limited Liability Company Yulis ( Site 2720)
  • Kyiv City Clinical Oncology Centre ( Site 2716)
  • University Hospitals Bristol NHS Foundation Trust ( Site 1503)
  • Nottingham University Hospitals NHS Trust ( Site 1504)
  • Colchester General Hospital ( Site 1508)
  • Barts Health NHS Trust ( Site 1500)
  • Guy's Hospital ( Site 1501)
  • St. Georges University Hospital NHS Foundation Trust ( Site 1505)
  • Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)
  • Royal Cornwall Hospital ( Site 1502)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab+Chemotherapy (KX/KA[E]C)

Placebo+Chemotherapy (PX/PA[E]C)

Arm Description

In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.

In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.

Outcomes

Primary Outcome Measures

Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0
The pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pathological Complete Response (pCR) using the definition of (ypT0/Tis ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
Event-Free Survival (EFS)
EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator will be presented.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies will be presented.
pCR Rate Using the Definition of ypT0ypN0
pCR rate (ypT0ypN0) is defined as the percentage of participants without residual invasive or in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of (ypT0ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
pCR Rate Using the Definition of ypT0/Tis
pCR rate (ypT0/Tis) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen (independent of lymph node involvement) after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of ypT0/Tis will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
pCR Rate Using the Definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in Participants With a Combined Positive Score [CPS] ≥1
pCR rates were calculated using the definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the three definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in participants with a CPS ≥1 (with a positive Programmed Cell Death-Ligand 1 [PD-L1] tumor status) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
EFS in Participants With a CPS ≥1
EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator for participants with a CPS ≥1 will be presented.
OS in Participants With a CPS ≥1
OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies for participants with a CPS ≥1 will be presented.
Number of Participants Experiencing an Adverse Event (AE)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.
Number of Participants Experiencing a Serious Adverse Event (SAE)
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect. The number of participants who experience an SAE while receiving pembrolizumab or placebo (including 3 months of safety follow up) will be presented.
Number of Participants Experiencing an Immune-related AE (irAE)
Some AEs that may occur in this study that are known to be related to pembrolizumab immunotherapy treatment and may include: pneumonitis, diarrhea/colitis, aspartate aminotransferase/alanine aminotransferase (AST/ALT) elevation or increased bilirubin, Type 1 diabetes mellitus or hyperglycemia, hypophysitis, hyperthyroidism, hypothyroidism, nephritis and renal dysfunction, and myocarditis. The number of participants who experience an irAE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.
Number of Participants who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment (pembrolizumab or placebo) due to an AE will be presented.
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses for each of 28 items are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome, and responses for each of 2 items (overall health and overall quality of life) are given on a 7-point scale (1=Very poor to 7=Excellent), with a higher score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC-QLQ-C30 scores for participants will be presented.
Change from Baseline in EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) Score
The EORTC QLQ-BR23 is a 23-item questionnaire developed to assess the quality of life in women with breast cancer. Responses for each item are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC QLQ-BR23 score for participants will be presented.

Full Information

First Posted
October 29, 2018
Last Updated
September 26, 2023
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03725059
Brief Title
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
Official Title
A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
January 24, 2031 (Anticipated)
Study Completion Date
January 24, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
Detailed Description
Study participants will receive 8 cycles of neoadjuvant study treatment and then will undergo surgery for their breast cancer. After surgery, participants will receive 9 cycles of study treatment and up to 10 years of variable endocrine therapy. Each cycle is 21 days long.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
PD1, PD-1, PDL1, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab+Chemotherapy (KX/KA[E]C)
Arm Type
Experimental
Arm Description
In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.
Arm Title
Placebo+Chemotherapy (PX/PA[E]C)
Arm Type
Placebo Comparator
Arm Description
In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab (K)
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion Q3W
Intervention Type
Drug
Intervention Name(s)
Placebo (P)
Intervention Description
Normal saline or dextrose IV infusion Q3W
Intervention Type
Drug
Intervention Name(s)
Paclitaxel (X)
Other Intervention Name(s)
TAXOL®
Intervention Description
IV infusion QW
Intervention Type
Drug
Intervention Name(s)
Doxorubicin (A)
Other Intervention Name(s)
ADRIAMYCIN®
Intervention Description
IV infusion either in Q2W or Q3W
Intervention Type
Drug
Intervention Name(s)
Epirubicin (E)
Other Intervention Name(s)
ELLENCE®
Intervention Description
IV infusion either in Q2W or Q3W
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (C)
Other Intervention Name(s)
CYTOXAN®
Intervention Description
IV infusion either in Q2W or Q3W
Intervention Type
Drug
Intervention Name(s)
Endocrine therapy
Intervention Description
Variable endocrine therapy for up 10 years
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Variable radiation therapy per local standard of care
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery for breast cancer
Primary Outcome Measure Information:
Title
Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0
Description
The pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pathological Complete Response (pCR) using the definition of (ypT0/Tis ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
Time Frame
Up to approximately 7 months (Time of surgery)
Title
Event-Free Survival (EFS)
Description
EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator will be presented.
Time Frame
Up to approximately 12 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies will be presented.
Time Frame
Up to approximately 12 years
Title
pCR Rate Using the Definition of ypT0ypN0
Description
pCR rate (ypT0ypN0) is defined as the percentage of participants without residual invasive or in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of (ypT0ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
Time Frame
Up to approximately 7 months (Time of surgery)
Title
pCR Rate Using the Definition of ypT0/Tis
Description
pCR rate (ypT0/Tis) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen (independent of lymph node involvement) after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of ypT0/Tis will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
Time Frame
Up to approximately 7 months (Time of surgery)
Title
pCR Rate Using the Definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in Participants With a Combined Positive Score [CPS] ≥1
Description
pCR rates were calculated using the definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the three definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in participants with a CPS ≥1 (with a positive Programmed Cell Death-Ligand 1 [PD-L1] tumor status) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
Time Frame
Up to approximately 7 months (Time of surgery)
Title
EFS in Participants With a CPS ≥1
Description
EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator for participants with a CPS ≥1 will be presented.
Time Frame
Up to approximately 12 years
Title
OS in Participants With a CPS ≥1
Description
OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies for participants with a CPS ≥1 will be presented.
Time Frame
Up to approximately 12 years
Title
Number of Participants Experiencing an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.
Time Frame
Up to approximately 15 months
Title
Number of Participants Experiencing a Serious Adverse Event (SAE)
Description
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect. The number of participants who experience an SAE while receiving pembrolizumab or placebo (including 3 months of safety follow up) will be presented.
Time Frame
Up to approximately 17 months
Title
Number of Participants Experiencing an Immune-related AE (irAE)
Description
Some AEs that may occur in this study that are known to be related to pembrolizumab immunotherapy treatment and may include: pneumonitis, diarrhea/colitis, aspartate aminotransferase/alanine aminotransferase (AST/ALT) elevation or increased bilirubin, Type 1 diabetes mellitus or hyperglycemia, hypophysitis, hyperthyroidism, hypothyroidism, nephritis and renal dysfunction, and myocarditis. The number of participants who experience an irAE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.
Time Frame
Up to approximately 15 months
Title
Number of Participants who Discontinued Study Treatment Due to an AE
Description
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment (pembrolizumab or placebo) due to an AE will be presented.
Time Frame
Up to approximately 14 months
Title
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score
Description
The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses for each of 28 items are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome, and responses for each of 2 items (overall health and overall quality of life) are given on a 7-point scale (1=Very poor to 7=Excellent), with a higher score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC-QLQ-C30 scores for participants will be presented.
Time Frame
Baseline (Cycle 1 Day 1 in Treatment 1) and Cycles 1 and 4 Day 1 in Treatment 2 (Up to approximately 5 months) Each cycle is 21 days.
Title
Change from Baseline in EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) Score
Description
The EORTC QLQ-BR23 is a 23-item questionnaire developed to assess the quality of life in women with breast cancer. Responses for each item are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC QLQ-BR23 score for participants will be presented.
Time Frame
Baseline (Cycle 1 Day 1 in Treatment 1) and Cycles 1 and 4 Day 1 in Treatment 2 (Up to approximately 5 months) Each cycle is 21 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed. Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines. Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status. Note: Sponsor agreement is required for formalin-fixed paraffin-embedded (FFPE) tumor tissue sample or slides that were obtained greater than 60 days prior to the date that the documented informed consent was obtained. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment. Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period. Female participants must agree to use effective contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo. Has adequate organ function. Exclusion Criteria: Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis. Has breast cancer with lobular histology. Has bilateral invasive breast cancer. Has metastatic (Stage IV) breast cancer. Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast). Has any of the following clinical lymph node staging per current American Joint Committee on Cancer (AJCC) staging criteria for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c. Has ER-, progesterone receptor positive breast cancer. Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or has undergone sentinel lymph node biopsy prior to study treatment. Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Has a known history of active tuberculosis (Bacillus tuberculosis). Has an active infection requiring systemic therapy. Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening. Has other significant cardiac disease, such as: 1) History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months. or 2) Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV. Has a known history of human immunodeficiency virus (HIV) infection. Has a known history of hepatitis B or known active hepatitis C virus infection. Has received prior treatment for breast cancer. Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137). Has received a live vaccine within 30 days prior to the first dose of study treatment. Has severe hypersensitivity (≥Grade 3) to any of the components or excipients used in the study treatments. Is/was enrolled in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks (12 months for an investigational agent or device with anticancer or antiproliferative properties) prior to the first dose of study treatment. Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center, PC ( Site 8003)
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Arizona Oncology Associates PC- HOPE ( Site 8008)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
El Camino Hospital Cancer Center ( Site 0004)
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Stanford Cancer Center ( Site 0072)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center ( Site 0073)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Cancer Center ( Site 0008)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Baptist MD Anderson Cancer Center ( Site 0014)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Southeastern Regional Medical Center, Inc. ( Site 0075)
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
The University of Chicago Medical Center ( Site 0080)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Orchard Healthcare Research Inc. ( Site 0020)
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Midwestern Regional Medical Center, Inc. ( Site 0077)
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Goshen Center for Cancer Care ( Site 0021)
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
MercyOne Waterloo Cancer Center ( Site 0016)
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
James Graham Brown Cancer Center ( Site 0022)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Maryland Oncology Hematology, P.A. ( Site 8007)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Massachusetts General Hospital ( Site 0024)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
MGH - North Shore Cancer Center ( Site 0081)
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Henry Ford Health System ( Site 0028)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic and Medical School (Rochester) ( Site 0029)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Vincent Frontier Cancer Center ( Site 0033)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Holy Name Medical Center ( Site 0041)
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Weill Cornell Medical College ( Site 0043)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
CTCA Southwestern ( Site 0074)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
OHSU Knight Cancer Institute ( Site 0051)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Northwest Cancer Specialists, P.C. ( Site 8000)
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Geisinger Medical Center ( Site 0052)
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Fox Chase Cancer Center ( Site 0078)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Medical University of South Carolina ( Site 0053)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology-Austin Central ( Site 8004)
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology-Memorial City ( Site 8012)
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
University of Texas-MD Anderson Cancer Center ( Site 0083)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Texas Oncology- Plano East ( Site 8010)
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Texas Oncology-Tyler ( Site 8006)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Virginia Oncology Associates ( Site 8001)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology ( Site 0070)
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Chris OBrien Lifehouse ( Site 2107)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal North Shore Hospital ( Site 2100)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital ( Site 2101)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater Misericordiae Ltd ( Site 2106)
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Frankston Hospital ( Site 2103)
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Peter MacCallum Cancer Centre ( Site 2102)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Imelda Ziekenhuis Bonheiden ( Site 0703)
City
Bonheiden
State/Province
Antwerpen
ZIP/Postal Code
2820
Country
Belgium
Facility Name
UZ Antwerpen - Medical Oncology ( Site 0709)
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Institut Jules Bordet ( Site 0710)
City
Anderlecht
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc ( Site 0701)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHC MontLegia ( Site 0707)
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
CHU UCL Namur Site de Godinne ( Site 0706)
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
AZ Maria Middelares Gent ( Site 0700)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 0702)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Groeninge ( Site 0705)
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Associacao Hospitalar Moinhos de Vento ( Site 0201)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
CEPON - Centro de Pesquisas Oncologicas ( Site 0208)
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCA HC III ( Site 0200)
City
Rio de Janeiro
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)
City
Sao Paulo
ZIP/Postal Code
01317-001
Country
Brazil
Facility Name
Cross Cancer Institute ( Site 0115)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer-Vancouver Center ( Site 0116)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0112)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CISSS de la Monteregie-Centre ( Site 0108)
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Jewish General Hospital ( Site 0103)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Anhui Provincial Hospital ( Site 3224)
City
Heifei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)
City
Shanghai
State/Province
Anhui
ZIP/Postal Code
200025
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)
City
Fuzhou Fujian
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510289
Country
China
Facility Name
Fourth Hospital Of Hebei Medical University ( Site 3216)
City
Shijia Zhuang
State/Province
Hebei
ZIP/Postal Code
050019
Country
China
Facility Name
Harbin Medical University Cancer Hospital ( Site 3200)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital ( Site 3212)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hubei Cancer Hospital ( Site 3211)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital ( Site 3214)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University ( Site 3203)
City
Hangzhou
State/Province
Jiangsu
ZIP/Postal Code
310003
Country
China
Facility Name
The First Hospital of Jilin University ( Site 3201)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 3205)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital ( Site 3209)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 3219)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Zhejiang Provincial People's Hospital ( Site 3225)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Zhejiang Cancer Hospital.... ( Site 3210)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Clínica Vida Fundación - Sede Poblado ( Site 0405)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Facility Name
Rodrigo Botero SAS ( Site 0407)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Facility Name
Clinica de la Costa Ltda. ( Site 0400)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 0401)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230001
Country
Colombia
Facility Name
Centro de Investigacion Clinica del Country ( Site 0402)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Fundacion Universitaria Sanitas ( Site 0403)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111221
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 0406)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Hospital Metropolitano - Sede Lindora ( Site 4203)
City
Santa Ana
State/Province
San Jose
ZIP/Postal Code
10903
Country
Costa Rica
Facility Name
Centre Francois Baclesse ( Site 0927)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Facility Name
Centre Georges Francois Leclerc ( Site 0920)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21079
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0903)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Curie - Centre Rene Huguenin ( Site 0917)
City
Saint-Cloud
State/Province
Hauts-de-Seine
ZIP/Postal Code
92210
Country
France
Facility Name
Centre de Cancerologie du Grand Montpellier ( Site 0925)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34070
Country
France
Facility Name
CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)
City
Metz
State/Province
Moselle
ZIP/Postal Code
57085
Country
France
Facility Name
Centre Oscar Lambret ( Site 0911)
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59000
Country
France
Facility Name
Institut Sainte Catherine ( Site 0916)
City
Avignon
State/Province
Provence-Alpes-Cote-d Azur
ZIP/Postal Code
84918
Country
France
Facility Name
Centre Jean Perrin ( Site 0909)
City
Clermont Ferrand Cedex
State/Province
Puy-de-Dome
ZIP/Postal Code
63011
Country
France
Facility Name
Clinique Victor Hugo ( Site 0906)
City
Le Mans
State/Province
Sarthe
ZIP/Postal Code
72000
Country
France
Facility Name
Institut Gustave Roussy ( Site 0926)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Institut Curie ( Site 0900)
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Saint-Louis ( Site 0908)
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Tenon ( Site 0914)
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Medizinische Management GmbH ( Site 1012)
City
Friedrichshafen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
88045
Country
Germany
Facility Name
Universitaetsklinikum Erlangen ( Site 1001)
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Sana Klinikum Offenbach GmbH ( Site 1002)
City
Offenbach
State/Province
Hessen
ZIP/Postal Code
63069
Country
Germany
Facility Name
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
Facility Name
Gynaekologisch-onkologische Praxis Hannover ( Site 1013)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30177
Country
Germany
Facility Name
Gynaekologisches Zentrum ( Site 1003)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53111
Country
Germany
Facility Name
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Frauenklinik St. Louise ( Site 1014)
City
Paderborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
60314
Country
Germany
Facility Name
Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)
City
Saarbruecken
State/Province
Saarland
ZIP/Postal Code
66113
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus ( Site 1008)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)
City
Nordhausen
State/Province
Thuringen
ZIP/Postal Code
99734
Country
Germany
Facility Name
Bacs-Kiskun Megyei Korhaz ( Site 2913)
City
Kecskemet
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szent Margit Korhaz ( Site 2901)
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet ( Site 2908)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz ( Site 2902)
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 2907)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Bon Secours Hospital ( Site 1554)
City
Cork
ZIP/Postal Code
T12 DV56
Country
Ireland
Facility Name
St. James s Hospital ( Site 1553)
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
HaEmek Medical Center ( Site 1712)
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Assuta Ashdod Public ( Site 1704)
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Soroka Medical Center ( Site 1701)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 1705)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center ( Site 1708)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center ( Site 1710)
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Holy Family Hospital ( Site 1711)
City
Nazareth
ZIP/Postal Code
1641101
Country
Israel
Facility Name
Rabin Medical Center ( Site 1702)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 1707)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Kaplan Medical Center ( Site 1703)
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1706)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assuta Medical Center ( Site 1709)
City
Tel Aviv
ZIP/Postal Code
6789140
Country
Israel
Facility Name
Aichi Cancer Center Hospital ( Site 2601)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 2613)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center ( Site 2607)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo College of Medicine Hospital ( Site 2600)
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kitasato University Hospital ( Site 2616)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 2606)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Cancer Center ( Site 2612)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 2611)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Chiba Cancer Center ( Site 2605)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Fukushima Medical University Hospital ( Site 2610)
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital ( Site 2603)
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Kumamoto University Hospital ( Site 2602)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Toranomon Hospital ( Site 2608)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 2604)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Showa University Hospital ( Site 2615)
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
National Cancer Center ( Site 2204)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2202)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 2200)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 2201)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2203)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Tauranga Hospital ( Site 2302)
City
Tauranga
State/Province
Bay Of Plenty
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Canterbury Regional Cancer & Blood Services ( Site 2303)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Capital & Coast District Health Board - Wellington Hospital ( Site 2301)
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Dolnoslaskie Centrum Onkologii. ( Site 1820)
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki ( Site 1821)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)
City
Ostroleka
State/Province
Mazowieckie
ZIP/Postal Code
07-410
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Mazowiecki Szpital Onkologiczny ( Site 1803)
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Bialostockie Centrum Onkologii ( Site 1819)
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o. ( Site 1818)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)
City
Bielsko-Biala
State/Province
Slaskie
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)
City
Bytom
State/Province
Slaskie
ZIP/Postal Code
41-900
Country
Poland
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Fundacao Champalimaud ( Site 2500)
City
Lisboa
State/Province
Aveiro
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
CHLN Hospital Santa Maria ( Site 2501)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio ( Site 2503)
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
UPR Comprehensive Cancer Center ( Site 6200)
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Arkhangelsk Clinical Oncological Dispensary ( Site 1901)
City
Arkhangelsk
State/Province
Arkhangel Skaya Oblast
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
N.N. Blokhin NMRCO ( Site 1908)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Central Clinical Hospital with outpatient Clinic ( Site 1907)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Medical Rehabilitation Center ( Site 1912)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Oncology Dispensary ( Site 1910)
City
Ryazan
State/Province
Ryazanskaya Oblast
ZIP/Postal Code
390013
Country
Russian Federation
Facility Name
Railway Hospital of OJSC ( Site 1913)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1903)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Tomsk Scientific Research Institute of Oncology ( Site 1905)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Teresa Herrera - Chuac ( Site 1358)
City
A Coruna
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 1367)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Quiron de Madrid ( Site 1351)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia ( Site 1355)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46011
Country
Spain
Facility Name
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital Vall D Hebron ( Site 1357)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona ( Site 1353)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Complejo Hospitalario de Jaen ( Site 1364)
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Ruber Internacional ( Site 1370)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos ( Site 1354)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre ( Site 1356)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio ( Site 1360)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Arnau de Vilanova de Valencia ( Site 1369)
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
China Medical University Hospital ( Site 2401)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 2400)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 2404)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)
City
Taipei
ZIP/Postal Code
11259
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital ( Site 2402)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 2702)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)
City
Kryviy Rih
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
MI Precarpathian Clinical Oncology Center ( Site 2707)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
City
Antonivka Village
State/Province
Khersonska Oblast
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Khmelnitskiy Regional Onkology Dispensary ( Site 2704)
City
Khmelnitskiy
State/Province
Khmelnytska Oblast
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 2719)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
MI Odesa Regional Clinical Hospital ( Site 2701)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre ( Site 2714)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Medical center of the Limited Liability Company Yulis ( Site 2720)
City
Zaporizhzhia
State/Province
Zaporizka Oblast
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Centre ( Site 2716)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
University Hospitals Bristol NHS Foundation Trust ( Site 1503)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust ( Site 1504)
City
Nottingham
State/Province
England
ZIP/Postal Code
ng5 1pb
Country
United Kingdom
Facility Name
Colchester General Hospital ( Site 1508)
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Barts Health NHS Trust ( Site 1500)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Guy's Hospital ( Site 1501)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RY
Country
United Kingdom
Facility Name
St. Georges University Hospital NHS Foundation Trust ( Site 1505)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)
City
Solihull
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Royal Cornwall Hospital ( Site 1502)
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

We'll reach out to this number within 24 hrs