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Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)

Primary Purpose

Ovarian Cancer, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Paclitaxel
Bevacizumab
Placebo for pembrolizumab
Docetaxel
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

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

Inclusion Criteria:

  • Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-PD-1/anti-PD-L1 therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.
  • Has provided documented informed consent for the study.
  • Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease).
  • Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization.
  • For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of <1% per year).
  • Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the local site investigator.
  • Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided.
  • Have adequate organ function.

Exclusion Criteria:

  • Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
  • Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy.
  • Has prior disease progression on weekly paclitaxel alone.
  • Has received >2 prior lines of systemic therapy for OC.
  • Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization.
  • Has received prior radiation therapy within 2 weeks of start of study intervention.
  • Has not recovered adequately from surgery and/or any complications from the surgery.
  • Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor,[GM-CSF] or recombinant erythropoietin) within 4 weeks before randomization.
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
  • Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • 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 a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
  • Has had an allogenic tissue/solid organ transplant.

For bevacizumab treatment

  • Has uncontrolled hypertension.
  • Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
  • Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.

Sites / Locations

  • HonorHealth ( Site 0041)
  • Marin Cancer Care ( Site 0055)
  • Pacific Cancer Care ( Site 0028)
  • Eisenhower Medical Center ( Site 0067)
  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)
  • University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054
  • Sarasota Memorial Hospital ( Site 0018)
  • Moffitt Cancer Center ( Site 0033)
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)
  • Advocate Medical Group-Oncology ( Site 0049)
  • Parkview Research Center at Parkview Regional Medical Center ( Site 0027)
  • St. Vincent Hospital and Health Care Center, Inc ( Site 0032)
  • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)
  • WK Physicians Network / Hematology Oncology Associates ( Site 0034)
  • Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)
  • University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)
  • Roswell Park Cancer Institute ( Site 0039)
  • Columbia University Medical Center ( Site 0010)
  • Novant Health Presbyterian Medical Center ( Site 0029)
  • Duke Cancer Institute ( Site 0038)
  • Novant Health Forsyth Medical Center ( Site 0057)
  • Aultman Hospital-Oncology Clinical Trials ( Site 0009)
  • MetroHealth Medical Center-Cancer Care Center ( Site 0047)
  • Providence Portland Medical Center ( Site 0048)
  • University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)
  • Sanford Cancer Center ( Site 0064)
  • The West Clinic, PLLC dba West Cancer Center ( Site 0058)
  • Texas Oncology - Dallas (Presbyterian) ( Site 0065)
  • Texas Oncology - The Woodlands_Lee ( Site 0043)
  • Inova Schar Cancer Institute ( Site 0019)
  • Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
  • Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)
  • Epworth Freemasons ( Site 0204)
  • St. John of God Subiaco Hospital ( Site 0203)
  • Institut Jules Bordet-Medicine Oncology ( Site 0302)
  • UZ Gent-Medical oncology ( Site 0301)
  • UZ Leuven ( Site 0303)
  • AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)
  • Hospital Araújo Jorge ( Site 0401)
  • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)
  • ANIMI - Unidade de Tratamento Oncologico ( Site 0408)
  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)
  • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)
  • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)
  • Tom Baker Cancer Center ( Site 0511)
  • BC Cancer Abbotsford ( Site 0512)
  • BC Cancer Victoria ( Site 0513)
  • Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog
  • Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)
  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)
  • Jewish General Hospital ( Site 0505)
  • McGill University Health Centre ( Site 0502)
  • Saskatoon Cancer Center ( Site 0510)
  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
  • James Lind Centro de Investigación del Cáncer ( Site 0602)
  • CIDO SpA-Oncology ( Site 0608)
  • Clínica Puerto Montt ( Site 0601)
  • Oncovida ( Site 0603)
  • Instituto de Radiomedicina-hemato-oncologia ( Site 0604)
  • Clínica Vespucio-Hemato - Ocology ( Site 0607)
  • Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)
  • Bradfordhill ( Site 0605)
  • Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)
  • Beijing Cancer hospital ( Site 0711)
  • Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)
  • Fujian Provincial Cancer Hospital ( Site 0713)
  • Lanzhou university second hospital ( Site 0734)
  • Zhujiang Hospital ( Site 0739)
  • Affiliated Hospital of Guangdong Medical University ( Site 0743)
  • Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)
  • Hainan General Hospital ( Site 0736)
  • Henan Cancer Hospital ( Site 0718)
  • Wuhan Union Hospital-Medical Oncology ( Site 0735)
  • Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)
  • Xiangya Hospital Central South University-Gynecology ( Site 0705)
  • Hunan Cancer Hospital ( Site 0704)
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
  • Zhongda Hospital Southeast University ( Site 0723)
  • Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)
  • The First Hospital of Jilin University ( Site 0710)
  • Shandong Cancer Hospital-Oncology Department ( Site 0733)
  • LinYi Cancer Hospital ( Site 0731)
  • Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)
  • Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)
  • Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)
  • West China Second University Hospital Sichuan University ( Site 0740)
  • Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)
  • Tianjin Medical University Cancer Institute and Hospital ( Site 0720)
  • Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)
  • The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)
  • The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)
  • Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)
  • Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)
  • Clínica Universitaria Colombia ( Site 0806)
  • Oncologos del Occidente ( Site 0807)
  • Hemato Oncologos SA ( Site 0801)
  • Aalborg Universitetshospital, Syd ( Site 0901)
  • Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
  • Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi
  • Centre François Baclesse-Recherche clinique ( Site 2904)
  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)
  • Institut Curie - site Saint-Cloud ( Site 2909)
  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)
  • Centre de Cancérologie du Grand Montpellier ( Site 2908)
  • Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)
  • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)
  • Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)
  • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)
  • Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)
  • CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)
  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
  • Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)
  • Charité Campus Virchow-Klinikum ( Site 1201)
  • Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)
  • St. James's Hospital-Cancer clinical trials office ( Site 2821)
  • Emek Medical Center-Gyn-Onc ( Site 1406)
  • Soroka Medical Center ( Site 1404)
  • Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
  • Shaare Zedek Medical Center ( Site 1405)
  • Rabin Medical Center ( Site 1401)
  • Sheba Medical Center ( Site 1407)
  • Sourasky Medical Center ( Site 1403)
  • IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)
  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)
  • Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)
  • ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)
  • Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)
  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)
  • Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)
  • Aichi Cancer Center Hospital ( Site 1610)
  • National Cancer Center Hospital East ( Site 1609)
  • National Hospital Organization Shikoku Cancer Center ( Site 1603)
  • Ehime University Hospital ( Site 1606)
  • Kurume University Hospital ( Site 1607)
  • Hokkaido University Hospital ( Site 1604)
  • Iwate Medical University Hospital ( Site 1613)
  • Nippon Medical School Musashi Kosugi Hospital ( Site 1614)
  • Saitama Medical University International Medical Center ( Site 1601)
  • Shizuoka Cancer Center ( Site 1611)
  • National Cancer Center Hospital ( Site 1612)
  • Japanese Foundation for Cancer Research ( Site 1605)
  • Osaka International Cancer Institute ( Site 1602)
  • Seoul National University Hospital ( Site 2302)
  • Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)
  • Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)
  • Gangnam Severance Hospital ( Site 2301)
  • Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)
  • COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)
  • INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)
  • iCan Oncology Center Centro Medico AVE ( Site 1704)
  • Centro de Investigacion Clinica de Oaxaca ( Site 1705)
  • Radboudumc ( Site 1802)
  • Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)
  • Erasmus Medisch Centrum-Medical Oncology ( Site 1803)
  • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)
  • Auckland City Hospital ( Site 1901)
  • Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)
  • Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit
  • Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)
  • Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)
  • Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21
  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)
  • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit
  • Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary
  • Ogarev Mordovia State University ( Site 2209)
  • Moscow City Oncology Hospital #62 ( Site 2214)
  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)
  • SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)
  • cukurova universty ( Site 2706)
  • Istanbul Universitesi Cerrahpasa ( Site 2709)
  • Ege University Medicine of Faculty ( Site 2702)
  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)
  • Ankara University Hospital Cebeci ( Site 2701)
  • Baskent Universitesi Ankara Hastanesi ( Site 2707)
  • Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)
  • T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma
  • Brighton and Sussex University Hospitals NHS Trust ( Site 2803)
  • Addenbrooke's Hospital ( Site 2808)
  • The Royal Cornwall Hospital ( Site 2804)
  • Westmorland General Hospital ( Site 2815)
  • Ninewells Hospital and Medical School ( Site 2826)
  • Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)
  • Hammersmith Hospital-Medical Oncology ( Site 2818)
  • Velindre Cancer Centre ( Site 2805)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab + paclitaxel ± bevacizumab

Placebo + paclitaxel ± bevacizumab

Arm Description

Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be presented.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
PFS per RECIST 1.1 by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be presented.
Number of Participants who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a 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 will be reported.
Number of Participants who Discontinue Study Treatment due to an AE
An AE is any untoward medical occurrence in a 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 due to an AE will be reported.
Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.

Full Information

First Posted
October 28, 2021
Last Updated
August 4, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05116189
Brief Title
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
Official Title
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
August 31, 2027 (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 primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 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
616 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + paclitaxel ± bevacizumab
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
Arm Title
Placebo + paclitaxel ± bevacizumab
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 every 3 weeks [Q3W]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475,, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
AVASTIN®, Zirabev
Intervention Description
IV infusion
Intervention Type
Other
Intervention Name(s)
Placebo for pembrolizumab
Other Intervention Name(s)
normal saline or dextrose
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
TAXOTERE®
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be presented.
Time Frame
Up to ~38 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
Time Frame
Up to ~64 months
Title
PFS per RECIST 1.1 by Blinded Independent Central Review (BICR)
Description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be presented.
Time Frame
Up to ~38 months
Title
Number of Participants who Experience an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a 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 will be reported.
Time Frame
Up to ~64 months
Title
Number of Participants who Discontinue Study Treatment due to an AE
Description
An AE is any untoward medical occurrence in a 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 due to an AE will be reported.
Time Frame
Up to ~64 months
Title
Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Time Frame
Baseline and up to ~64 months
Title
Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30
Description
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Time Frame
Up to ~64 months
Title
Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
Description
The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
Time Frame
Baseline and up to ~64 months
Title
TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale
Description
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Time Frame
Up to ~64 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-PD-1/anti-PD-L1 therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy. Has provided documented informed consent for the study. Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease). Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using). Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization. For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of <1% per year). Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the local site investigator. Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided. Have adequate organ function. Exclusion Criteria: Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma. Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy. Has prior disease progression on weekly paclitaxel alone. Has received >2 prior lines of systemic therapy for OC. Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization. Has received prior radiation therapy within 2 weeks of start of study intervention. Has not recovered adequately from surgery and/or any complications from the surgery. Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor,[GM-CSF] or recombinant erythropoietin) within 4 weeks before randomization. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients. Has an active autoimmune disease that has required systemic treatment in the past 2 years. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Has an active infection requiring systemic therapy. 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 a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study. Has had an allogenic tissue/solid organ transplant. For bevacizumab treatment Has uncontrolled hypertension. Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam. Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.
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
HonorHealth ( Site 0041)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Marin Cancer Care ( Site 0055)
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Pacific Cancer Care ( Site 0028)
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Eisenhower Medical Center ( Site 0067)
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Sarasota Memorial Hospital ( Site 0018)
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Moffitt Cancer Center ( Site 0033)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Advocate Medical Group-Oncology ( Site 0049)
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Parkview Research Center at Parkview Regional Medical Center ( Site 0027)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
St. Vincent Hospital and Health Care Center, Inc ( Site 0032)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
WK Physicians Network / Hematology Oncology Associates ( Site 0034)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Institute ( Site 0039)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Columbia University Medical Center ( Site 0010)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Novant Health Presbyterian Medical Center ( Site 0029)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Cancer Institute ( Site 0038)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Novant Health Forsyth Medical Center ( Site 0057)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Aultman Hospital-Oncology Clinical Trials ( Site 0009)
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
MetroHealth Medical Center-Cancer Care Center ( Site 0047)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Providence Portland Medical Center ( Site 0048)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Sanford Cancer Center ( Site 0064)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
The West Clinic, PLLC dba West Cancer Center ( Site 0058)
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology - Dallas (Presbyterian) ( Site 0065)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology - The Woodlands_Lee ( Site 0043)
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Inova Schar Cancer Institute ( Site 0019)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Epworth Freemasons ( Site 0204)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
St. John of God Subiaco Hospital ( Site 0203)
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Institut Jules Bordet-Medicine Oncology ( Site 0302)
City
Bruxelles
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Gent-Medical oncology ( Site 0301)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 0303)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Hospital Araújo Jorge ( Site 0401)
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
ANIMI - Unidade de Tratamento Oncologico ( Site 0408)
City
Lages
State/Province
Santa Catarina
ZIP/Postal Code
88501001
Country
Brazil
Facility Name
BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Facility Name
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Tom Baker Cancer Center ( Site 0511)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
BC Cancer Abbotsford ( Site 0512)
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 0C2
Country
Canada
Facility Name
BC Cancer Victoria ( Site 0513)
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Jewish General Hospital ( Site 0505)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
McGill University Health Centre ( Site 0502)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Saskatoon Cancer Center ( Site 0510)
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
James Lind Centro de Investigación del Cáncer ( Site 0602)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
CIDO SpA-Oncology ( Site 0608)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810148
Country
Chile
Facility Name
Clínica Puerto Montt ( Site 0601)
City
Puerto Montt
State/Province
Los Lagos
ZIP/Postal Code
5500243
Country
Chile
Facility Name
Oncovida ( Site 0603)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Instituto de Radiomedicina-hemato-oncologia ( Site 0604)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7630370
Country
Chile
Facility Name
Clínica Vespucio-Hemato - Ocology ( Site 0607)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8241479
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Bradfordhill ( Site 0605)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Beijing Cancer hospital ( Site 0711)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 0713)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Lanzhou university second hospital ( Site 0734)
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
Zhujiang Hospital ( Site 0739)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
Affiliated Hospital of Guangdong Medical University ( Site 0743)
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524004
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Hainan General Hospital ( Site 0736)
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Henan Cancer Hospital ( Site 0718)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Wuhan Union Hospital-Medical Oncology ( Site 0735)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Xiangya Hospital Central South University-Gynecology ( Site 0705)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital ( Site 0704)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Zhongda Hospital Southeast University ( Site 0723)
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University ( Site 0710)
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shandong Cancer Hospital-Oncology Department ( Site 0733)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
LinYi Cancer Hospital ( Site 0731)
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276001
Country
China
Facility Name
Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201204
Country
China
Facility Name
West China Second University Hospital Sichuan University ( Site 0740)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610066
Country
China
Facility Name
Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital ( Site 0720)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650106
Country
China
Facility Name
The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
3100000
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050030
Country
Colombia
Facility Name
Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Clínica Universitaria Colombia ( Site 0806)
City
Bogotá
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111221
Country
Colombia
Facility Name
Oncologos del Occidente ( Site 0807)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Facility Name
Hemato Oncologos SA ( Site 0801)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
76001
Country
Colombia
Facility Name
Aalborg Universitetshospital, Syd ( Site 0901)
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20521
Country
Finland
Facility Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
Centre François Baclesse-Recherche clinique ( Site 2904)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
Institut Curie - site Saint-Cloud ( Site 2909)
City
Saint-Cloud
State/Province
Hauts-de-Seine
ZIP/Postal Code
92210
Country
France
Facility Name
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35042
Country
France
Facility Name
Centre de Cancérologie du Grand Montpellier ( Site 2908)
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34070
Country
France
Facility Name
Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44277
Country
France
Facility Name
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47805
Country
Germany
Facility Name
CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66113
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Charité Campus Virchow-Klinikum ( Site 1201)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)
City
Hamburg
ZIP/Postal Code
22307
Country
Germany
Facility Name
St. James's Hospital-Cancer clinical trials office ( Site 2821)
City
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Facility Name
Emek Medical Center-Gyn-Onc ( Site 1406)
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Soroka Medical Center ( Site 1404)
City
Be'er Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center ( Site 1405)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Rabin Medical Center ( Site 1401)
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center ( Site 1407)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1403)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)
City
Milan
State/Province
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 1610)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 1609)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 1603)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Ehime University Hospital ( Site 1606)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kurume University Hospital ( Site 1607)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hokkaido University Hospital ( Site 1604)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Iwate Medical University Hospital ( Site 1613)
City
Shiwa-gun Yahaba-cho
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Nippon Medical School Musashi Kosugi Hospital ( Site 1614)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 1601)
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
350-1200
Country
Japan
Facility Name
Shizuoka Cancer Center ( Site 1611)
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 1612)
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Japanese Foundation for Cancer Research ( Site 1605)
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 1602)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Seoul National University Hospital ( Site 2302)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital ( Site 2301)
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)
City
La Paz
State/Province
Baja California Sur
ZIP/Postal Code
23040
Country
Mexico
Facility Name
COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
04700
Country
Mexico
Facility Name
INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14070
Country
Mexico
Facility Name
iCan Oncology Center Centro Medico AVE ( Site 1704)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Centro de Investigacion Clinica de Oaxaca ( Site 1705)
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Radboudumc ( Site 1802)
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum-Medical Oncology ( Site 1803)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Auckland City Hospital ( Site 1901)
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)
City
Tromsø
State/Province
Troms
ZIP/Postal Code
9038
Country
Norway
Facility Name
Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)
City
Kielce
State/Province
Swietokrzyskie
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary
City
Chelyabinsk
State/Province
Chelyabinskaya Oblast
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Ogarev Mordovia State University ( Site 2209)
City
Saransk
State/Province
Mordoviya, Respublika
ZIP/Postal Code
430005
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62 ( Site 2214)
City
Krasnogorsk D-t
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)
City
Ekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620905
Country
Russian Federation
Facility Name
cukurova universty ( Site 2706)
City
Sarçam
State/Province
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa ( Site 2709)
City
Fatih
State/Province
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege University Medicine of Faculty ( Site 2702)
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Ankara University Hospital Cebeci ( Site 2701)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Baskent Universitesi Ankara Hastanesi ( Site 2707)
City
Ankara
ZIP/Postal Code
34180
Country
Turkey
Facility Name
Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma
City
Istanbul
ZIP/Postal Code
34440
Country
Turkey
Facility Name
Brighton and Sussex University Hospitals NHS Trust ( Site 2803)
City
East Sussex
State/Province
Brighton And Hove
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital ( Site 2808)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
The Royal Cornwall Hospital ( Site 2804)
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Westmorland General Hospital ( Site 2815)
City
Kendal
State/Province
Cumbria
ZIP/Postal Code
LA9 7RG
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School ( Site 2826)
City
Dundee
State/Province
Dundee City
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)
City
Leicester
State/Province
England
Country
United Kingdom
Facility Name
Hammersmith Hospital-Medical Oncology ( Site 2818)
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Velindre Cancer Centre ( Site 2805)
City
Cardiff
ZIP/Postal Code
CF14 2TL
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://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-B96&&kw=3475-B96
Description
Plain Language Summary

Learn more about this trial

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)

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