search
Back to results

A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

Primary Purpose

Carcinoma, Squamous Cell, Non-small-cell Lung

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Carboplatin
Paclitaxel
Nab-paclitaxel
Olaparib
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell, Non-small-cell Lung focused on measuring PD-1, PD L1, PD L2

Eligibility Criteria

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

Inclusion Criteria:

  1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
  2. Have Stage IV squamous NSCLC.
  3. Have measurable disease based on RECIST 1.1.
  4. Have not received prior systemic treatment for their advanced/metastatic NSCLC.

  5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.

    Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.

  6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
  7. Have a life expectancy of at least 3 months.
  8. Has adequate organ function.
  9. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
  10. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

Exclusion Criteria:

  1. Has non-squamous histology NSCLC.
  2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
  3. Has known active central nervous system metastases and/or carcinomatous meningitis.
  4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
  5. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  6. Has an active autoimmune disease that has required systemic treatment in past 2 years.
  7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
  9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
  10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
  11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
  12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

Sites / Locations

  • Alabama Oncology Bruno Cancer Center ( Site 0001)
  • Disney Family Cancer Center ( Site 0005)
  • Boca Raton Regional Hospital ( Site 0018)
  • Mid-Florida Cancer Centers ( Site 0022)
  • H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)
  • Columbus Regional Research Institute ( Site 0099)
  • Mount Sinai Hospital Medical Center ( Site 0035)
  • Oncology of Northshore ( Site 0036)
  • Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)
  • MedStar Franklin Square Medical Center ( Site 0044)
  • Barbara Ann Karmanos Cancer Institute ( Site 0046)
  • Hattiesburg Clinic ( Site 0051)
  • Frontier Oncology ( Site 0052)
  • Bozeman Health Deaconness Cancer Center ( Site 0053)
  • Waverly Hematology Oncology ( Site 0054)
  • Thompson Cancer Survival Center ( Site 2812)
  • Renovatio Clinical ( Site 0074)
  • Cancer Care Northwest ( Site 0083)
  • Hospital Italiano Regional del Sur ( Site 0509)
  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)
  • Hospital Britanico de Buenos Aires ( Site 0500)
  • Instituto Medico Rio Cuarto ( Site 0501)
  • Sanatorio Parque ( Site 0515)
  • Centro Oncológico de Rosario ( Site 0507)
  • Centro Medico San Roque ( Site 0506)
  • Hospital Italiano de Buenos Aires ( Site 0511)
  • Clínica Universitaria Reina Fabiola ( Site 0505)
  • Sanatorio Privado San Geronimo S.R.L ( Site 0510)
  • Liverpool Hospital ( Site 1201)
  • Southern Medical Day Care Centre ( Site 1200)
  • Townsville General Hospital ( Site 1202)
  • Monash Cancer Centre ( Site 1205)
  • Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
  • Klinikum Wels-Grieskirchen ( Site 1304)
  • Innsbruck LKH ( Site 1302)
  • Social Medical Center - Otto Wagner Hospital ( Site 1301)
  • Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
  • Hospital Sao Rafael ( Site 0258)
  • Instituto do Cancer do Ceara ( Site 0251)
  • Oncologica do Brasil ( Site 0256)
  • Hospital Tacchini ( Site 0265)
  • Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)
  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)
  • Hospital de Base de Sao Jose de Rio Preto ( Site 0254)
  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)
  • Hospital Paulistano - Amil Clinical Research ( Site 0263)
  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)
  • Nova Scotia Health Authority ( Site 0103)
  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)
  • Kingston Health Sciences Centre ( Site 0102)
  • Stronach Regional Cancer Centre ( Site 0100)
  • CISSS de la Monteregie-Centre ( Site 0101)
  • Hopital Cite de la Sante de Laval ( Site 0105)
  • CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
  • CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)
  • Centre Hospitalier De Chauny ( Site 1411)
  • CHU Caen ( Site 1406)
  • CHU Angers ( Site 1405)
  • Institut De Cancerologie De Lorraine ( Site 1409)
  • Hopital Robert Schuman ( Site 1402)
  • Centre Jean Perrin ( Site 1407)
  • Centre Hospitalier de Pau ( Site 1412)
  • CHU de Rouen ( Site 1403)
  • Hopital d'Instruction des Armees Begin ( Site 1413)
  • Studienzentrum Aschaffenburg ( Site 1575)
  • Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)
  • Klinikum der LMU ( Site 1550)
  • Universitaetsklinikum Regensburg ( Site 1562)
  • Klinikum Wuerzburg Mitte gGmbH ( Site 1559)
  • Universitaetsklinikum Frankfurt ( Site 1563)
  • Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)
  • Universitaetsmedizin Goettingen ( Site 1557)
  • Universitaetsklinikum Bonn ( Site 1574)
  • Kliniken Essen Mitte ( Site 1567)
  • InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)
  • Helios Klinikum Erfurt GmbH ( Site 1552)
  • Katholisches Marienkrankenhaus gGmbH ( Site 1572)
  • National Hospital Organization Nagoya Medical Center ( Site 0806)
  • Aichi Cancer Center Hospital ( Site 0803)
  • National Cancer Center Hospital East ( Site 0801)
  • Kurume University Hospital ( Site 0814)
  • Kanazawa University Hospital ( Site 0811)
  • Kanagawa Cancer Center ( Site 0807)
  • Sendai Kousei Hospital ( Site 0812)
  • Kansai Medical University Hospital ( Site 0804)
  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
  • National Hospital Organization Kyushu Medical Center ( Site 0805)
  • Niigata Cancer Center Hospital ( Site 0808)
  • Okayama University Hospital ( Site 0810)
  • Osaka International Cancer Institute ( Site 0809)
  • The Cancer Institute Hospital of JFCR ( Site 0800)
  • Chungbuk National University Hospital ( Site 1002)
  • National Cancer Center ( Site 1006)
  • The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
  • Ajou University Hospital ( Site 1004)
  • Gyeongsang National University Hospital ( Site 1005)
  • Asan Medical Center ( Site 1007)
  • Seoul National University Hospital ( Site 1000)
  • Severance Hospital Yonsei University Health System ( Site 1001)
  • Korea University Guro Hospital ( Site 1008)
  • Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)
  • Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)
  • Axis Heilsa S. de R.L. de C.V. ( Site 0301)
  • CLIMERS Clinical Medical Research ( Site 0306)
  • Arke Estudios Clinicos ( Site 0333)
  • FAICIC Clinical Research ( Site 0303)
  • MidCentral DHB Palmerston North Hospital ( Site 1102)
  • Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)
  • Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
  • Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
  • Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
  • Przychodnia Lekarska Komed ( Site 2416)
  • MED-POLONIA Sp. z o.o. ( Site 2419)
  • Cardiomed SRL Cluj-Napoca ( Site 2504)
  • S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
  • Policlinica Oncomed SRL ( Site 2505)
  • S.C.Focus Lab Plus S.R.L ( Site 2502)
  • Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)
  • Moscow Regional Oncological Dispensary ( Site 2028)
  • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
  • First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
  • Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
  • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
  • Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
  • Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
  • SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
  • SBHI Leningrad Regional Clinical Hospital ( Site 2002)
  • SPb Central Clinical Railway Hospital ( Site 2003)
  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
  • SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)
  • Hospital Duran i Reynals ( Site 1710)
  • Complejo Hospitalario de Jaen ( Site 1713)
  • Hospital Sant Creu i Sant Pau ( Site 1711)
  • Hospital Universitario 12 de Octubre ( Site 1716)
  • Complejo Hospitalario de Malaga ( Site 1714)
  • Hospital Universitario Virgen Macarena ( Site 1712)
  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
  • China Medical University Hospital ( Site 0904)
  • National Cheng Kung University Hospital ( Site 0905)
  • National Taiwan University Hospital ( Site 0900)
  • Mackay Memorial Hospital ( Site 0902)
  • Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
  • Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
  • Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
  • Gazi Universitesi Tip Fakultesi ( Site 2104)
  • Ankara Sehir Hastanesi ( Site 2105)
  • Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
  • Ege Universitesi Tip Fakultesi ( Site 2109)
  • Erciyes Universitesi Tip Fakultesi ( Site 2108)
  • Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)
  • Cherkasy Regional Oncology Dispensary ( Site 2225)
  • City Clinical Hosp.4 of DCC ( Site 2215)
  • MI Precarpathian Clinical Oncology Center ( Site 2218)
  • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)
  • Regional Centre of Oncology-Thoracic organs ( Site 2219)
  • PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)
  • Medical Center Asklepion LLC ( Site 2243)
  • Kyiv City Clinical Oncology Centre ( Site 2224)
  • Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)
  • MI Odessa Regional Oncological Centre ( Site 2222)
  • Central City Clinical Hospital ( Site 2221)
  • Medical Center Verum ( Site 2228)
  • Southend University Hospital NHS Foundation Trust ( Site 1913)
  • Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
  • Chelsea and Westminster Hospital ( Site 1901)
  • Newcastle Freeman Hospital ( Site 1902)
  • West Suffolk Hospitals NHS Trust ( Site 1919)
  • Singleton Hospital ( Site 1909)
  • Colchester General Hospital ( Site 1911)
  • Birmingham Heartlands Hospital ( Site 1910)
  • Western General Hospital, Edinburgh ( Site 1924)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab + Carboplatin + Taxane + Olaparib

Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo

Arm Description

For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.

For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is the time from the date of randomization to death due to any cause.

Secondary Outcome Measures

Number of Participants With One or More Adverse Events (AEs)
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of participants discontinuing study intervention due to adverse events (AEs)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health 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 scores will be presented.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" 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. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest 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. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" 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 EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health 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. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores.

Full Information

First Posted
June 3, 2019
Last Updated
August 22, 2022
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03976362
Brief Title
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Official Title
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2019 (Actual)
Primary Completion Date
May 6, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (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 current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).
Detailed Description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell, Non-small-cell Lung
Keywords
PD-1, PD L1, PD L2

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Carboplatin + Taxane + Olaparib
Arm Type
Experimental
Arm Description
For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Arm Title
Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo
Arm Type
Active Comparator
Arm Description
For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®, ONXAL™
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
ABRAXANE®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
LYNPARZA®
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to olaparib, tablets
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Description
Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 3 years
Title
Overall Survival (OS)
Description
Overall survival is the time from the date of randomization to death due to any cause.
Time Frame
Up to approximately 5 years
Secondary Outcome Measure Information:
Title
Number of Participants With One or More Adverse Events (AEs)
Description
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 5 years
Title
Number of participants discontinuing study intervention due to adverse events (AEs)
Description
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time Frame
Up to approximately 5 years
Title
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health 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 scores will be presented.
Time Frame
Baseline (at randomization) and Week 18 post-randomization
Title
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" 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. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
Time Frame
Baseline (at randomization) and Week 18 post-randomization
Title
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest 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. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
Time Frame
Baseline (at randomization) and Week 18 post-randomization
Title
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" 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 EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome.
Time Frame
Baseline (at randomization) and Week 18 post-randomization
Title
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
Time Frame
Baseline (at randomization) and Week 18 post-randomization
Title
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 30) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health 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. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores.
Time Frame
Up to approximately 5 years
Title
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score.
Time Frame
Up to approximately 5 years
Title
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
Description
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How was your chest 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score.
Time Frame
Up to approximately 5 years
Title
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score.
Time Frame
Up to approximately 5 years
Title
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores.
Time Frame
Up to approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a histologically or cytologically confirmed diagnosis squamous NSCLC. Have Stage IV squamous NSCLC. Have measurable disease based on RECIST 1.1. Have not received prior systemic treatment for their advanced/metastatic NSCLC. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention Have a life expectancy of at least 3 months. Has adequate organ function. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards. Exclusion Criteria: Has non-squamous histology NSCLC. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment. Has known active central nervous system metastases and/or carcinomatous meningitis. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Has an active autoimmune disease that has required systemic treatment in past 2 years. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
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
Alabama Oncology Bruno Cancer Center ( Site 0001)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Disney Family Cancer Center ( Site 0005)
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Boca Raton Regional Hospital ( Site 0018)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Mid-Florida Cancer Centers ( Site 0022)
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Columbus Regional Research Institute ( Site 0099)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Mount Sinai Hospital Medical Center ( Site 0035)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Oncology of Northshore ( Site 0036)
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
MedStar Franklin Square Medical Center ( Site 0044)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute ( Site 0046)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hattiesburg Clinic ( Site 0051)
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Frontier Oncology ( Site 0052)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Bozeman Health Deaconness Cancer Center ( Site 0053)
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Waverly Hematology Oncology ( Site 0054)
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Thompson Cancer Survival Center ( Site 2812)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37804
Country
United States
Facility Name
Renovatio Clinical ( Site 0074)
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Cancer Care Northwest ( Site 0083)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Hospital Italiano Regional del Sur ( Site 0509)
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
B8001HXM
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires ( Site 0500)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Instituto Medico Rio Cuarto ( Site 0501)
City
Rio Cuarto
State/Province
Cordoba
ZIP/Postal Code
X5800AEV
Country
Argentina
Facility Name
Sanatorio Parque ( Site 0515)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Centro Oncológico de Rosario ( Site 0507)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Centro Medico San Roque ( Site 0506)
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IAK
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires ( Site 0511)
City
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Clínica Universitaria Reina Fabiola ( Site 0505)
City
Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Sanatorio Privado San Geronimo S.R.L ( Site 0510)
City
Santa Fe
ZIP/Postal Code
S3000AOL
Country
Argentina
Facility Name
Liverpool Hospital ( Site 1201)
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Southern Medical Day Care Centre ( Site 1200)
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Townsville General Hospital ( Site 1202)
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Monash Cancer Centre ( Site 1205)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen ( Site 1304)
City
Wels
State/Province
Oberosterreich
ZIP/Postal Code
4600
Country
Austria
Facility Name
Innsbruck LKH ( Site 1302)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Social Medical Center - Otto Wagner Hospital ( Site 1301)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1145
Country
Austria
Facility Name
Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
City
Wien
ZIP/Postal Code
1210
Country
Austria
Facility Name
Hospital Sao Rafael ( Site 0258)
City
Salvador - BA
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Instituto do Cancer do Ceara ( Site 0251)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Oncologica do Brasil ( Site 0256)
City
Belem
State/Province
Para
ZIP/Postal Code
66053-000
Country
Brazil
Facility Name
Hospital Tacchini ( Site 0265)
City
Bento Goncalves
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95700-000
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 0254)
City
Sao Jose Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Paulistano - Amil Clinical Research ( Site 0263)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Nova Scotia Health Authority ( Site 0103)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
Kingston Health Sciences Centre ( Site 0102)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Stronach Regional Cancer Centre ( Site 0100)
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
CISSS de la Monteregie-Centre ( Site 0101)
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hopital Cite de la Sante de Laval ( Site 0105)
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada
Facility Name
CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Centre Hospitalier De Chauny ( Site 1411)
City
Chauny
State/Province
Aisne
ZIP/Postal Code
02300
Country
France
Facility Name
CHU Caen ( Site 1406)
City
Caen
State/Province
Calvados
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Angers ( Site 1405)
City
Angers
State/Province
Maine-et-Loire
ZIP/Postal Code
49100
Country
France
Facility Name
Institut De Cancerologie De Lorraine ( Site 1409)
City
Vandoeuvre les Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54519
Country
France
Facility Name
Hopital Robert Schuman ( Site 1402)
City
Vantoux
State/Province
Moselle
ZIP/Postal Code
57070
Country
France
Facility Name
Centre Jean Perrin ( Site 1407)
City
Clermont Ferrand
State/Province
Puy-de-Dome
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Hospitalier de Pau ( Site 1412)
City
Pau
State/Province
Pyrenees-Atlantiques
ZIP/Postal Code
64000
Country
France
Facility Name
CHU de Rouen ( Site 1403)
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76000
Country
France
Facility Name
Hopital d'Instruction des Armees Begin ( Site 1413)
City
Saint-Mande
State/Province
Val-de-Marne
ZIP/Postal Code
94163
Country
France
Facility Name
Studienzentrum Aschaffenburg ( Site 1575)
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81925
Country
Germany
Facility Name
Klinikum der LMU ( Site 1550)
City
Munich
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitaetsklinikum Regensburg ( Site 1562)
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93042
Country
Germany
Facility Name
Klinikum Wuerzburg Mitte gGmbH ( Site 1559)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97074
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt ( Site 1563)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)
City
Immenhausen
State/Province
Hessen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Universitaetsmedizin Goettingen ( Site 1557)
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaetsklinikum Bonn ( Site 1574)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Kliniken Essen Mitte ( Site 1567)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)
City
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Helios Klinikum Erfurt GmbH ( Site 1552)
City
Erfurt
State/Province
Thuringen
ZIP/Postal Code
99089
Country
Germany
Facility Name
Katholisches Marienkrankenhaus gGmbH ( Site 1572)
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 0806)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Aichi Cancer Center Hospital ( Site 0803)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 0801)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kurume University Hospital ( Site 0814)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 0811)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kanagawa Cancer Center ( Site 0807)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Sendai Kousei Hospital ( Site 0812)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Kansai Medical University Hospital ( Site 0804)
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 0805)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 0808)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital ( Site 0810)
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 0809)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 0800)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Chungbuk National University Hospital ( Site 1002)
City
Cheongju si
State/Province
Chungbuk
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
National Cancer Center ( Site 1006)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Ajou University Hospital ( Site 1004)
City
Suwon
State/Province
Kyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital ( Site 1005)
City
Jinju
State/Province
Kyongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 1007)
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 1000)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 1001)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 1008)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)
City
La Paz
State/Province
Baja California Sur
ZIP/Postal Code
23040
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Axis Heilsa S. de R.L. de C.V. ( Site 0301)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
CLIMERS Clinical Medical Research ( Site 0306)
City
Orizaba
State/Province
Veracruz
ZIP/Postal Code
94300
Country
Mexico
Facility Name
Arke Estudios Clinicos ( Site 0333)
City
Cdmx
ZIP/Postal Code
06700
Country
Mexico
Facility Name
FAICIC Clinical Research ( Site 0303)
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
MidCentral DHB Palmerston North Hospital ( Site 1102)
City
Palmerston North
State/Province
Manawatu-Wanganui
ZIP/Postal Code
4414
Country
New Zealand
Facility Name
Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)
City
Olsztyn
State/Province
Dolnoslaskie
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
City
Zgorzelec
State/Province
Dolnoslaskie
ZIP/Postal Code
59-900
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-202
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
Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
City
Raciborz
State/Province
Slaskie
ZIP/Postal Code
47-400
Country
Poland
Facility Name
Przychodnia Lekarska Komed ( Site 2416)
City
Konin
State/Province
Wielkopolskie
ZIP/Postal Code
62-500
Country
Poland
Facility Name
MED-POLONIA Sp. z o.o. ( Site 2419)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Cardiomed SRL Cluj-Napoca ( Site 2504)
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Facility Name
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
Policlinica Oncomed SRL ( Site 2505)
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Facility Name
S.C.Focus Lab Plus S.R.L ( Site 2502)
City
Bucuresti
ZIP/Postal Code
022548
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Moscow Regional Oncological Dispensary ( Site 2028)
City
Balashikha
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143900
Country
Russian Federation
Facility Name
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
City
Omsk
State/Province
Omskaya Oblast
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
SBHI Leningrad Regional Clinical Hospital ( Site 2002)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
SPb Central Clinical Railway Hospital ( Site 2003)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Hospital Duran i Reynals ( Site 1710)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Complejo Hospitalario de Jaen ( Site 1713)
City
Jaen
State/Province
La Coruna
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Sant Creu i Sant Pau ( Site 1711)
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre ( Site 1716)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Complejo Hospitalario de Malaga ( Site 1714)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena ( Site 1712)
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 0904)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0905)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0900)
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Mackay Memorial Hospital ( Site 0902)
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
City
Tekirdag
State/Province
Tekirdas
ZIP/Postal Code
59100
Country
Turkey
Facility Name
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultesi ( Site 2104)
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Ankara Sehir Hastanesi ( Site 2105)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi ( Site 2109)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Erciyes Universitesi Tip Fakultesi ( Site 2108)
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)
City
Samsun
ZIP/Postal Code
55270
Country
Turkey
Facility Name
Cherkasy Regional Oncology Dispensary ( Site 2225)
City
Cherkasy
State/Province
Cherkaska Oblast
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
City Clinical Hosp.4 of DCC ( Site 2215)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
MI Precarpathian Clinical Oncology Center ( Site 2218)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Regional Centre of Oncology-Thoracic organs ( Site 2219)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)
City
Kropyvnytskyi
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Medical Center Asklepion LLC ( Site 2243)
City
Khodosivka
State/Province
Kyivska Oblast
ZIP/Postal Code
08173
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Centre ( Site 2224)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre ( Site 2222)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Central City Clinical Hospital ( Site 2221)
City
Uzhgorod
State/Province
Zakarpatska Oblast
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Medical Center Verum ( Site 2228)
City
Kyiv
ZIP/Postal Code
03039
Country
Ukraine
Facility Name
Southend University Hospital NHS Foundation Trust ( Site 1913)
City
Westcliff-on-Sea
State/Province
Essex
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital ( Site 1901)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Newcastle Freeman Hospital ( Site 1902)
City
Newcastle-upon-Tyne
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
West Suffolk Hospitals NHS Trust ( Site 1919)
City
Bury Saint Edmunds
State/Province
Suffolk
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
Facility Name
Singleton Hospital ( Site 1909)
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Colchester General Hospital ( Site 1911)
City
Colchester
State/Province
Worcestershire
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital ( Site 1910)
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Western General Hospital, Edinburgh ( Site 1924)
City
Edinburg
ZIP/Postal Code
EH4 2XU
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
http://merckoncologyclinicaltrials.com
Description
Merck Oncology Clinical Trial Information

Learn more about this trial

A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

We'll reach out to this number within 24 hrs