Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03221426 |
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Recruitment Status :
Recruiting
First Posted : July 18, 2017
Last Update Posted : May 28, 2020
|
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Brief Summary:
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
The primary study hypotheses are that:
- Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Overall Survival (OS), and Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
- Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastric Cancer Gastroesophageal Junction Cancer | Biological: Pembrolizumab Drug: Placebo Drug: Cisplatin Drug: Capecitabine Drug: 5-fluorouracil Drug: Docetaxel Drug: Oxaliplatin Drug: Leucovorin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double-blind study |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585) |
| Actual Study Start Date : | October 9, 2017 |
| Estimated Primary Completion Date : | June 28, 2024 |
| Estimated Study Completion Date : | June 28, 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Pembrolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pembrolizumab+Chemotherapy
Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 14 cycles. |
Biological: Pembrolizumab
IV infusion
Other Names:
Drug: Cisplatin IV infusion
Other Name: PLATINOL® Drug: Capecitabine Oral tablets
Other Name: XELODA® Drug: 5-fluorouracil IV infusion
Other Names:
|
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Placebo Comparator: Placebo+Chemotherapy
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 14 cycles. |
Drug: Placebo
IV infusion
Other Name: Normal saline solution Drug: Cisplatin IV infusion
Other Name: PLATINOL® Drug: Capecitabine Oral tablets
Other Name: XELODA® Drug: 5-fluorouracil IV infusion
Other Names:
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Experimental: Pembrolizumab+FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations. Adjuvant: 4 to 10 weeks postsurgery, participants receive pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations. |
Biological: Pembrolizumab
IV infusion
Other Names:
Drug: 5-fluorouracil IV infusion
Other Names:
Drug: Docetaxel IV infusion
Other Name: TAXOTERE® Drug: Oxaliplatin IV infusion
Other Name: ELOXATIN® Drug: Leucovorin IV infusion
Other Name: WELLCOVORIN® |
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Placebo Comparator: Placebo+FLOT Cohort
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations. Adjuvant: 4 to 10 weeks postsurgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations. |
Drug: Placebo
IV infusion
Other Name: Normal saline solution Drug: 5-fluorouracil IV infusion
Other Names:
Drug: Docetaxel IV infusion
Other Name: TAXOTERE® Drug: Oxaliplatin IV infusion
Other Name: ELOXATIN® Drug: Leucovorin IV infusion
Other Name: WELLCOVORIN® |
Primary Outcome Measures :
- Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to approximately 2 years ]OS is defined as the time from randomization to death due to any cause.
- Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to approximately 2 years ]EFS is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who are disease free after surgery); or death due to any cause. A second primary malignancy is not considered as an EFS event.
- Pathological Complete Response (pathCR) Rate - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to 6 weeks after completion of 3 cycles of neoadjuvant treatment (Up to 15 weeks) ]PathCR rate is defined as the percentage of participants having a pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
- Percentage of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 27 months ]An AE is defined as 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 percentage of participants who experience at least one AE will be presented.
- Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]An AE is defined as 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 percentage of participants who discontinue study treatment due to an AE will be presented.
Secondary Outcome Measures :
- Percentage of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms Separately and in Combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 27 months ]An AE is defined as 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 percentage of participants who experience at least one AE will be presented.
- Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms Separately and in Combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]An AE is defined as 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 percentage of participants who discontinue study treatment due to an AE will be presented.
- Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms [ Time Frame: Up to approximately 2 years ]DFS is defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by blinded independent central review.
- Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]OS is defined as the time from randomization to death due to any cause.
- Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts [ Time Frame: Up to approximately 2 years ]EFS is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who are disease free after surgery); or death due to any cause. A second primary malignancy is not considered as an EFS event.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
- Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.
- Is willing to provide tissue from a tumor lesion at baseline and at time of surgery.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 within 3 days prior to the first dose of study treatment.
- Has adequate organ function.
- Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
- Has life expectancy of greater than 6 months.
Exclusion Criteria:
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], necrosis factor receptor superfamily member 9 [CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
- Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients, or to any of the study chemotherapy agents and/or to any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- 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 known history of active tuberculosis (TB).
- Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.
- Male participants who are expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of chemotherapy.
- Has had an allogenic tissue/solid organ transplant.
- Has received a live vaccine within 30 days prior to the first dose of study treatment.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221426
Contacts
| Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
Locations
Hide 150 study locations
| United States, California | |
| City of Hope ( Site 0005) | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Study Coordinator 626-471-9200 | |
| United States, Connecticut | |
| Yale Cancer Center ( Site 0016) | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Study Coordinator 203-785-6661 | |
| United States, District of Columbia | |
| Georgetown University ( Site 0015) | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Study Coordinator 801-585-0330 | |
| United States, Illinois | |
| Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018) | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Study Coordinator 312-695-6180 | |
| The University of Chicago Medical Center ( Site 0004) | Completed |
| Chicago, Illinois, United States, 60637 | |
| United States, New York | |
| Roswell Park Cancer Institute ( Site 0001) | Completed |
| Buffalo, New York, United States, 14263 | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019) | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Study Coordinator 202-444-1781 | |
| Memorial Sloan Kettering ( Site 0024) | Completed |
| New York, New York, United States, 10065 | |
| Weill Cornell Medical Center ( Site 0023) | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Study Coordinator 646-962-6200 | |
| University of Rochester ( Site 0011) | Completed |
| Rochester, New York, United States, 14642 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center ( Site 0006) | Completed |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Temple University Hospital ( Site 0026) | Completed |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Utah | |
| University of Utah, Huntsman Cancer Institute ( Site 0012) | Completed |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Virginia | |
| Virginia Cancer Specialists, PC ( Site 0010) | Completed |
| Fairfax, Virginia, United States, 22031 | |
| Belgium | |
| Institut Jules Bordet ( Site 0480) | Recruiting |
| Brussels, Bruxelles-Capitale, Region De, Belgium, 1000 | |
| Contact: Study Coordinator +3225417209 | |
| Hopital Erasme ULB ( Site 0484) | Recruiting |
| Brussels, Bruxelles-Capitale, Region De, Belgium, 1070 | |
| Contact: Study Coordinator +3225553714 | |
| UCL Saint Luc ( Site 0479) | Recruiting |
| Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1200 | |
| Contact: Study Coordinator +3227641274 | |
| Grand Hopital de Charleroi ( Site 0478) | Recruiting |
| Charleroi, Hainaut, Belgium, 6000 | |
| Contact: Study Coordinator +3271104730 | |
| CHU UCL Namur Site de Godinne ( Site 0485) | Recruiting |
| Yvoir, Namur, Belgium, 5530 | |
| Contact: Study Coordinator +3281423858 | |
| UZ Gent ( Site 0486) | Recruiting |
| Gent, Oost-Vlaanderen, Belgium, 9000 | |
| Contact: Study Coordinator +3293329500 | |
| UZ Leuven ( Site 0483) | Recruiting |
| Leuven, Vlaams-Brabant, Belgium, 3000 | |
| Contact: Study Coordinator +3216344218 | |
| AZ Groeninge ( Site 0481) | Recruiting |
| Kortrijk, West-Vlaanderen, Belgium, 8500 | |
| Contact: Study Coordinator +3256633338 | |
| CHU - Sart Tilman ( Site 0482) | Recruiting |
| Liege, Belgium, 4000 | |
| Contact: Study Coordinator +3243667256 | |
| Brazil | |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308) | Recruiting |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000 | |
| Contact: Study Coordinator +555133203039 | |
| CEPON - Centro de Pesquisas Oncologicas ( Site 0302) | Recruiting |
| Florianopolis, Santa Catarina, Brazil, 88034-000 | |
| Contact: Study Coordinator +554833311553 | |
| Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301) | Recruiting |
| Barretos, Sao Paulo, Brazil, 14784-400 | |
| Contact: Study Coordinator +551733216637 | |
| Hospital de Base de Sao Jose de Rio Preto ( Site 0304) | Recruiting |
| Sao Jose Rio Preto, Sao Paulo, Brazil, 15090-000 | |
| Contact: Study Coordinator +551732015054 | |
| Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307) | Recruiting |
| Rio de Janeiro, Brazil, 20230-130 | |
| Contact: Study Coordinator +552132076564 | |
| Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305) | Recruiting |
| Sao Paulo, Brazil, 01246-000 | |
| Contact: Study Coordinator +551138932615 | |
| Hospital Israelita Albert Einstein ( Site 0309) | Recruiting |
| Sao Paulo, Brazil, 05652-900 | |
| Contact: Study Coordinator +551121510724 | |
| Canada, Alberta | |
| Cross Cancer Institute ( Site 0033) | Completed |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, New Brunswick | |
| Moncton Hospital - Horizon Health Network ( Site 0038) | Recruiting |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Contact: Study Coordinator 5068575669 | |
| Canada, Ontario | |
| Sunnybrook Research Institute ( Site 0032) | Completed |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| CISSS de la Monteregie-Centre ( Site 0039) | Completed |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040) | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: Study Coordinator 51425234005853 | |
| Jewish General Hospital ( Site 0034) | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Contact: Study Coordinator 5143408222 | |
| CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035) | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Study Coordinator 819346111016216 | |
| Canada | |
| CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042) | Completed |
| Quebec, Canada, G1R 2J6 | |
| Chile | |
| Instituto Clinico del Sur. ICOS ( Site 0290) | Recruiting |
| Temuco, Araucania, Chile, 4810469 | |
| Contact: Study Coordinator +56994443272 | |
| Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299) | Recruiting |
| Rancagua, Libertador General Bernardo O'Higgins, Chile, 2820000 | |
| Contact: Study Coordinator +56989022206 | |
| Fundacion Arturo Lopez Perez FALP ( Site 0286) | Recruiting |
| Santiago, Region Metropolitana De Santiago, Chile, 7500921 | |
| Contact: Study Coordinator +56224457254 | |
| Pontificia Universidad Catolica de Chile ( Site 0285) | Recruiting |
| Santiago, Region Metropolitana De Santiago, Chile, 8330032 | |
| Contact: Study Coordinator +56222472327 | |
| Hospital Clinico Universidad de Chile ( Site 0287) | Completed |
| Santiago, Region Metropolitana De Santiago, Chile, 8380456 | |
| France | |
| Hopital Prive Jean Mermoz ( Site 0462) | Completed |
| Lyon, Auvergne, France, 69008 | |
| Institut Paoli Calmettes ( Site 0472) | Recruiting |
| Marseille, Bouches-du-Rhone, France, 13009 | |
| Contact: Study Coordinator +33491223537 | |
| CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474) | Recruiting |
| Brest, Finistere, France, 29200 | |
| Contact: Study Coordinator +33298223428 | |
| CHU Toulouse - Hopital Rangueil ( Site 0470) | Recruiting |
| Toulouse, Haute-Garonne, France, 31059 | |
| Contact: Study Coordinator +33561322142 | |
| Institut du Cancer de Montpellier ( Site 0473) | Recruiting |
| Montpellier, Herault, France, 34298 | |
| Contact: Study Coordinator +33467613136 | |
| Centre Eugene Marquis ( Site 0466) | Recruiting |
| Rennes, Ille-et-Vilaine, France, 35042 | |
| Contact: Study Coordinator +33299253159 | |
| Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469) | Recruiting |
| Saint Herblain, Loire-Atlantique, France, 44805 | |
| Contact: Study Coordinator +33240679900 | |
| CHU Reims - Hopital Robert Debre ( Site 0465) | Recruiting |
| Reims, Marne, France, 51092 | |
| Contact: Study Coordinator +33326783113 | |
| CHRU Lille - Hopital Claude Huriez ( Site 0461) | Recruiting |
| Lille, Nord, France, 59037 | |
| Contact: Study Coordinator +33320444407 | |
| CHU Poitiers - Pole Regional de Cancerologie ( Site 0467) | Recruiting |
| Poitiers, Vienne, France, 86021 | |
| Contact: Study Coordinator +33549444951 | |
| CHU Hopital Saint Antoine ( Site 0471) | Recruiting |
| Paris, France, 75012 | |
| Contact: Study Coordinator +33171970401 | |
| Institut Mutualiste Montsouris ( Site 0463) | Recruiting |
| Paris, France, 75014 | |
| Contact: Study Coordinator +33156616241 | |
| Germany | |
| Klinikum Esslingen GmbH ( Site 0453) | Recruiting |
| Esslingen, Baden-Wurttemberg, Germany, 73730 | |
| Contact: Study Coordinator +4971131032451 | |
| Universitaetsklinikum Freiburg ( Site 0450) | Recruiting |
| Freiburg, Baden-Wurttemberg, Germany, 79106 | |
| Contact: Study Coordinator +4976127028080 | |
| Klinikum der Universitaet in Muenchen ( Site 0446) | Recruiting |
| Muenchen, Bayern, Germany, 81377 | |
| Contact: Study Coordinator +498944000 | |
| Medizinische Hochschule Hannover ( Site 0449) | Recruiting |
| Hannover, Niedersachsen, Germany, 30625 | |
| Contact: Study Coordinator +495115326727 | |
| Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445) | Recruiting |
| Essen, Nordrhein-Westfalen, Germany, 45136 | |
| Contact: Study Coordinator +4920117424524 | |
| Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455) | Recruiting |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Contact: Study Coordinator +496131176076 | |
| Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448) | Recruiting |
| Dresden, Sachsen, Germany, 01307 | |
| Contact: Study Coordinator +493514584794 | |
| Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454) | Recruiting |
| Hamburg, Germany, 20249 | |
| Contact: Study Coordinator +49404602001 | |
| Israel | |
| Soroka University M.C ( Site 0385) | Recruiting |
| Beer Sheva, HaDarom, Israel, 8410101 | |
| Contact: Study Coordinator +972864000798 | |
| Meir medical center ( Site 0386) | Recruiting |
| Kfar Saba, HaMerkaz, Israel, 4428164 | |
| Contact: Study Coordinator +97297472393 | |
| Rabin-Medical Center ( Site 0384) | Recruiting |
| Petah Tikva, HaMerkaz, Israel, 4963211 | |
| Contact: Study Coordinator +97239378081 | |
| Rambam Health Care Campus ( Site 0381) | Recruiting |
| Haifa, Heifa, Israel, 3525408 | |
| Contact: Study Coordinator +97247776731 | |
| Sheba Medical center ( Site 0387) | Recruiting |
| Ramat Gan, Tell Abib, Israel, 5265601 | |
| Contact: Study Coordinator +97235307776 | |
| Sourasky Medical Center. ( Site 0382) | Recruiting |
| Tel-Aviv, Tell Abib, Israel, 6423906 | |
| Contact: Study Coordinator +97236973082 | |
| Hadassah Medical Center. Ein Kerem ( Site 0383) | Recruiting |
| Jerusalem, Yerushalayim, Israel, 9112001 | |
| Contact: Study Coordinator +97226777957 | |
| Italy | |
| Istituto Clinico Humanitas Research Hospital ( Site 0432) | Recruiting |
| Rozzano, Milano, Italy, 20089 | |
| Contact: Study Coordinator +390282244080 | |
| IRCCS Policlinico San Donato ( Site 0433) | Recruiting |
| San Donato Milanese, Milano, Italy, 20097 | |
| Contact: Study Coordinator +3902527741 | |
| Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430) | Recruiting |
| Milano, Italy, 20133 | |
| Contact: Study Coordinator +390223903835 | |
| Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429) | Recruiting |
| Modena, Italy, 41125 | |
| Contact: Study Coordinator +300594224383 | |
| Seconda Universita Napoli ( Site 0436) | Completed |
| Napoli, Italy, 80131 | |
| IRCCS Istituto Oncologico Veneto ( Site 0431) | Recruiting |
| Padova, Italy, 35128 | |
| Contact: Study Coordinator +390498215910 | |
| A.O.U. Santa Maria della Misericordia di Udine ( Site 0434) | Recruiting |
| Udine, Italy, 33100 | |
| Contact: Study Coordinator +390432559330 | |
| Japan | |
| Aichi Cancer Center Hospital ( Site 0165) | Active, not recruiting |
| Nagoya, Aichi, Japan, 464-8681 | |
| National Cancer Center Hospital East ( Site 0178) | Active, not recruiting |
| Kashiwa, Chiba, Japan, 277-8577 | |
| National Hospital Organization Shikoku Cancer Center ( Site 0186) | Active, not recruiting |
| Matsuyama, Ehime, Japan, 791-0280 | |
| Hokkaido University Hospital ( Site 0160) | Active, not recruiting |
| Sapporo, Hokkaido, Japan, 060-8648 | |
| Hyogo Cancer Center ( Site 0182) | Active, not recruiting |
| Akashi, Hyogo, Japan, 673-8558 | |
| Kobe University Hospital ( Site 0188) | Completed |
| Kobe, Hyogo, Japan, 650-0017 | |
| Kobe City Medical Center General Hospital ( Site 0181) | Recruiting |
| Kobe, Hyogo, Japan, 650-0047 | |
| Contact: Study Coordinator +81783024321 | |
| Ibaraki Prefectural Central Hospital ( Site 0177) | Active, not recruiting |
| Kasama, Ibaraki, Japan, 309-1793 | |
| Iwate Medical University Hospital ( Site 0184) | Active, not recruiting |
| Shiwa-gun, Iwate, Japan, 028-3695 | |
| St. Marianna University School of Medicine Hospital ( Site 0187) | Active, not recruiting |
| Kawasaki, Kanagawa, Japan, 216-8511 | |
| Kanagawa Cancer Center ( Site 0167) | Active, not recruiting |
| Yokohama, Kanagawa, Japan, 241-8515 | |
| Kansai Medical University Hospital ( Site 0190) | Active, not recruiting |
| Hirakata, Osaka, Japan, 573-1191 | |
| Osaka University Hospital ( Site 0162) | Active, not recruiting |
| Suita, Osaka, Japan, 565-0871 | |
| Osaka Medical College Hospital ( Site 0168) | Active, not recruiting |
| Takatsuki, Osaka, Japan, 569-8686 | |
| Saitama Cancer Center ( Site 0170) | Active, not recruiting |
| Kitaadachi-gun, Saitama, Japan, 362-0806 | |
| Shizuoka Cancer Center Hospital and Research Institute ( Site 0176) | Active, not recruiting |
| Sunto-gun, Shizuoka, Japan, 411-8777 | |
| Chiba Cancer Center ( Site 0180) | Active, not recruiting |
| Chiba, Japan, 260-8717 | |
| National Hospital Organization Kyushu Cancer Center ( Site 0172) | Active, not recruiting |
| Fukuoka, Japan, 811-1395 | |
| Kyushu University Hospital ( Site 0173) | Active, not recruiting |
| Fukuoka, Japan, 812-8582 | |
| Gifu University Hospital ( Site 0166) | Active, not recruiting |
| Gifu, Japan, 501-1194 | |
| Hiroshima City Hiroshima Citizens Hospital ( Site 0171) | Active, not recruiting |
| Hiroshima, Japan, 730-8518 | |
| Kochi Health Sciences Center ( Site 0189) | Active, not recruiting |
| Kochi, Japan, 781-8555 | |
| Kumamoto University Hospital ( Site 0164) | Active, not recruiting |
| Kumamoto, Japan, 860-8556 | |
| Niigata Cancer Center Hospital ( Site 0169) | Active, not recruiting |
| Niigata, Japan, 951-8566 | |
| Osaka International Cancer Institute ( Site 0161) | Active, not recruiting |
| Osaka, Japan, 541-8567 | |
| Osaka General Medical Center ( Site 0159) | Active, not recruiting |
| Osaka, Japan, 558-8558 | |
| National Cancer Center Hospital ( Site 0179) | Active, not recruiting |
| Tokyo, Japan, 104-0045 | |
| Tokyo Metropolitan Komagome Hospital ( Site 0183) | Active, not recruiting |
| Tokyo, Japan, 113-8677 | |
| The Cancer Institute Hospital of JFCR ( Site 0185) | Active, not recruiting |
| Tokyo, Japan, 135-8550 | |
| Toyama Prefectural Central Hospital ( Site 0163) | Active, not recruiting |
| Toyama, Japan, 930-8550 | |
| Korea, Republic of | |
| Chonnam National University Hwasun Hospital ( Site 0083) | Recruiting |
| Hwasun Gun, Jeonranamdo, Korea, Republic of, 58128 | |
| Contact: Study Coordinator +82613797623 | |
| Gachon University Gil Medical Center ( Site 0087) | Recruiting |
| Incheon, Kyonggi-do, Korea, Republic of, 21565 | |
| Contact: Study Coordinator +82324608507 | |
| Seoul National University Bundang Hospital ( Site 0085) | Recruiting |
| Seongnam-si, Kyonggi-do, Korea, Republic of, 13620 | |
| Contact: Study Coordinator +82317877037 | |
| Korea University Anam Hospital ( Site 0084) | Recruiting |
| Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 02841 | |
| Contact: Study Coordinator +8229206082 | |
| Seoul National University Hospital -SNUH- ( Site 0080) | Recruiting |
| Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03080 | |
| Contact: Study Coordinator 82220722236 | |
| Severance Hospital Yonsei University Health System ( Site 0081) | Recruiting |
| Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03722 | |
| Contact: Study Coordinator +82222288132 | |
| Asan Medical Center ( Site 0082) | Recruiting |
| Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505 | |
| Contact: Study Coordinator +82230103230 | |
| Gangnam Severance Hospital ( Site 0088) | Recruiting |
| Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06273 | |
| Contact: Study Coordinator +82220191237 | |
| SMG-SNU BORAMAE Medical Center ( Site 0086) | Recruiting |
| Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 07061 | |
| Contact: Study Coordinator +8228702231 | |
| Kyungpook National University Chilgok Hospital ( Site 0089) | Recruiting |
| Daegu, Taegu-Kwangyokshi, Korea, Republic of, 41404 | |
| Contact: Study Coordinator +82532002114 | |
| Poland | |
| Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358) | Recruiting |
| Wroclaw, Dolnoslaskie, Poland, 51-124 | |
| Contact: Study Coordinator +48606753363 | |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351) | Recruiting |
| Lublin, Lubelskie, Poland, 20-080 | |
| Contact: Study Coordinator +48815344313 | |
| Szpital Uniwersytecki w Krakowie ( Site 0352) | Recruiting |
| Krakow, Malopolskie, Poland, 31-501 | |
| Contact: Study Coordinator +48124248912 | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349) | Recruiting |
| Warszawa, Mazowieckie, Poland, 02-034 | |
| Contact: Study Coordinator +48225462328 | |
| Mazowiecki Szpital Onkologiczny ( Site 0363) | Recruiting |
| Wieliszew, Mazowieckie, Poland, 05-135 | |
| Contact: Study Coordinator +48227661500 | |
| Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353) | Recruiting |
| Koscierzyna, Pomorskie, Poland, 83-400 | |
| Contact: Study Coordinator +48793929449 | |
| Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354) | Completed |
| Bielsko-Biala, Slaskie, Poland, 43-300 | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361) | Recruiting |
| Gliwice, Slaskie, Poland, 44-101 | |
| Contact: Study Coordinator +48322788237 | |
| SPZOZ WSS nr 3 w Rybniku ( Site 0357) | Completed |
| Rybnik, Slaskie, Poland, 44-200 | |
| Russian Federation | |
| Kaluga Regional Clinical Oncology Center ( Site 0345) | Recruiting |
| Kaluga, Kaluzskaja Oblast', Russian Federation, 248007 | |
| Contact: Study Coordinator +79200900576 | |
| National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338) | Recruiting |
| Moscow, Moskva, Russian Federation, 105203 | |
| Contact: Study Coordinator +74956037218 | |
| Blokhin National Medical Oncology ( Site 0494) | Recruiting |
| Moscow, Moskva, Russian Federation, 115478 | |
| Contact: Study Coordinator +74993241004 | |
| SBHI Leningrad Regional Clinical Hospital ( Site 0496) | Recruiting |
| Saint Petersburg, Sankt-Peterburg, Russian Federation, 194291 | |
| Contact: Study Coordinator +78125922529 | |
| Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344) | Recruiting |
| Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758 | |
| Contact: Study Coordinator +79219462123 | |
| Leningrad Regional Oncology Center ( Site 0335) | Completed |
| Saint-Petersburg, Sankt-Peterburg, Russian Federation, 188663 | |
| City clinical oncological dispensary ( Site 0336) | Active, not recruiting |
| Sankt-Petersburg, Sankt-Peterburg, Russian Federation, 198255 | |
| Tomsk Scientific Research Institute of Oncology ( Site 0337) | Recruiting |
| Tomsk, Tomskaya Oblast', Russian Federation, 634028 | |
| Contact: Study Coordinator +73822418091 | |
| Singapore | |
| National University Hospital ( Site 0095) | Recruiting |
| Singapore, Central Singapore, Singapore, 119074 | |
| Contact: Study Coordinator +6567724670 | |
| National Cancer Centre Singapore ( Site 0097) | Recruiting |
| Singapore, Central Singapore, Singapore, 169610 | |
| Contact: Study Coordinator +6564368497 | |
| Oncocare Cancer Centre ( Site 0096) | Completed |
| Singapore, Central Singapore, Singapore, 258499 | |
| Taiwan | |
| Taipei Medical University Shuang Ho Hospital ( Site 0068) | Completed |
| New Taipei, Taiwan, 235 | |
| National Cheng Kung University Hospital ( Site 0067) | Recruiting |
| Tainan, Taiwan, 704 | |
| Contact: Study Coordinator +88662353535 | |
| National Taiwan University Hospital ( Site 0063) | Recruiting |
| Taipei, Taiwan, 10002 | |
| Contact: Study Coordinator +886223123456 | |
| Mackay Memorial Hospital ( Site 0065) | Recruiting |
| Taipei, Taiwan, 104 | |
| Contact: Study Coordinator +886225433535 | |
| Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066) | Recruiting |
| Taipei, Taiwan, 11259 | |
| Contact: Study Coordinator +886228970011 | |
| Chang Gung Medical Foundation. Linkou ( Site 0064) | Recruiting |
| Taoyuan, Taiwan, 333 | |
| Contact: Study Coordinator +88633281200 | |
| United Kingdom | |
| University Hospitals Bristol NHS Foundation Trust ( Site 0407) | Recruiting |
| Bristol, Bristol, City Of, United Kingdom, BS2 8ED | |
| Contact: Study Coordinator +441173427857 | |
| Royal Free London NHS Foundation Trust ( Site 0403) | Completed |
| London, London, City Of, United Kingdom, NW3 2QG | |
| The Royal Marsden Foundation Trust ( Site 0405) | Recruiting |
| London, London, City Of, United Kingdom, SW3 6JJ | |
| Contact: Study Coordinator +442089156196 | |
| Imperial College Healthcare NHS Trust ( Site 0402) | Recruiting |
| London, London, City Of, United Kingdom, W2 1NY | |
| Contact: Study Coordinator +442033113311 | |
| Royal Marsden NHS Foundation Trust ( Site 0400) | Recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Contact: Study Coordinator +442089156196 | |
| Ninewells Hospital and Medical School ( Site 0406) | Recruiting |
| Dundee, United Kingdom, DD1 9SY | |
| Contact: Study Coordinator +441382496685 | |
| The Christie NHS Foundation Trust ( Site 0397) | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Contact: Study Coordinator +441614468342 | |
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT03221426 |
| Other Study ID Numbers: |
3475-585 2016-004408-76 ( EudraCT Number ) MK-3475-585 ( Other Identifier: Merck Protocol Number ) 173786 ( Registry Identifier: JAPIC ) KEYNOTE-585 ( Other Identifier: Merck ) PHRR200226-002534 ( Registry Identifier: PHRR Research Registration ) |
| First Posted: | July 18, 2017 Key Record Dates |
| Last Update Posted: | May 28, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
| URL: | http://engagezone.msd.com/ds_documentation.php |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Programmed Cell Death-1 (PD1, PD-1) Programmed Death-Ligand 1 (PDL1, PD-L1) |
Additional relevant MeSH terms:
|
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Leucovorin Docetaxel Fluorouracil Capecitabine Oxaliplatin Pembrolizumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological Antidotes Protective Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances |