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 : February 15, 2019
|
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 hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), event-free survival (EFS) and pathological complete response (pathCR) rate.
| 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 : | 860 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 : | July 26, 2023 |
| Estimated Study Completion Date : | July 26, 2023 |
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 Name: MK-3475 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
Normal saline solution 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 Safety 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 Name: MK-3475 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® |
|
Placebo Comparator: Placebo+FLOT Safety 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
Normal saline solution 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) [ 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) [ 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 Response Criteria in Solid Tumors version 1.1 (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 [ 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 pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
- Adverse Events (AEs) [ 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 number of participants who experience at least one AE will be presented.
- Study Treatment Discontinuations Due to AEs [ 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 number of participants who discontinue study treatment due to an AE will be presented.
Secondary Outcome Measures :
- Disease-free Survival (DFS) [ 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.
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 |
Hide Study Locations
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) | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Study Coordinator 773-702-7596 | |
| United States, New York | |
| Roswell Park Cancer Institute ( Site 0001) | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Study Coordinator 877-275-7724 | |
| 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) | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Study Coordinator 646-888-4183 | |
| 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) | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Study Coordinator 703-280-5390 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center ( Site 0006) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Study Coordinator 215-214-4283 | |
| Temple University Hospital ( Site 0026) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Study Coordinator 215-214-4283 | |
| 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) | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| Contact: Study Coordinator 703-280-5390 | |
| Belgium | |
| Institut Jules Bordet ( Site 0480) | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Study Coordinator +3225417209 | |
| Hopital Erasme ULB ( Site 0484) | Recruiting |
| Brussels, Belgium, 1070 | |
| Contact: Study Coordinator +3225553714 | |
| UCL Saint Luc ( Site 0479) | Recruiting |
| Bruxelles, Belgium, 1200 | |
| Contact: Study Coordinator +3227641274 | |
| Grand Hopital de Charleroi ( Site 0478) | Recruiting |
| Charleroi, Belgium, 6000 | |
| Contact: Study Coordinator +3271104730 | |
| AZ Groeninge ( Site 0481) | Recruiting |
| Kortrijk, Belgium, 8500 | |
| Contact: Study Coordinator +3256633338 | |
| UZ Leuven ( Site 0483) | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Study Coordinator +3216344218 | |
| CHU - Sart Tilman ( Site 0482) | Recruiting |
| Liege, Belgium, 4000 | |
| Contact: Study Coordinator +3243667256 | |
| CHU UCL Namur Site de Godinne ( Site 0485) | Recruiting |
| Yvoir, Belgium, 5530 | |
| Contact: Study Coordinator +3281423858 | |
| Brazil | |
| Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307) | Recruiting |
| Rio de Janeiro, RJ, Brazil, 20230-130 | |
| Contact: Study Coordinator +552132076564 | |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308) | Recruiting |
| Porto Alegre, RS, 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, SP, Brazil, 14784-400 | |
| Contact: Study Coordinator +551733216637 | |
| Instituto do Cancer de Sao Paulo - ICESP ( Site 0305) | Recruiting |
| Sao Paulo, SP, Brazil, 01246-000 | |
| Contact: Study Coordinator +551138932615 | |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0304) | Recruiting |
| Sao Jose Rio Preto, Brazil, 15090-000 | |
| Contact: Study Coordinator +551732015054 | |
| Canada, Alberta | |
| Cross Cancer Institute ( Site 0033) | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Study Coordinator 7804328513 | |
| 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) | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Study Coordinator 4164804270 | |
| Canada, Quebec | |
| CISSS de la Monteregie-Centre ( Site 0039) | Recruiting |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Contact: Study Coordinator 4504665000x2696 | |
| 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) | Recruiting |
| Quebec, Canada, G1R 2J6 | |
| Contact: Study Coordinator 4185254444 | |
| Chile | |
| Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299) | Recruiting |
| Rancagua, Chile, 2820000 | |
| Contact: Study Coordinator +56998 9000000 | |
| Fundacion Arturo Lopez Perez FALP ( Site 0286) | Recruiting |
| Santiago, Chile, 7500921 | |
| Contact: Study Coordinator +56224457254 | |
| Pontificia Universidad Catolica de Chile ( Site 0285) | Recruiting |
| Santiago, Chile, 8330032 | |
| Contact: Study Coordinator +56222472327 | |
| Hospital Clinico Universidad de Chile ( Site 0287) | Completed |
| Santiago, Chile, 8380456 | |
| Instituto Clinico del Sur. ICOS ( Site 0290) | Recruiting |
| Temuco, Chile, 4810469 | |
| Contact: Study Coordinator +56994443272 | |
| France | |
| CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474) | Recruiting |
| Brest, France, 29200 | |
| Contact: Study Coordinator +33298223428 | |
| CHRU Lille - Hopital Claude Huriez ( Site 0461) | Recruiting |
| Lille, France, 59037 | |
| Contact: Study Coordinator +33320444407 | |
| Hopital Prive Jean Mermoz ( Site 0462) | Recruiting |
| Lyon, France, 69008 | |
| Contact: Study Coordinator +33437538764 | |
| Institut Paoli Calmettes ( Site 0472) | Recruiting |
| Marseille, France, 13009 | |
| Contact: Study Coordinator +33491223537 | |
| Institut du Cancer de Montpellier ( Site 0473) | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Study Coordinator +33467613136 | |
| 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 | |
| CHU Poitiers - Pole Regional de Cancerologie ( Site 0467) | Recruiting |
| Poitiers, France, 86021 | |
| Contact: Study Coordinator +33549444951 | |
| Centre Eugene Marquis ( Site 0466) | Recruiting |
| Rennes, France, 35042 | |
| Contact: Study Coordinator +33299253159 | |
| Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469) | Recruiting |
| Saint Herblain, France, 44805 | |
| Contact: Study Coordinator +33240679900 | |
| CHU Toulouse - Hopital Rangueil ( Site 0470) | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Study Coordinator +33561322142 | |
| Germany | |
| Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448) | Recruiting |
| Dresden, Germany, 01307 | |
| Contact: Study Coordinator +493514584794 | |
| Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445) | Recruiting |
| Essen, Germany, 45136 | |
| Contact: Study Coordinator +4920117424524 | |
| Klinikum Esslingen GmbH ( Site 0453) | Recruiting |
| Esslingen, Germany, 73730 | |
| Contact: Study Coordinator +4971131032451 | |
| Universitaetsklinikum Freiburg ( Site 0450) | Recruiting |
| Freiburg, Germany, 79106 | |
| Contact: Study Coordinator +4976127028080 | |
| Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454) | Recruiting |
| Hamburg, Germany, 20249 | |
| Contact: Study Coordinator +49404602001 | |
| Medizinische Hochschule Hannover ( Site 0449) | Recruiting |
| Hannover, Germany, 30625 | |
| Contact: Study Coordinator +495115326727 | |
| Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455) | Recruiting |
| Mainz, Germany, 55131 | |
| Contact: Study Coordinator +496131176076 | |
| Klinikum der Universitaet in Muenchen ( Site 0446) | Recruiting |
| Muenchen, Germany, 81377 | |
| Contact: Study Coordinator +498944000 | |
| Israel | |
| Soroka University M.C ( Site 0385) | Recruiting |
| Beer Sheva, Israel, 8410101 | |
| Contact: Study Coordinator +972864000798 | |
| Rambam Health Care Campus ( Site 0381) | Recruiting |
| Haifa, Israel, 3109601 | |
| Contact: Study Coordinator +97247776731 | |
| Hadassah Medical Center ( Site 0383) | Recruiting |
| Jerusalem, Israel, 9112001 | |
| Contact: Study Coordinator +97226777957 | |
| Meir medical center ( Site 0386) | Recruiting |
| Kfar Saba, Israel, 4428164 | |
| Contact: Study Coordinator +97297472393 | |
| Rabin-Medical Center ( Site 0384) | Recruiting |
| Petah Tikva, Israel, 4963211 | |
| Contact: Study Coordinator +97239378081 | |
| Sheba Medical center ( Site 0387) | Recruiting |
| Ramat Gan, Israel, 5265601 | |
| Contact: Study Coordinator +97235307776 | |
| Sourasky Medical Center. ( Site 0382) | Recruiting |
| Tel-Aviv, Israel, 6423906 | |
| Contact: Study Coordinator +97236973082 | |
| Italy | |
| Istituto Clinico Humanitas Research Hospital ( Site 0432) | Recruiting |
| Rozzano, Milano, Italy, 20089 | |
| Contact: Study Coordinator +390282244080 | |
| Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429) | Recruiting |
| Modena, MO, Italy, 41125 | |
| Contact: Study Coordinator +300594224383 | |
| Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430) | Recruiting |
| Milano, Italy, 20133 | |
| Contact: Study Coordinator +390223903835 | |
| Seconda Universita Napoli ( Site 0436) | Recruiting |
| Napoli, Italy, 80131 | |
| Contact: Study Coordinator +390815666713 | |
| IRCCS Istituto Oncologico Veneto ( Site 0431) | Recruiting |
| Padova, Italy, 35128 | |
| Contact: Study Coordinator +390498215910 | |
| IRCCS Policlinico San Donato ( Site 0433) | Recruiting |
| San Donato Milanese, Italy, 20097 | |
| Contact: Study Coordinator +3902527741 | |
| 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) | Recruiting |
| Nagoya, Aichi, Japan, 464-8681 | |
| Contact: Study Coordinator +81527626111 | |
| National Cancer Center Hospital East ( Site 0178) | Recruiting |
| Kashiwa, Chiba, Japan, 277-8577 | |
| Contact: Study Coordinator +81471331111 | |
| National Hospital Organization Shikoku Cancer Center ( Site 0186) | Recruiting |
| Matsuyama, Ehime, Japan, 791-0280 | |
| Contact: Study Coordinator +81899991111 | |
| Hokkaido University Hospital ( Site 0160) | Recruiting |
| Sapporo, Hokkaido, Japan, 060-8648 | |
| Contact: Study Coordinator +81117161161 | |
| Hyogo Cancer Center ( Site 0182) | Recruiting |
| Akashi, Hyogo, Japan, 673-8558 | |
| Contact: Study Coordinator +81789291151 | |
| Kobe University Hospital ( Site 0188) | Recruiting |
| Kobe, Hyogo, Japan, 650-0017 | |
| Contact: Study Coordinator +81783825111 | |
| Kobe City Medical Center General Hospital ( Site 0181) | Recruiting |
| Kobe, Hyogo, Japan, 650-0047 | |
| Contact: Study Coordinator +81783024321 | |
| Ibaraki Prefectural Central Hospital ( Site 0177) | Recruiting |
| Kasama, Ibaraki, Japan, 309-1793 | |
| Contact: Study Coordinator +81296771121 | |
| Iwate Medical University Hospital ( Site 0184) | Recruiting |
| Morioka, Iwate, Japan, 020-8505 | |
| Contact: Study Coordinator +81196515111 | |
| St. Marianna University School of Medicine Hospital ( Site 0187) | Recruiting |
| Kawasaki, Kanagawa, Japan, 216-8511 | |
| Contact: Study Coordinator +81449778111 | |
| Kanagawa Cancer Center ( Site 0167) | Recruiting |
| Yokohama, Kanagawa, Japan, 241-8515 | |
| Contact: Study Coordinator +81455202222 | |
| Kansai Medical University Hospital ( Site 0190) | Recruiting |
| Hirakata, Osaka, Japan, 573-1191 | |
| Contact: Study Coordinator +81728040101 | |
| Osaka University Hospital ( Site 0162) | Recruiting |
| Suita, Osaka, Japan, 565-0871 | |
| Contact: Study Coordinator +81668795111 | |
| Osaka Medical College Hospital ( Site 0168) | Recruiting |
| Takatsuki, Osaka, Japan, 569-8686 | |
| Contact: Study Coordinator +81726831221 | |
| Saitama Cancer Center ( Site 0170) | Recruiting |
| Kitaadachi-gun, Saitama, Japan, 362-0806 | |
| Contact: Study Coordinator +81487221111 | |
| Shizuoka Cancer Center Hospital and Research Institute ( Site 0176) | Recruiting |
| Sunto-gun, Shizuoka, Japan, 411-8777 | |
| Contact: Study Coordinator +81559895222 | |
| Chiba Cancer Center ( Site 0180) | Recruiting |
| Chiba, Japan, 260-8717 | |
| Contact: Study Coordinator +81432645431 | |
| National Hospital Organization Kyushu Cancer Center ( Site 0172) | Recruiting |
| Fukuoka, Japan, 811-1395 | |
| Contact: Study Coordinator +81925413231 | |
| Kyushu University Hospital ( Site 0173) | Recruiting |
| Fukuoka, Japan, 812-8582 | |
| Contact: Study Coordinator +81926411151 | |
| Gifu University Hospital ( Site 0166) | Recruiting |
| Gifu, Japan, 501-1194 | |
| Contact: Study Coordinator +81582306000 | |
| Hiroshima City Hiroshima Citizens Hospital ( Site 0171) | Recruiting |
| Hiroshima, Japan, 730-8518 | |
| Contact: Study Coordinator +81822212291 | |
| Kochi Health Sciences Center ( Site 0189) | Recruiting |
| Kochi, Japan, 781-8555 | |
| Contact: Study Coordinator +81888373000 | |
| Kumamoto University Hospital ( Site 0164) | Recruiting |
| Kumamoto, Japan, 860-8556 | |
| Contact: Study Coordinator +81963442111 | |
| Niigata Cancer Center Hospital ( Site 0169) | Recruiting |
| Niigata, Japan, 951-8566 | |
| Contact: Study Coordinator +81252665111 | |
| Osaka International Cancer Institute ( Site 0161) | Recruiting |
| Osaka, Japan, 541-8567 | |
| Contact: Study Coordinator +81669451181 | |
| Osaka General Medical Center ( Site 0159) | Recruiting |
| Osaka, Japan, 558-8558 | |
| Contact: Study Coordinator +81666921201 | |
| National Cancer Center Hospital ( Site 0179) | Recruiting |
| Tokyo, Japan, 104-0045 | |
| Contact: Study Coordinator +81335422511 | |
| Tokyo Metropolitan Komagome Hospital ( Site 0183) | Recruiting |
| Tokyo, Japan, 113-8677 | |
| Contact: Study Coordinator +81338232101 | |
| The Cancer Institute Hospital of JFCR ( Site 0185) | Recruiting |
| Tokyo, Japan, 135-8550 | |
| Contact: Study Coordinator +81335200111 | |
| Toyama Prefectural Central Hospital ( Site 0163) | Recruiting |
| Toyama, Japan, 930-8550 | |
| Contact: Study Coordinator +81764241531 | |
| Korea, Republic of | |
| Seoul National University Bundang Hospital ( Site 0085) | Recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620 | |
| Contact: Study Coordinator +82317877037 | |
| Chonnam National University Hwasun Hospital ( Site 0083) | Recruiting |
| Hwasun Gun, Jeollanam Do, Korea, Republic of, 58128 | |
| Contact: Study Coordinator +82613797623 | |
| Korea University Anam Hospital ( Site 0084) | Recruiting |
| Seoul, Korea, Republic of, 02841 | |
| Contact: Study Coordinator +8229206082 | |
| Seoul National University Hospital -SNUH- ( Site 0080) | Recruiting |
| Seoul, Korea, Republic of, 03080 | |
| Contact: Study Coordinator 82220722236 | |
| Severance Hospital Yonsei University Health System ( Site 0081) | Recruiting |
| Seoul, Korea, Republic of, 03722 | |
| Contact: Study Coordinator +82222288132 | |
| Asan Medical Center ( Site 0082) | Recruiting |
| Seoul, Korea, Republic of, 05505 | |
| Contact: Study Coordinator +82230103230 | |
| SMG-SNU BORAMAE Medical Center ( Site 0086) | Recruiting |
| Seoul, Korea, Republic of, 07061 | |
| Contact: Study Coordinator +8228702231 | |
| Poland | |
| 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, Poland, 43-300 | |
| Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 0361) | Recruiting |
| Gliwice, Poland, 44-101 | |
| Contact: Study Coordinator +48322788237 | |
| Szpital Uniwersytecki w Krakowie ( Site 0352) | Recruiting |
| Krakow, Poland, 31-531 | |
| Contact: Study Coordinator +48124248912 | |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351) | Recruiting |
| Lublin, Poland, 20-081 | |
| Contact: Study Coordinator +48815344313 | |
| SPZOZ WSS nr 3 w Rybniku ( Site 0357) | Recruiting |
| Rybnik, Poland, 44-200 | |
| Contact: Study Coordinator +48603759221 | |
| Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0349) | Recruiting |
| Warszawa, Poland, 02-034 | |
| Contact: Study Coordinator +48225462328 | |
| Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358) | Recruiting |
| Wroclaw, Poland, 51-124 | |
| Contact: Study Coordinator +48606753363 | |
| Russian Federation | |
| Kaluga Regional Clinical Oncology Center ( Site 0345) | Recruiting |
| Kaluga, Russian Federation, 248007 | |
| Contact: Study Coordinator +79200900576 | |
| National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338) | Recruiting |
| Moscow, Russian Federation, 105203 | |
| Contact: Study Coordinator +74956037218 | |
| Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344) | Recruiting |
| Saint Petersburg, Russian Federation, 197758 | |
| Contact: Study Coordinator +79219462123 | |
| Leningrad Regional Oncology Center ( Site 0335) | Recruiting |
| Saint-Petersburg, Russian Federation, 188663 | |
| Contact: Study Coordinator +79219650996 | |
| City clinical oncological dispensary ( Site 0336) | Recruiting |
| Sankt-Petersburg, Russian Federation, 198255 | |
| Contact: Study Coordinator +78127569923 | |
| Tomsk Scientific Research Institute of Oncology ( Site 0337) | Recruiting |
| Tomsk, Russian Federation, 634028 | |
| Contact: Study Coordinator +73822418091 | |
| Singapore | |
| National University Hospital ( Site 0095) | Recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Study Coordinator +6567724670 | |
| National Cancer Centre Singapore ( Site 0097) | Recruiting |
| Singapore, Singapore, 169610 | |
| Contact: Study Coordinator +6564368497 | |
| Oncocare Cancer Centre ( Site 0096) | Recruiting |
| Singapore, Singapore, 258499 | |
| Contact: Study Coordinator +6567723905 | |
| Taiwan | |
| Taipei Medical University Shuang Ho Hospital ( Site 0068) | Recruiting |
| New Taipei, Taiwan, 23561 | |
| Contact: Study Coordinator 886222490088 | |
| National Cheng Kung University Hospital ( Site 0067) | Recruiting |
| Tainan, Taiwan, 70403 | |
| Contact: Study Coordinator +88662353535 | |
| National Taiwan University Hospital ( Site 0063) | Recruiting |
| Taipei, Taiwan, 100 | |
| 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 | |
| Royal Marsden NHS Foundation Trust ( Site 0400) | Recruiting |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Contact: Study Coordinator +442089156196 | |
| Imperial College Healthcare NHS Trust ( Site 0402) | Recruiting |
| London, UK, United Kingdom, W2 1NY | |
| Contact: Study Coordinator +442033113311 | |
| University Hospitals Bristol NHS Foundation Trust ( Site 0407) | Recruiting |
| Bristol, United Kingdom, BS2 8ED | |
| Contact: Study Coordinator +441173427857 | |
| Ninewells Hospital and Medical School ( Site 0406) | Recruiting |
| Dundee, United Kingdom, DD1 9SY | |
| Contact: Study Coordinator +441382496685 | |
| Royal Free London NHS Foundation Trust ( Site 0403) | Recruiting |
| London, United Kingdom, NW3 2QG | |
| Contact: Study Coordinator +44207794050032325 | |
| The Royal Marsden Foundation Trust ( Site 0405) | Recruiting |
| London, United Kingdom, SW3 6JJ | |
| Contact: Study Coordinator +442089156196 | |
| The Christie NHS Foundation Trust ( Site 0397) | Active, not recruiting |
| Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT03221426 History of Changes |
| Other Study ID Numbers: |
3475-585 2016-004408-76 ( EudraCT Number ) MK-3475-585 ( Other Identifier: Merck Protocol Number ) 173786 ( Registry Identifier: JAPIC ) |
| First Posted: | July 18, 2017 Key Record Dates |
| Last Update Posted: | February 15, 2019 |
| Last Verified: | February 2019 |
| 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.:
|
PD1 PD-1 PDL1 PD-L1 |
Additional relevant MeSH terms:
|
Adenocarcinoma Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Pharmaceutical Solutions Docetaxel Oxaliplatin |
Pembrolizumab Cisplatin Capecitabine Fluorouracil Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |