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Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02494583
First received: July 8, 2015
Last updated: May 8, 2017
Last verified: May 2017
  Purpose
This is a study of pembrolizumab (MK-3475) as first-line treatment for participants with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants will be randomly assigned to one of the 3 treatment arms of the study: pembrolizumab as monotherapy, or pembrolizumab + cisplatin + 5-fluorouracil (5-FU) or capecitabine, or placebo + cisplatin + 5-FU or capecitabine. The primary study hypotheses are that pembrolizumab in combination with chemotherapy is superior to chemotherapy alone in terms of Progression-free Survival (PFS) and Overall Survival (OS) and that pembrolizumab monotherapy is as good as or better than chemotherapy alone in terms of OS.

Condition Intervention Phase
Gastric Adenocarcinoma Biological: pembrolizumab Drug: cisplatin Drug: 5-FU Drug: capecitabine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Blinded Independent Central Radiologists' (BICR) Review in Participants Treated with Pembrolizumab Combination Therapy Versus Chemotherapy Alone [ Time Frame: Up to 44 months ]
  • Overall Survival (OS) [ Time Frame: Up to 44 months ]

Secondary Outcome Measures:
  • Overall Response Rate (ORR) per RECIST 1.1 by BICR Review [ Time Frame: Up to 44 months ]
  • Duration of Response (DOR) per RECIST 1.1 by BICR Review [ Time Frame: Up to 44 months ]
  • PFS per RECIST 1.1 by BICR Review in Participants Treated with Pembrolizumab Monotherapy [ Time Frame: Up to 44 months ]
  • Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Core 30-question (C30) Score [ Time Frame: Baseline and Cycles 1, 2, 3, 4, 5 and every 2 cycles thereafter for up to a year or until end of treatment, (whichever comes first) and 30 days post-treatment (Up to 13 months) ]
  • Change from Baseline in EORTC QLQ Module for Gastric Cancer (STO22) Score [ Time Frame: Baseline and Cycles 1, 2, 3, 4, 5 and every 2 cycles thereafter for up to a year or until end of treatment, (whichever comes first) and 30 days post-treatment (Up to 13 months) ]

Estimated Enrollment: 750
Actual Study Start Date: July 31, 2015
Estimated Study Completion Date: June 6, 2020
Estimated Primary Completion Date: February 5, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab monotherapy
Participants receive pembrolizumab 200 mg, intravenously (IV) on Day 1 of each 3 week cycle (Q3W)
Biological: pembrolizumab
IV infusion
Other Name: MK-3475
Experimental: Pembrolizumab + cisplatin + 5-FU
Participants receive pembrolizumab 200 mg Q3W + cisplatin 80 mg/m^2 Q3W + 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 twice a day (BID) on Days 1-14 Q3W may be substituted for 5-FU per local guidelines.
Biological: pembrolizumab
IV infusion
Other Name: MK-3475
Drug: cisplatin
IV infusion
Drug: 5-FU
IV infusion
Drug: capecitabine
oral tablet
Active Comparator: Placebo + cisplatin + 5-FU
Participants receive placebo, IV, Q3W + cisplatin 80 mg/m^2 Q3W + 5-FU 800 mg/m^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m^2 BID on Days 1-14 Q3W may be substituted for 5-FU per local guidelines.
Drug: cisplatin
IV infusion
Drug: 5-FU
IV infusion
Drug: capecitabine
oral tablet

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to first dose of study medication
  • Have histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
  • HER2/neu protein negative and programmed cell death ligand 1 (PD-L1)-positive
  • Have measurable disease
  • Female participants of childbearing potential must be willing to use adequate contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
  • Male participants of childbearing potential should agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication
  • Adequate organ function

Exclusion Criteria:

  • Squamous cell or undifferentiated gastric cancer
  • Previous therapy for locally advanced, unresectable or metastatic gastric/GEJ cancer. Participant may have received prior neoadjuvant or adjuvant therapy as long as it was completed at least 6 months prior to randomization
  • Major surgery, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment.
  • Radiotherapy within 14 days of randomization
  • Known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic treatment in past 2 years
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
  • History of non-infectious pneumonitis that required steroids or current pneumonitis
  • Active infection requiring systemic therapy
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study medication
  • Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, or anti-PD-L2 agent
  • Known history of human immunodeficiency virus (HIV)
  • Known active Hepatitis B or C
  • Currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study medication
  • Received a live vaccine within 30 days of planned start of study medication
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02494583

  Show 62 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02494583     History of Changes
Other Study ID Numbers: 3475-062
2015-000972-88 ( EudraCT Number )
163187 ( Registry Identifier: JAPIC-CTI )
Study First Received: July 8, 2015
Last Updated: May 8, 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Gastric carcinoma
Gastric cancer
Gastroesophageal junction cancer
Gastroesophageal junction carcinoma
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Pembrolizumab
Cisplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 26, 2017