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A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02370498
First received: February 23, 2015
Last updated: November 24, 2016
Last verified: November 2016
  Purpose
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab prolongs progression free survival (PFS) and overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

Condition Intervention Phase
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Biological: pembroliziumab
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine

Resource links provided by NLM:


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

Primary Outcome Measures:
  • PFS in PD-L1-positive Participants by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • OS in PD-L1-positive Participants [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS for All Participants by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • OS in All Participants [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • PFS by Investigator Assessment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • PFS Using Immune-related Response Assessment by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Time to Tumor Progression (TTP) by Investigator Assessment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • TTP Using Immune-response Related Assessment by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall Response Rate (ORR) by Investigator Assessment [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • ORR Using Immune-related Response Assessment by Central Radiology Review [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: May 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years)
Biological: pembroliziumab
Active Comparator: Paclitaxel
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle.
Drug: paclitaxel

  Eligibility

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

Inclusion Criteria:

  • Have histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
  • Confirmed metastatic or locally advanced, unresectable disease (by CT scan or clinical evidence)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine doublet
  • Willing to provide tumor tissue for PD-L1 biomarker analysis (new or archived specimens with agreement of Sponsor)
  • HER-2/neu status known and participants with HER2/neu positive tumors show documentation of disease progression on treatment containing trastuzumab
  • Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel.
  • Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel.
  • Adequate organ function

Exclusion Criteria:

  • Currently participating and receiving study therapy, or participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of medication
  • Squamous cell or undifferentiated gastric cancer
  • Active autoimmune disease that has required systemic treatment in past 2 years (replacement therapy is not considered a form of systemic treatment
  • 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
  • Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent or surgery
  • 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, or in situ cervical cancer that has undergone potentially curative therapy)
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • History or evidence of interstitial lung disease or active noninfectious pneumonitis
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of pembrolizumab or through 180 days after the last dose of paclitaxel.
  • Prior immunotherapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or previously participated in Merck pembrolizumab (MK-3475) clinical trial
  • Known history of human immunodeficiency virus (HIV)
  • Known active Hepatitis B or Hepatitis C
  • Live vaccine within 30 days of planned start of study therapy
  • Known allergy or hypersensitivity to paclitaxel or any components used in the paclitaxel preparation or other contraindication for taxane therapy
  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: NCT02370498

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02370498     History of Changes
Other Study ID Numbers: 3475-061  2014-005241-45  152988 
Study First Received: February 23, 2015
Last Updated: November 24, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Gastric cancer
Gastroesophageal junction cancer

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Pembrolizumab
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016