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An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

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ClinicalTrials.gov Identifier: NCT03662659
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date December 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Objective Response Rate (ORR) [ Time Frame: Up to 22 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03662659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
  • Incidence of death [ Time Frame: Up to 5 years ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]
  • Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  • Overall survival (OS) [ Time Frame: Up to 5 years ]
  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Official Title  ICMJE A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Brief Summary The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Cancer of the Stomach
  • Esophagogastric Junction
Intervention  ICMJE
  • Biological: BMS-986213
    Relatlimab + Nivolumab specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: XELOX
    Oxaliplatin + capecitabine
  • Drug: FOLFOX
    Oxaliplatin + leucovorin + fluorouracil
  • Drug: SOX
    Oxaliplatin + tegafur/gimeracil/oteracil potassium
Study Arms  ICMJE
  • Experimental: BMS-986213 + investigator's choice chemotherapy
    BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
    Interventions:
    • Biological: BMS-986213
    • Biological: Nivolumab
    • Drug: XELOX
    • Drug: FOLFOX
    • Drug: SOX
  • Experimental: Nivolumab + investigator's choice chemotherapy
    Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
    Interventions:
    • Biological: Nivolumab
    • Drug: XELOX
    • Drug: FOLFOX
    • Drug: SOX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date December 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Histologically- or cytologically-confirmed diagnosis of unresectable, locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
  • No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable, locally advanced, or metastatic GC or GEJ adenocarcinoma
  • Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

  • Participants with HER2 positive status
  • Participants with known untreated central nervous system (CNS) metastases
  • Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Chile,   Czechia,   France,   Germany,   Norway,   Poland,   Puerto Rico,   Singapore,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662659
Other Study ID Numbers  ICMJE CA224-060
2018-001069-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP