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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 : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Cancer of the Stomach Esophagogastric Junction Biological: BMS-986213 Biological: Nivolumab Drug: XELOX Drug: FOLFOX Drug: SOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 27, 2020
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
 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
Experimental: Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
 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


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 22 months ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Up to 5 years ]
  4. Incidence of death [ Time Frame: Up to 5 years ]
  5. Incidence of laboratory abnormalities [ Time Frame: Up to 5 years ]
  6. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
  7. Overall survival (OS) [ Time Frame: Up to 5 years ]
  8. Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]

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

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 and either 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 and either 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

Contacts and Locations
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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): NCT03662659


Contacts
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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 #.

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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03662659     History of Changes
Other Study ID Numbers: CA224-060
2018-001069-18 ( EudraCT Number )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents