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An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03704077
Recruitment Status : Terminated (Replaced it with another clinical trial)
First Posted : October 12, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

Condition or disease Intervention/treatment Phase
Gastric Cancer Cancer of the Stomach Stomach Cancer Gastroesophageal Junction Biological: Relatlimab + Nivolumab Biological: Nivolumab Drug: Paclitaxel Drug: Ramucirumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma
Actual Study Start Date : May 17, 2019
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : May 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Cohort A: relatlimab + nivolumab + paclitaxel Biological: Relatlimab + Nivolumab
Specified dose on specified days
Other Name: BMS-986213

Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Drug: Paclitaxel
Specified dose on specified days
Other Names:
  • Taxol
  • Onxal

Experimental: Cohort A: nivolumab + paclitaxel Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Drug: Paclitaxel
Specified dose on specified days
Other Names:
  • Taxol
  • Onxal

Active Comparator: Cohort A: ramucirumab + paclitaxel
Standard-of-care
Drug: Paclitaxel
Specified dose on specified days
Other Names:
  • Taxol
  • Onxal

Drug: Ramucirumab
Specified dose on specified days
Other Name: Cyramza

Experimental: Cohort B: relatlimab + nivolumab Biological: Relatlimab + Nivolumab
Specified dose on specified days
Other Name: BMS-986213

Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Active Comparator: Cohort B: nivolumab
Standard-of-care
Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo

Experimental: Cohort C: relatlimab + nivolumab Biological: Relatlimab + Nivolumab
Specified dose on specified days
Other Name: BMS-986213

Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Approximately 31 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Approximately 5 years ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 5 years ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
  4. Incidence of deaths [ Time Frame: Approximately 5 years ]
  5. Incidence of laboratory abnormalities [ Time Frame: Approximately 5 years ]
  6. ORR [ Time Frame: Approximately 5 years ]
    Cohort A1

  7. Duration of response (DOR) [ Time Frame: Approximately 5 years ]
  8. Progression free survival (PFS) [ Time Frame: Approximately 5 years ]
  9. Overall survival (OS) [ Time Frame: Approximately 5 years ]


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.


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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:

  • Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
  • Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
  • Available tumor tissue for biomarker analysis

Exclusion Criteria:

  • Must not have squamous cell or undifferentiated GC or GEJ
  • Untreated known central nervous system (CNS) metastases
  • Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply


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): NCT03704077


  Show 84 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03704077     History of Changes
Other Study ID Numbers: CA224-061
2018-001070-20 ( EudraCT Number )
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

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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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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
Paclitaxel
Albumin-Bound Paclitaxel
Nivolumab
Ramucirumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological