Trial record 1 of 1 for:
CA224-060
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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 7, 2018
Last Update Posted : August 27, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
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Biological: BMS-986213
Relatlimab + Nivolumab specified dose on specified days Biological: Nivolumab Specified dose on specified days
Other Names:
Drug: XELOX Oxaliplatin + capecitabine Drug: FOLFOX Oxaliplatin + leucovorin + fluorouracil Drug: SOX Oxaliplatin + tegafur/gimeracil/oteracil potassium |
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Experimental: Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
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Biological: Nivolumab
Specified dose on specified days
Other Names:
Drug: XELOX Oxaliplatin + capecitabine Drug: FOLFOX Oxaliplatin + leucovorin + fluorouracil Drug: SOX Oxaliplatin + tegafur/gimeracil/oteracil potassium |
Primary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: Up to 22 months ]
Secondary Outcome Measures :
- 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 ]
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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
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
Locations
Show 78 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03662659 |
| Other Study ID Numbers: |
CA224-060 2018-001069-18 ( EudraCT Number ) |
| First Posted: | September 7, 2018 Key Record Dates |
| Last Update Posted: | August 27, 2020 |
| Last Verified: | August 2020 |
| 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 |