Gastric or Gastroesophageal Junction Adenocarcinoma MedDRA version: 20.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 294 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: - Participants with HER2 positive status - Participants with known untreated central nervous system (CNS) metastases - Uncontrolled or significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare objective response rate (ORR) of BMS-986213 in combination with chemotherapy, with ORR of nivolumab in combination with chemotherapy, by BICR, in randomized participants with untreated, locally advanced, unresectable or metastatic LAG-3 positive GC or GEJ adenocarcinoma.;Secondary Objective: - To assess overall safety&tolerability of BMS-986213+chemo vs. nivo+chemo in treated participants with advanced or metastatic GC or GEJ cancer -To compare ORR of BMS-986213+chemo, with ORR of nivo+chemo in participants with (i) untreated, locally advanced, unresectable or metastatic LAG-3 pos GC or GEJ adenocarcinoma, (i) advanced or metastatic LAG-3 neg GC or GEJ adenocarcinoma,and overall (Lag-3 pos and neg) -To estimate DOR of BMS-986213+chemo and DOR of nivo+chemo in participants with (i) advanced or metastatic LAG-3 pos GC or GEJ adenocarcinoma (i) advanced or metastatic LAG-3 neg GC or GEJ adenocarcinoma,and the overall population -In participants with untreated,locally advanced,unresectable or metastatic GC or GEJ adenocarcinoma a) in the LAG-3 pos, b) in the neg groups and c) overall to assess (i) the difference in the OS of BMS-986213+chemo and OS of Nivo+chemo, (i) the difference in the PFS of BMS-986213+chemo and PFS of Nivo+chemo ;Primary end point(s): Objective Response Rate (ORR);Timepoint(s) of evaluation of this end point: Up to 22 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a/ Incidence of Adverse Events (AEs) b/ Incidence of Serious Adverse Events (SAEs) c/ Incidence of AEs leading to discontinuation d/ Incidence of death e/ Incidence of laboratory abnormalities f/ Duration of Response (DOR) g/ Overall survival (OS) h/ Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: a/ Up to 5 years b/ Up to 5 years c/ Up to 5 years d/ Up to 5 years e/ Up to 5 years f/ Up to 5 years g/ Up to 5 years h/ Up to 5 years | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Chile, Czech Republic, France, Germany, Italy, Norway, Poland, Singapore, Spain, United Kingdom, United States
Contacts
Public ContactHead of the GCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed