An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
- Conditions
- Gastric CancerCancer of the StomachEsophagogastric Junction
- Interventions
- Biological: BMS-986213Biological: NivolumabDrug: XELOXDrug: FOLFOXDrug: SOX
- Registration Number
- NCT03662659
- Lead Sponsor
- Bristol-Myers Squibb
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986213 + investigator's choice chemotherapy SOX BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX BMS-986213 + investigator's choice chemotherapy XELOX BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX BMS-986213 + investigator's choice chemotherapy BMS-986213 BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX BMS-986213 + investigator's choice chemotherapy Nivolumab BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX BMS-986213 + investigator's choice chemotherapy FOLFOX BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX Nivolumab + investigator's choice chemotherapy XELOX Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX Nivolumab + investigator's choice chemotherapy Nivolumab Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX Nivolumab + investigator's choice chemotherapy FOLFOX Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX Nivolumab + investigator's choice chemotherapy SOX Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
- Primary Outcome Measures
Name Time Method BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants Up to 25 months The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to 25 months Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
Overall Survival (OS) Up to 25 months Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
Progression-Free Survival (PFS) Up to 25 months Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.
Number of Deaths Up to 25 months Number of deaths in each arm to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
Number of Participants With Adverse Events (AEs) From first dose to 30 days post last dose (Up to 23 months) Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
Number of Participants With Laboratory Abnormalities in Specific Liver Tests From first dose to up to 30 days post last dose (Up to 23 months) Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
* ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN
* Total bilirubin \> 2 x ULN
* ALP \> 1.5 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 1.5 x ULN
* Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN
* Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULNDuration of Response (DOR) Up to 25 months Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented response (complete response or partial response) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests From first dose to up to 30 days post last dose (Up to 23 months) Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
* TSH value \> ULN and
* with baseline TSH value \<= ULN
* with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test
* with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test
* with FT3/FT4 missing within 2-week window after the abnormal TSH test.
* TSH \< LLN and
* with baseline TSH value \>= LLN
* with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test
* with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test
* with FT3/FT4 missing within 2-week window after the abnormal TSH test
Trial Locations
- Locations (79)
Local Institution - 0014
🇩🇪Frankfurt, Germany
Local Institution - 0040
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Local Institution - 0077
🇺🇸Santa Monica, California, United States
Local Institution - 0010
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0050
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0089
🇦🇹Wien, Austria
Local Institution - 0090
🇦🇹Graz, Austria
Local Institution - 0005
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0043
🇫🇷Paris, France
Local Institution - 0088
🇳🇴Bergen, Norway
Local Institution - 0035
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0057
🇪🇸Madrid, Spain
Local Institution - 0058
🇪🇸Madrid, M, Spain
Local Institution - 0073
🇫🇷Besancon Cedex, France
Local Institution - 0047
🇫🇷Avignon Cedex 9, France
Local Institution - 0075
🇬🇧Manchester, Greater Manchester, United Kingdom
Local Institution - 0032
🇬🇧Coventry, West Midlands, United Kingdom
Local Institution - 0034
🇬🇧London, United Kingdom
Local Institution - 0036
🇬🇧Lancaster, United Kingdom
Local Institution - 0069
🇬🇧Northwood, United Kingdom
Local Institution - 0033
🇬🇧Southampton, United Kingdom
Local Institution - 0060
🇪🇸Zaragoza, Spain
Scripps Clinic
🇺🇸La Jolla, California, United States
Local Institution - 0064
🇺🇸Duarte, California, United States
Local Institution - 0049
🇺🇸Clovis, California, United States
Local Institution - 0041
🇺🇸Orange, California, United States
Local Institution - 0054
🇺🇸Dallas, Texas, United States
Local Institution - 0007
🇦🇺Herston, Queensland, Australia
Local Institution - 0027
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0009
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0029
🇦🇺Malvern, Victoria, Australia
Local Institution - 0091
🇧🇪Bruxelles, Belgium
Local Institution - 0028
🇦🇺Bedford Park, Australia
Local Institution - 0024
🇨🇦Kelowna, British Columbia, Canada
Local Institution - 0070
🇨🇦Toronto, Ontario, Canada
Local Institution - 0095
🇨🇦Quebec, Canada
Local Institution - 0080
🇨🇱Santiago, Metropolitana, Chile
Local Institution - 0031
🇨🇿Brno, Czechia
Local Institution - 0045
🇫🇷Dijon, France
Local Institution - 0030
🇨🇿Olomouc, Czechia
Local Institution - 0071
🇫🇷Montpellier, France
Local Institution - 0072
🇫🇷Paris, France
Local Institution - 0046
🇫🇷Rouen Cedex, France
Local Institution - 0083
🇩🇪Cologne, Germany
Local Institution - 0082
🇩🇪Dresden, Germany
Local Institution - 0017
🇩🇪Essen, Germany
Local Institution - 0018
🇩🇪Hamburg, Germany
Local Institution - 0013
🇩🇪Heidelberg, Germany
Local Institution - 0081
🇩🇪Essen, Germany
Local Institution - 0016
🇩🇪Marburg, Germany
Local Institution - 0012
🇩🇪Hannover, Germany
Local Institution - 0020
🇮🇹Milan, Italy
Local Institution - 0015
🇩🇪Mannheim, Germany
IRCCS Istituto Nazionale Tumori Milano
🇮🇹Milano, Italy
Local Institution - 0021
🇮🇹Roma, Italy
Local Institution - 0093
🇵🇱Warszawa, Poland
Local Institution - 0087
🇳🇴Trondheim, Norway
Local Institution - 0099
🇪🇸Badajoz, Spain
Local Institution - 0059
🇪🇸Bilbao, Spain
Local Institution - 0098
🇪🇸Barcelona, Spain
Local Institution - 0061
🇪🇸Barcelona, Spain
Local Institution - 0078
🇦🇷Caba, Argentina
Local Institution - 0092
🇧🇪Leuven, Belgium
Local Institution - 0001
🇨🇱Vina del Mar, Valparaiso, Chile
Local Institution - 0079
🇨🇱Santiago, Chile
Local Institution - 0063
🇨🇦Halifax, Nova Scotia, Canada
Local Institution - 0011
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Local Institution - 0003
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0008
🇦🇺Shepparton, Victoria, Australia
Local Institution - 0002
🇨🇱Rancagua, L.g.bernardoohiggins, Chile
Local Institution - 0086
🇳🇴Oslo, Norway
Local Institution - 0067
🇵🇷San Juan, Puerto Rico
Local Institution - 0038
🇸🇬Singapore, Singapore
Local Institution - 0055
🇨🇦Trois-Rivieres, Quebec, Canada
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Local Institution - 0052
🇺🇸Seattle, Washington, United States
Local Institution - 0056
🇺🇸Aurora, Colorado, United States
Local Institution - 0062
🇺🇸New Haven, Connecticut, United States