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An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03662659
Enrollment
274
Registered
2018-09-07
Start date
2018-10-16
Completion date
2024-01-18
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Cancer of the Stomach, Esophagogastric Junction

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.

Interventions

BIOLOGICALBMS-986213

Relatlimab + Nivolumab specified dose on specified days

BIOLOGICALNivolumab

Specified dose on specified days

DRUGXELOX

Oxaliplatin + capecitabine

DRUGFOLFOX

Oxaliplatin + leucovorin + fluorouracil

DRUGSOX

Oxaliplatin + tegafur/gimeracil/oteracil potassium

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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/

Design outcomes

Primary

MeasureTime frameDescription
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) ParticipantsUp to 25 monthsThe 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
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended CollectionFrom randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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 Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

Secondary

MeasureTime frameDescription
Overall Survival (OS)From the date of randomization to the date of death due to any cause (Up to 63 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)From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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. Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From first dose to 30 days post last dose (Up to 60 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). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization, results in significant disability, is a birth defect, or is an important medical event.
Objective Response Rate (ORR)From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
Number of Participants With Laboratory Abnormalities in Specific Liver TestsFrom first dose to 30 days post last dose (Up to 60 months)Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. 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 ULN
Number of Participants With Laboratory Abnormalities in Specific Thyroid TestsFrom first dose to 30 days post last dose (Up to 60 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
Number of Participants Who DiedUp to 60 monthsNumber of participants who died in each arm.
Duration of Response (DOR)From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 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 complete response (CR) or partial response (PR) 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. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions

Countries

Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Italy, Norway, Poland, Puerto Rico, Singapore, Spain, United Kingdom, United States

Participant flow

Pre-assignment details

274 participants randomized and 271 treated.

Participants by arm

ArmCount
BMS986213 + Chemotherapy
BMS986213 Q3W + Investigator Choice (IC) Chemotherapy
138
Nivolumab + Chemotherapy
Nivolumab Q3W + Investigator Choice (IC) Chemotherapy
136
Total274

Withdrawals & dropouts

PeriodReasonFG000FG001
Pre-treatmentOther reasons10
Pre-treatmentParticipant no longer met study criteria11
TreatmentAdministrative reasons by sponsor10
TreatmentAdverse Event unrelated to Study Drug76
TreatmentCompleted Treatment02
TreatmentDeath119
TreatmentDisease Progression8597
Treatmentmaximum clinical benefit02
TreatmentOther reasons108
TreatmentParticipant no longer meets study criteria10
TreatmentPoor/Non-compliance10
TreatmentStudy Drug Toxicity199
TreatmentWithdrawal by Subject11

Baseline characteristics

CharacteristicBMS986213 + ChemotherapyNivolumab + ChemotherapyTotal
Age, Continuous59.4 Years
STANDARD_DEVIATION 12.1
61.8 Years
STANDARD_DEVIATION 11.3
60.6 Years
STANDARD_DEVIATION 11.7
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants10 Participants27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
73 Participants80 Participants153 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
48 Participants46 Participants94 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Asian
5 Participants3 Participants8 Participants
Race/Ethnicity, Customized
Asian Indian
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Chinese
0 Participants5 Participants5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Other
2 Participants4 Participants6 Participants
Race/Ethnicity, Customized
White
128 Participants122 Participants250 Participants
Sex: Female, Male
Female
44 Participants38 Participants82 Participants
Sex: Female, Male
Male
94 Participants98 Participants192 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
122 / 138118 / 136
other
Total, other adverse events
130 / 136133 / 135
serious
Total, serious adverse events
110 / 136100 / 135

Outcome results

Primary

BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants

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

Time frame: Up to 25 months

Population: All randomized LAG-3 positive (\>=1%) participants

ArmMeasureValue (NUMBER)
BMS986213 + ChemotherapyBICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants48.5 Percentage of Participants
Nivolumab + ChemotherapyBICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants61.2 Percentage of Participants
Primary

BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection

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 Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

Population: All randomized LAG-3 positive (\>=1%) participants

ArmMeasureValue (NUMBER)
BMS986213 + ChemotherapyBICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection27.8 Percentage of Participants
Nivolumab + ChemotherapyBICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection43.9 Percentage of Participants
Secondary

Duration of Response (DOR)

Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented complete response (CR) or partial response (PR) 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. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions

Time frame: From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

Population: All randomized responders with LAG-3 positive (\>=1%), and all randomized responders with LAG-3 negative (\<1%), and all randomized responders

ArmMeasureGroupValue (MEDIAN)
BMS986213 + ChemotherapyDuration of Response (DOR)BICR-assessed with LAG-3 expression >=1%7.72 Months
BMS986213 + ChemotherapyDuration of Response (DOR)BICR-assessed with LAG-3 expression <1%5.44 Months
BMS986213 + ChemotherapyDuration of Response (DOR)BICR-assessed Overall5.68 Months
BMS986213 + ChemotherapyDuration of Response (DOR)Investigator-assessed with LAG-3 expression >=1%6.21 Months
BMS986213 + ChemotherapyDuration of Response (DOR)Investigator-assessed with LAG-3 expression <1%5.54 Months
BMS986213 + ChemotherapyDuration of Response (DOR)Investigator-assessed Overall5.88 Months
Nivolumab + ChemotherapyDuration of Response (DOR)Investigator-assessed with LAG-3 expression <1%8.31 Months
Nivolumab + ChemotherapyDuration of Response (DOR)BICR-assessed with LAG-3 expression >=1%10.78 Months
Nivolumab + ChemotherapyDuration of Response (DOR)Investigator-assessed with LAG-3 expression >=1%10.28 Months
Nivolumab + ChemotherapyDuration of Response (DOR)BICR-assessed with LAG-3 expression <1%5.55 Months
Nivolumab + ChemotherapyDuration of Response (DOR)Investigator-assessed Overall9.92 Months
Nivolumab + ChemotherapyDuration of Response (DOR)BICR-assessed Overall6.93 Months
Secondary

Number of Participants Who Died

Number of participants who died in each arm.

Time frame: Up to 60 months

Population: All treated participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BMS986213 + ChemotherapyNumber of Participants Who Died122 Participants
Nivolumab + ChemotherapyNumber of Participants Who Died118 Participants
Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization, results in significant disability, is a birth defect, or is an important medical event.

Time frame: From first dose to 30 days post last dose (Up to 60 months)

Population: All treated participants

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BMS986213 + ChemotherapyNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Adverse Events (AEs)135 Participants
BMS986213 + ChemotherapyNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Serious Adverse Events (SAEs)99 Participants
BMS986213 + ChemotherapyNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Adverse Events leading to discontinuation76 Participants
Nivolumab + ChemotherapyNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Adverse Events (AEs)135 Participants
Nivolumab + ChemotherapyNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Serious Adverse Events (SAEs)87 Participants
Nivolumab + ChemotherapyNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Adverse Events leading to discontinuation56 Participants
Secondary

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. 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 ULN

Time frame: From first dose to 30 days post last dose (Up to 60 months)

Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 3xULN31 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 5xULN12 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 10xULN4 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 20xULN2 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsTOTAL BILIRUBIN > 2xULN6 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALP > 1.5xULN50 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 1.5xULN WITHIN ONE DAY5 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 1.5xULN WITHIN 30 DAYS5 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 2xULN WITHIN ONE DAY4 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 2xULN WITHIN 30 DAYS4 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 1.5xULN WITHIN 30 DAYS2 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 3xULN14 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALP > 1.5xULN56 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 5xULN5 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 2xULN WITHIN 30 DAYS2 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 10xULN1 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 1.5xULN WITHIN ONE DAY2 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsALT or AST > 20xULN0 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsCONCURRENT ALT OR AST ELEVATION > 3xULN WITH TOTAL BILIRUBIN > 2xULN WITHIN ONE DAY2 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Liver TestsTOTAL BILIRUBIN > 2xULN3 Participants
Secondary

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

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

Time frame: From first dose to 30 days post last dose (Up to 60 months)

Population: All treated participants with thyroid stimulating hormone (TSH) abnormality measurement

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN39 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH TSH <= ULN AT BASELINE35 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN24 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN15 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH FT3/FT4 TEST MISSING18 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN42 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH TSH >= LLN AT BASELINE40 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN22 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN12 Participants
BMS986213 + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH FT3/FT4 TEST MISSING19 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN11 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN43 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN26 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH TSH <= ULN AT BASELINE33 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH FT3/FT4 TEST MISSING11 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN20 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH TSH >= LLN AT BASELINE22 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN19 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN10 Participants
Nivolumab + ChemotherapyNumber of Participants With Laboratory Abnormalities in Specific Thyroid TestsTSH > ULN WITH FT3/FT4 TEST MISSING24 Participants
Secondary

Objective Response Rate (ORR)

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. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

Population: All randomized LAG-3 positive (\>=1%) participants, and all randomized LAG-3 negative (\<1%) participants, and all randomized participants

ArmMeasureGroupValue (NUMBER)
BMS986213 + ChemotherapyObjective Response Rate (ORR)BICR-assessed Overall27.5 Percentage of participants
BMS986213 + ChemotherapyObjective Response Rate (ORR)Investigator-assessed with LAG-3 expression <1%36.6 Percentage of participants
BMS986213 + ChemotherapyObjective Response Rate (ORR)Investigator-assessed with LAG-3 expression >=1%53.6 Percentage of participants
BMS986213 + ChemotherapyObjective Response Rate (ORR)Investigator-assessed Overall48.6 Percentage of participants
BMS986213 + ChemotherapyObjective Response Rate (ORR)BICR-assessed with LAG-3 expression <1%26.8 Percentage of participants
Nivolumab + ChemotherapyObjective Response Rate (ORR)Investigator-assessed Overall50.7 Percentage of participants
Nivolumab + ChemotherapyObjective Response Rate (ORR)BICR-assessed with LAG-3 expression <1%36.8 Percentage of participants
Nivolumab + ChemotherapyObjective Response Rate (ORR)BICR-assessed Overall41.9 Percentage of participants
Nivolumab + ChemotherapyObjective Response Rate (ORR)Investigator-assessed with LAG-3 expression >=1%54.1 Percentage of participants
Nivolumab + ChemotherapyObjective Response Rate (ORR)Investigator-assessed with LAG-3 expression <1%42.1 Percentage of participants
Secondary

Overall Survival (OS)

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.

Time frame: From the date of randomization to the date of death due to any cause (Up to 63 months)

Population: All randomized LAG-3 positive (\>=1%) participants, and all randomized LAG-3 negative (\<1%) participants, and all randomized participants

ArmMeasureGroupValue (MEDIAN)
BMS986213 + ChemotherapyOverall Survival (OS)LAG-3 Expression >=1%14.19 Months
BMS986213 + ChemotherapyOverall Survival (OS)LAG-3 Expression <1%9.72 Months
BMS986213 + ChemotherapyOverall Survival (OS)Overall12.65 Months
Nivolumab + ChemotherapyOverall Survival (OS)LAG-3 Expression >=1%14.98 Months
Nivolumab + ChemotherapyOverall Survival (OS)LAG-3 Expression <1%15.51 Months
Nivolumab + ChemotherapyOverall Survival (OS)Overall15.15 Months
Secondary

Progression-Free Survival (PFS)

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. Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

Time frame: From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

Population: All randomized LAG-3 positive (\>=1%) participants, and all randomized LAG-3 negative (\<1%) participants, and all randomized participants

ArmMeasureGroupValue (MEDIAN)
BMS986213 + ChemotherapyProgression-Free Survival (PFS)BICR-assessed Overall7.13 Months
BMS986213 + ChemotherapyProgression-Free Survival (PFS)BICR-assessed LAG-3 Expression >=1%7.26 Months
BMS986213 + ChemotherapyProgression-Free Survival (PFS)BICR-assessed LAG-3 Expression <1%6.80 Months
BMS986213 + ChemotherapyProgression-Free Survival (PFS)Investigator-assessed LAG-3 Expression >=1%6.97 Months
BMS986213 + ChemotherapyProgression-Free Survival (PFS)Investigator-assessed LAG-3 Expression <1%5.39 Months
BMS986213 + ChemotherapyProgression-Free Survival (PFS)Investigator-assessed Overall6.64 Months
Nivolumab + ChemotherapyProgression-Free Survival (PFS)Investigator-assessed LAG-3 Expression <1%9.69 Months
Nivolumab + ChemotherapyProgression-Free Survival (PFS)Investigator-assessed LAG-3 Expression >=1%8.31 Months
Nivolumab + ChemotherapyProgression-Free Survival (PFS)BICR-assessed LAG-3 Expression >=1%10.84 Months
Nivolumab + ChemotherapyProgression-Free Survival (PFS)Investigator-assessed Overall8.31 Months
Nivolumab + ChemotherapyProgression-Free Survival (PFS)BICR-assessed LAG-3 Expression <1%10.45 Months
Nivolumab + ChemotherapyProgression-Free Survival (PFS)BICR-assessed Overall10.45 Months

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026