A Phase 2 interventional study of Nivolumab and Relatlimab in Hepatocellular Carcinoma, Hepatoma and Liver Cancer, Adult, sponsored by Bristol-Myers Squibb. Completed at 65 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 266 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Biological: Nivolumab
Biological: Nivolumab · Biological: Relatlimab
Biological: Nivolumab · Biological: Relatlimab
Specified dose on specified days
Also known as: OPDIVO, BMS-936558
Specified dose on specified days
Also known as: BMS-986016
Objective Response Rate(ORR) Assessed by BICR
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Disease Control Rate Assessed by BICR
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Duration of Response Assessed by BICR
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Progression Free Survival(PFS) Assessed by BICR
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Objective Response Rate Assessed by Investigator
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Disease Control Rate Assessed by Investigator
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Duration of Response Assessed by Investigator
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Progression Free Survival(PFS) Assessed by Investigator
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to the date of death from any cause. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Number of Participants With Adverse Events
Number of participants with an Adverse Event. An Adverse Event 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.
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Number of Participants With Serious Adverse Events
Number of participants with Serious Adverse Events A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Number of Participants With Adverse Events Leading to Discontinuation
Number of participants with Adverse Events Leading to Discontinuation
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Death Summary
Number of participants who died.
Time frame: From randomization to primary completion date (Approximately 29.5 Months)
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Number of participants with clinical laboratory abnormalities in specific liver tests
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests
Number of participants with clinical laboratory abnormalities in thyroid tests
Time frame: From randomization to primary completion date (Approximately 29.5 Months). Includes events reported between first dose and 30 days after last dose of study therapy.
| Milestone | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Started | 128 | 114 | 24 |
| Completed | 127 | 113 | 24 |
| Not completed | 1 | 1 | 0 |
| Withdrew: Participant withdrew consent | 1 | 0 | 0 |
| Withdrew: Adverse event unrelated to study drug | 0 | 1 | 0 |
| Milestone | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Started | 127 | 113 | 24 |
| Completed | 3 | 1 | 0 |
| Not completed | 124 | 112 | 24 |
| Withdrew: Participant withdrew consent | 2 | 5 | 1 |
| Withdrew: Death | 1 | 2 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
| Withdrew: Participant no longer meets study criteria | 0 | 1 | 0 |
| Withdrew: Disease progression | 85 | 63 | 16 |
| Withdrew: Study drug toxicity | 3 | 10 | 4 |
| Withdrew: Adverse event unrelated to study drug | 11 | 6 | 1 |
| Withdrew: Other reasons | 1 | 2 | 0 |
| Withdrew: Still on-going treatment | 21 | 22 | 2 |
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
| Percentage | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Objective Response Rate(ORR) Assessed by BICR | 13.3 (7.9 to 20.4) | 10.5 (5.6 to 17.7) | 12.5 (2.7 to 32.4) |
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
| Percentage | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Disease Control Rate Assessed by BICR | 44.5 (35.7 to 53.6) | 44.7 (35.4 to 54.3) | 33.3 (15.6 to 55.3) |
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
| Months | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Duration of Response Assessed by BICR | 5.82 (5.55 to NA) | NA (5.32 to NA) | NA (7.39 to NA) |
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
| Months | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Progression Free Survival(PFS) Assessed by BICR | 2.00 (1.91 to 3.75) | 2.00 (1.87 to 3.71) | 1.94 (1.74 to 3.71) |
Objective Response Rate (ORR) (as per Recists v1.1) is defined as the percentage of participants whose best overall response (BOR) is either confirmed complete response (CR) or confirmed partial response (PR) based on investigator assessments among all participants in the respective analysis set. BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of first objectively documented progression or death due to any cause or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. Confirmation of response is required at least 4 weeks after the initial response.
| Percentage | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Objective Response Rate Assessed by Investigator | 14.1 (8.6 to 21.3) | 13.2 (7.6 to 20.8) | 20.8 (7.1 to 42.2) |
Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants.
| Percentage | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Disease Control Rate Assessed by Investigator | 48.4 (39.5 to 57.4) | 50.9 (41.3 to 60.4) | 41.7 (22.1 to 63.4) |
Duration of Response (DOR) (as per Recists v1.1) is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have an event on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only.
| Months | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Duration of Response Assessed by Investigator | 10.94 (4.63 to NA) | NA (5.55 to NA) | 12.42 (3.61 to NA) |
PFS (as per Recists v1.1) is defined as the time between the date of randomization and the date of first documented tumor progression or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death.
| Months | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Progression Free Survival(PFS) Assessed by Investigator | 3.32 (2.00 to 4.01) | 3.65 (1.97 to 4.30) | 1.94 (1.68 to 3.75) |
Overall survival (OS) is defined as the time from randomization to the date of death from any cause. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up.
| Months | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Overall Survival (OS) | 12.68 (9.40 to 18.76) | 12.19 (9.49 to 14.52) | 8.21 (4.76 to 16.92) |
Number of participants with an Adverse Event. An Adverse Event 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.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Participants With Adverse Events | 119 | 108 | 22 |
Number of participants with Serious Adverse Events A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Participants With Serious Adverse Events | 43 | 46 | 14 |
Number of participants with Adverse Events Leading to Discontinuation
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Participants With Adverse Events Leading to Discontinuation | 13 | 14 | 5 |
Number of participants who died.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Death Summary | 67 | 60 | 18 |
Number of participants with clinical laboratory abnormalities in specific liver tests
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| ALT OR AST> 5XULN | 25 | 41 | 6 |
| ALT OR AST> 10XULN | 7 | 16 | 2 |
| TOTAL BILIRUBIN > 2XULN | 17 | 14 | 2 |
| CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN >2XULN WITHIN 30 DAYS | 14 | 10 | 1 |
Number of participants with clinical laboratory abnormalities in thyroid tests
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| TSH > ULN | 38 | 42 | 2 |
| TSH > ULN WITH TSH ≤ ULN AT BASELINE | 14 | 18 | 1 |
| TSH <LLN WITH TSH ≥ LLN AT BASELINE | 16 | 26 | 2 |
Collected over Adverse Events and Serious Adverse Events: (From first dose to last dose to primary completion date) : Approximately 29.5 months All-Cause mortality (From randomization to primary completion date): Approximately 29.5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A | 68/128 (53.1%) | 65/127 (51.2%) | 104/127 (81.9%) |
| Treatment B | 60/114 (52.6%) | 65/113 (57.5%) | 102/113 (90.3%) |
| Treatment C | 18/24 (75%) | 20/24 (83.3%) | 22/24 (91.7%) |
| Event | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 29/127 | 24/113 | 6/24 |
| MyocarditisCardiac disorders | 0/127 | 1/113 | 2/24 |
| AscitesGastrointestinal disorders | 3/127 | 3/113 | 1/24 |
| Colitis microscopicGastrointestinal disorders | 0/127 | 0/113 | 1/24 |
| Oesophageal varices haemorrhageGastrointestinal disorders | 1/127 | 0/113 | 1/24 |
| PancreatitisGastrointestinal disorders | 0/127 | 0/113 | 1/24 |
| Multiple organ dysfunction syndromeGeneral disorders | 0/127 | 0/113 | 1/24 |
| PyrexiaGeneral disorders | 2/127 | 1/113 | 1/24 |
| HypersensitivityImmune system disorders | 0/127 | 0/113 | 1/24 |
| COVID-19 pneumoniaInfections and infestations | 0/127 | 0/113 | 1/24 |
| Event | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Aspartate aminotransferase increasedInvestigations | 33/127 | 33/113 | 3/24 |
| AstheniaGeneral disorders | 16/127 | 9/113 | 7/24 |
| AnaemiaBlood and lymphatic system disorders | 21/127 | 16/113 | 6/24 |
| DiarrhoeaGastrointestinal disorders | 11/127 | 20/113 | 6/24 |
| Alanine aminotransferase increasedInvestigations | 21/127 | 27/113 | 3/24 |
| PruritusSkin and subcutaneous tissue disorders | 24/127 | 16/113 | 4/24 |
| Oedema peripheralGeneral disorders | 17/127 | 20/113 | 2/24 |
| AscitesGastrointestinal disorders | 6/127 | 11/113 | 4/24 |
| Decreased appetiteMetabolism and nutrition disorders | 10/127 | 15/113 | 4/24 |
| RashSkin and subcutaneous tissue disorders | 8/127 | 12/113 | 4/24 |
All Randomized Participants
| Age, Continuous(Years) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Mean | 64.0 ± 10.4 | 63.3 ± 11.2 | 68.1 ± 10.9 | 64.1 ± 10.8 |
| Sex: Female, Male(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Female | 23 | 21 | 2 | 46 |
| Male | 105 | 93 | 22 | 220 |
| Ethnicity (NIH/OMB)(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Hispanic or Latino | 14 | 16 | 0 | 30 |
| Not Hispanic or Latino | 65 | 47 | 15 | 127 |
| Unknown or Not Reported | 49 | 51 | 9 | 109 |
| Race/Ethnicity, Customized(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| White | 61 | 54 | 12 | 127 |
| Black or African American | 2 | 1 | 0 | 3 |
| Asian | 28 | 19 | 2 | 49 |
| American Indian or Alaska Native | 5 | 6 | 0 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Other | 3 | 5 | 0 | 8 |
| Chinese | 16 | 16 | 4 | 36 |
| Japanese | 7 | 4 | 3 | 14 |
| Malay | 0 | 1 | 0 | 1 |
| Asian Other | 6 | 8 | 2 | 16 |
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