NCT01658878 · CITED IN SOURCE DOCUMENTS

An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2025-12-24

The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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outcome · POSTED

Number of Participants With Serious Adverse Events (SAEs)

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outcome · POSTED

Number of Participants With Adverse Events Leading to Discontinuation

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outcome · POSTED

Number of Participants Who Died

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outcome · POSTED

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

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outcome · POSTED

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

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outcome · POSTED

Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 2

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outcome · POSTED

Objective Response Rate (ORR) by Investigator for Cohorts 3, 4, 5, and 6

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outcome · POSTED

Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 1

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outcome · POSTED

Number of Participants With Complete Response (CR) Assessed by Blinded Independent Central Review (BICR)

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outcome · POSTED

Disease Control Rate (DCR) Assessed by Blinded Independent Central Review (BICR)

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outcome · POSTED

Duration of Response (DOR) Assessed by Blinded Independent Central Review (BICR)

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outcome · POSTED

Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR)

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outcome · POSTED

Time to Progression (TTP) Assessed by Blinded Independent Central Review (BICR)

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outcome · POSTED

Time to Progression (TTP) Rate Assessed by Blinded Independent Central Review (BICR)

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outcome · POSTED

Progression Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Overall Survival (OS) Rate

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outcome · POSTED

Maximum Observed Serum Concentration (Cmax)

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outcome · POSTED

Time of Maximum Observed Serum Concentration (Tmax)

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outcome · POSTED

Area Under the Serum Concentration Time Curve in the Dosing Interval [AUC(TAU)]

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outcome · POSTED

Serum Concentration Achieved at the End of Dosing Interval (Trough Concentration) (Ctrough)

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outcome · POSTED

Serum Concentration Achieved at the End of the Infusion (Ceoinf)

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outcome · POSTED

Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax)

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outcome · POSTED

Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC)

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outcome · POSTED

Effective T-Half (T-HALF)

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outcome · POSTED

Number of Participants With Anti-drug Antibodies (ADA)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 * Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less Exclusion Criteria: * History of autoimmune disease * Any prior or current clinically significant ascites * Any history of hepatic encephalopathy
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Nivolumab intravenous solution on specific days
intervention Names
Biological: Nivolumab
label
Non-infected: Nivolumab
type
EXPERIMENTAL
description
Nivolumab intravenous solution on specific days
intervention Names
Biological: Nivolumab
label
HCV-infected: Nivolumab
type
EXPERIMENTAL
description
Nivolumab intravenous solution on specific days
intervention Names
Biological: Nivolumab
label
HBV-infected: Nivolumab
type
EXPERIMENTAL
description
Nivolumab intravenous solution on specific days
intervention Names
Biological: Nivolumab
label
Nivolumab
type
EXPERIMENTAL
description
Sorafenib tablets on specific days
intervention Names
Drug: Sorafenib
label
Sorafenib
type
ACTIVE_COMPARATOR
description
Nivolumab intravenous solution + Ipilimumab intravenous solution on specific days
intervention Names
Biological: Nivolumab
Drug: Ipilimumab
label
Nivolumab plus Ipilimumab Combination
type
EXPERIMENTAL
description
Nivolumab intravenous solution on specific days
intervention Names
Biological: Nivolumab
label
Child-Pugh B
type
EXPERIMENTAL
description
Nivolumab intravenous solution + cabozantinib oral tablets on specific days
intervention Names
Drug: Cabozantinib
label
Nivolumab plus Cabozantinib Combination
type
EXPERIMENTAL
description
Nivolumab intravenous solution + Ipilimumab intravenous solution + cabozantinib oral tablets on specific days
intervention Names
Drug: Cabozantinib
label
Nivolumab plus Ipilimumab plus Cabozantinib
type
EXPERIMENTAL

interventions

arm Group Labels
Child-Pugh B
HBV-infected: Nivolumab
HCV-infected: Nivolumab
Nivolumab
Nivolumab plus Ipilimumab Combination
Non-infected: Nivolumab
name
Nivolumab
other Names
BMS-936558
type
BIOLOGICAL
arm Group Labels
Sorafenib
name
Sorafenib
type
DRUG
arm Group Labels
Nivolumab plus Ipilimumab Combination
name
Ipilimumab
type
DRUG
arm Group Labels
Nivolumab plus Cabozantinib Combination
Nivolumab plus Ipilimumab plus Cabozantinib
name
Cabozantinib
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 657
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
measure
Number of Participants With Adverse Events (AEs)
time Frame
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
description
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
measure
Number of Participants With Serious Adverse Events (SAEs)
time Frame
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
description
An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
measure
Number of Participants With Adverse Events Leading to Discontinuation
time Frame
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
description
Number of participants who died during the study.
measure
Number of Participants Who Died
time Frame
From first dose of study medication until study closure (Up to approximately 144 months)
description
Participants with abnormalities in liver function tests related to potential drug-induced liver injury. Blood samples were collected and analyzed for liver function parameters, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Abnormalities were assessed relative to the upper limit of normal (ULN) for each parameter. Abbreviations: ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal.
measure
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
time Frame
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
description
Number of participants with thyroid-related laboratory abnormalities during the study. Blood samples were collected and analyzed for thyroid function markers (FT3, FT4). Abnormalities were assessed against LLN and ULN for each parameter. Abbreviations: FT3 = Free T3; FT4 = Free T4; LLN = Lower Limit of Normal; ULN = Upper Limit of Normal; TSH = Thyroid Stimulating Hormone
measure
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
time Frame
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
description
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 2
time Frame
From the start of the study treatment until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
description
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Objective Response Rate (ORR) by Investigator for Cohorts 3, 4, 5, and 6
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 5) until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)

secondary Outcomes

description
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 1
time Frame
From the start of the study treatment until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
description
The number of participants whose best overall response (BOR) is CR in the population of interest. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
measure
Number of Participants With Complete Response (CR) Assessed by Blinded Independent Central Review (BICR)
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to approximately 144 months after first dose
description
The percentage of participants whose best overall response (BOR) is CR, PR or SD in the population of interest. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Failure to meet criteria for complete or partial response, in the absence of progressive disease. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Disease Control Rate (DCR) Assessed by Blinded Independent Central Review (BICR)
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
description
DOR is defined as the time from the first documented objective response (either complete or partial response) until the date of disease progression or death from any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Duration of Response (DOR) Assessed by Blinded Independent Central Review (BICR)
time Frame
From first documented response to first documented progression or death, whichever occurs first (Up to approximately 144 months)
description
Time to Response (TTR) defined as the time from randomization to the date of the first confirmed CR or PR for Cohort 3, 4 and 6, and from the first dosing date of study medication to the date of the first confirmed CR or PR for cohort 1, 2 and 5. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure
Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR)
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of attainment of complete response (CR) or partial response (PR) (up to approximately 144 months)
description
Time to Progression (TTP) is defined from the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of the first objectively documented disease progression. Participants who have not progressed as assessed by radiography will be censored at the last tumor assessment date prior to subsequent anti-cancer therapy. Participants who have no on-study tumor assessments were censored at the date of randomization. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Time to Progression (TTP) Assessed by Blinded Independent Central Review (BICR)
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
description
TTP rate is defined as the percentage of participants without disease progression at select time points (milestones) during the study. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Time to Progression (TTP) Rate Assessed by Blinded Independent Central Review (BICR)
time Frame
At 6 and 12 months
description
PFS is defined as the time from randomization date or first dosing date of study medication to the date of the first objectively documented tumor progression or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
measure
Progression Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to documented disease progression or death, whichever occurs first (up to approximately 144 months)
description
OS is defined as the time from randomization date or first dosing date of study medication to the date of death (due to any cause). Participants who were alive were censored at the last known alive dates.
measure
Overall Survival (OS)
time Frame
From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to the date of death or date last known alive (up to approximately 144 months)
description
OS rate is defined as the percentage of participants who are still alive at certain time points during the study.
measure
Overall Survival (OS) Rate
time Frame
At 6, 12, 24, 48 and 60 months
description
Cmax is the maximum observed serum concentration.
measure
Maximum Observed Serum Concentration (Cmax)
time Frame
At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)
description
Tmax is the time taken to reach the maximum observed serum concentration (Cmax).
measure
Time of Maximum Observed Serum Concentration (Tmax)
time Frame
At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)

Full study description

brief Summary: The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.
detailed Description: Study Classification: Pharmacokinetics/Pharmacodynamics

Source references

references

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