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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 (CheckMate040)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib
Biological: Nivolumab
Drug: Ipilimumab
Drug: Cabozantinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01658878
2012-001514-42 (EudraCT Number)
CA209-040

Details and patient eligibility

About

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.

Full description

Study Classification: Pharmacokinetics/Pharmacodynamics

Enrollment

659 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

659 participants in 9 patient groups

Non-infected: Nivolumab
Experimental group
Description:
Nivolumab intravenous solution on specific days
Treatment:
Biological: Nivolumab
HCV-infected: Nivolumab
Experimental group
Description:
Nivolumab intravenous solution on specific days
Treatment:
Biological: Nivolumab
HBV-infected: Nivolumab
Experimental group
Description:
Nivolumab intravenous solution on specific days
Treatment:
Biological: Nivolumab
Nivolumab
Experimental group
Description:
Nivolumab intravenous solution on specific days
Treatment:
Biological: Nivolumab
Sorafenib
Active Comparator group
Description:
Sorafenib tablets on specific days
Treatment:
Drug: Sorafenib
Nivolumab plus Ipilimumab Combination
Experimental group
Description:
Nivolumab intravenous solution + Ipilimumab intravenous solution on specific days
Treatment:
Drug: Ipilimumab
Biological: Nivolumab
Child-Pugh B
Experimental group
Description:
Nivolumab intravenous solution on specific days
Treatment:
Biological: Nivolumab
Nivolumab plus Cabozantinib Combination
Experimental group
Description:
Nivolumab intravenous solution + cabozantinib oral tablets on specific days
Treatment:
Drug: Cabozantinib
Nivolumab plus Ipilimumab plus Cabozantinib
Experimental group
Description:
Nivolumab intravenous solution + Ipilimumab intravenous solution + cabozantinib oral tablets on specific days
Treatment:
Drug: Cabozantinib

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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