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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

Completed · Phase 1, Phase 2 · NCT01658878

Conditions: Hepatocellular Carcinoma

At a glance

Research payments reported, 2025
$385
U.S. investigators named
1
Sites paid
1
Planned or actual enrollment
657

About the trial

Sponsor
Bristol-Myers Squibb (with Ono Pharmaceutical Co., Ltd.)
Tested
Nivolumab (biological), Sorafenib (drug), Ipilimumab (drug), Cabozantinib (drug)
Dates
Started 2012-10-30; completion 2024-11-12
Results posted
Yes

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 trea…

From ClinicalTrials.gov, last updated 2025-12-24. Full record, eligibility and contacts (opens in a new tab)

Industry funding

E.r. Squibb & Sons, L.l.c. reported $385 in research payments for this study in 2025 (1 payments).

Products named: Opdivo

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Massachusetts General Physicians Organization $385

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.