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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01658878
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 30, 2012
Status verified
Dec 2025
Primary completion
Nov 12, 2024
Completion
Nov 12, 2024

Study Design

Enrollment
657 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome 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) ]

Locations (10)

FacilityCityStateZIP
Local Institution - 0008Los AngelesCalifornia90033
Local Institution - 0048Washington D.C.District of Columbia20007
Local Institution - 0053PensacolaFlorida32504
Local Institution - 0047AtlantaGeorgia30322
Local Institution - 0025BostonMassachusetts02114
Local Institution - 0002Ann ArborMichigan48109-5331
Local Institution - 0054HackensackNew Jersey07601
Local Institution - 0067PatersonNew Jersey07503
Local Institution - 0001PortlandOregon97213
The University Of Texas MD Anderson Cancer CenterHoustonTexas77030

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Local Institution - 0008· Los Angeles, CALocal Institution - 0048· Washington D.C., DCLocal Institution - 0053· Pensacola, FLLocal Institution - 0047· Atlanta, GALocal Institution - 0025· Boston, MALocal Institution - 0002· Ann Arbor, MI

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