A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT05199285
Phase
PHASE2
Status
Terminated

Conditions

  • BCLC Stage B Hepatocellular Carcinoma
  • BCLC Stage C Hepatocellular Carcinoma
  • Locally Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8
  • Unresectable Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

Study Details

This phase II trial tests whether nivolumab and ipilimumab works to shrink tumors in patients with liver cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab and ipilimumab may be effective in killing tumor cells in patients with liver cancer.

Key Dates

Start date
Jan 19, 2023
Status verified
Sep 2025
Primary completion
Sep 4, 2025
Completion
Sep 4, 2025

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, ipilimumab)
    Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Confirmed objective response rate (ORR) [ Time Frame: Up to 6 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama- BirminghamBirminghamAlabama35233-
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136-
Mayo Clinic in RochesterRochesterMinnesota55905-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Birmingham, AL

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Alabama- Birmingham· Birmingham, ALUniversity of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLMayo Clinic in Rochester· Rochester, MNRutgers Cancer Institute of New Jersey· New Brunswick, NJVanderbilt University/Ingram Cancer Center· Nashville, TN

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