Phase II Study of Nivolumab and Ipilimumab for Advanced Liver Cancer After Atezolizumab and Bevacizumab Treatment

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05199285

Provider View

This clinical trial is exploring whether the combination of nivolumab and ipilimumab can help shrink tumors in patients with advanced liver cancer that has not responded to previous treatment with atezolizumab and bevacizumab.

Patient Parameters

Program Overview

This study is testing a new treatment using two immunotherapy drugs, nivolumab and ipilimumab, to see if they can help shrink tumors in patients with advanced liver cancer. These drugs work by helping the immune system attack cancer cells. The trial is for patients whose cancer has spread to nearby tissues or other parts of the body, or cannot be removed by surgery, and who have not responded to previous treatment with atezolizumab and bevacizumab.

Description

The main goal of this study is to see how well nivolumab and ipilimumab can shrink tumors in patients with advanced liver cancer who have not responded to previous treatments. Researchers will also look at how long patients live after receiving the treatment, how long they remain free from cancer progression, and how well the treatment controls the disease. Additionally, the study will monitor any side effects experienced by patients.

Patients in the study will receive nivolumab through an IV for 30 minutes and ipilimumab for 90 minutes on the first day of each treatment cycle. This treatment cycle repeats every 21 days for up to 4 cycles, as long as the cancer does not progress and side effects are manageable. After these cycles, patients will continue to receive nivolumab every 28 days for up to 24 cycles, again depending on cancer progression and side effects.

After finishing the treatment, patients will have follow-up visits 30 days later and then every 3 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of liver cancer (HCC) based on specific medical criteria.
  • Have cancer that can be measured by scans.
  • Cancer must be advanced, spread to other areas, or cannot be removed by surgery.
  • Must have a specific liver function classification (Child Pugh class A).
  • Must be at a certain stage of liver cancer (BCLC stage B or C).
  • Must have previously been treated with atezolizumab and bevacizumab and shown progression that requires a change in treatment.
  • Must have a break of at least 4 weeks since the last dose of atezolizumab and bevacizumab.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have certain blood counts and liver function within specified limits.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must provide written informed consent and be willing to return for follow-up visits.
  • Must be willing to provide tissue and blood samples for research purposes.

Exclusion Criteria

  • Pregnant or nursing women, or those not willing to use contraception.
  • Recent major surgery or liver-directed therapy within specified timeframes.
  • Rapid progression on previous treatment with atezolizumab and bevacizumab.
  • Recent treatment with anti-CTLA-4 antibody for liver cancer.
  • Severe concurrent diseases or conditions that could interfere with the study.
  • Immunocompromised patients or those with active infections, except controlled hepatitis C.
  • Recent use of other investigational treatments or active cancer within the last 2 years, except certain skin or cervical cancers.
  • History of severe heart conditions or organ transplants.
  • Active autoimmune or inflammatory disorders, with some exceptions.
  • Known allergies to study drugs or components.
  • Recent use of immunosuppressive medications, with some exceptions.
  • Recent receipt of live vaccines.
  • Unresolved severe side effects from previous cancer treatments.

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