Maintenance Zanzalintinib and Durvalumab in Participants With Advanced Hepatocellular Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Amit Mahipal
Study ID
NCT07226063
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Participants will receive 1500 mg durvalumab through intravenous (IV) administration over a period of 60 minutes on Day 1 of each 28-day cycle.
  • Zanzalintinib — DRUG
    Participants will receive 60 mg durvalumab orally on Days 1-28 of each 28-day cycle.

Study Details

This research study is for people who were treated with tremelimumab and durvalumab for advanced liver cancer and who are currently receiving durvalumab. Participants in this study will receive a drug called zanzalintinib. They will also continue receiving durvalumab. Studies have shown that patients with advanced liver cancer who had tremelimumab and durvalumab may benefit from taking zanzalintinib while they are taking durvalumab. Zanzalintinib is an investigational drug. This means it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced liver cancer. Durvalumab is approved by the FDA for patients with advanced liver cancer. The purpose of this study is to find out if taking zanzalintinib with durvalumab will improve how long people with advanced liver cancer will live.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + zanzalintinib
    Participants will receive treatment regimen of durvalumab and zanzalintinib. Each treatment cycle is 28 days. Participants will continue to receive treatment until disease progression, death, or other reasons for withdrawal.

Primary Outcome Measure

Progression-Free Survival (PFS) at 16 weeks [ Time Frame: Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Amit Mahipal, MD, MBBS
Amit Mahipal, MD, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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