A Phase II Study to Evaluate the Effects of Sequential Therapy With the Anti c-MET/VEGFR Tyrosine Kinase Inhibitor (TKI), Cabozantinib, Followed by an Anti-PD-1 Antibody (Nivolumab) in Patients With Advanced HCC Who Progressed on First-line Therapy
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT05039736
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cabozantinib — DRUGGiven by PO
- Nivolumab — DRUGGiven by IV
Study Details
The purpose of this clinical research study is to learn about the safety and effectiveness of cabozantinib and nivolumab in people with hepatocellular carcinoma (HCC).
Key Dates
- Start date
- Feb 24, 2023
- Status verified
- May 2023
- Primary completion
- May 3, 2023
- Completion
- May 3, 2023
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: cabozantinibcabozantinib by mouth every day for 6 weeks
- Experimental: nivolumabnivolumab by vein every 4 weeks for up to 2 years
Primary Outcome Measure
To evaluate overall response rate [ Time Frame: through study completion, an average of 1 year ]
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