Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04442581
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Hepatocellular Carcinoma
  • BCLC Stage B Hepatocellular Carcinoma
  • BCLC Stage C Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies how well cabozantinib and pembrolizumab work for the first-line treatment of patients with liver cancer who are not eligible for local therapy (i.e. advanced stage). Cabozantinib may stop the growth of tumor cells by blocking some cell surface receptors and signaling pathways inside the tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer. Giving cabozantinib and pembrolizumab together may work better in treating patients with advanced liver cancer compared to cabozantinib or pembrolizumab alone.

Key Dates

Start date
Apr 20, 2021
Status verified
Mar 2023
Primary completion
Dec 13, 2021
Completion
Mar 8, 2022

Study Design

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

Arms

  • Experimental: Treatment (cabozantinib S-malate, pembrolizumab)
    Patients receive cabozantinib S-malate PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Objective Response (Complete or Partial Response) [ Time Frame: Assessed at baseline, every 2 cycles until cycle 4, then every 3 cycles until disease progression, up to 10 months 16 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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