Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer
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|ClinicalTrials.gov Identifier: NCT04442581|
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Hepatocellular Carcinoma BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma||Drug: Cabozantinib S-malate Biological: Pembrolizumab||Phase 2|
Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21 and pembrolizumab intravenously (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. Disease assessment by imaging will be performed every 9 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial of Cabozantinib and Pembrolizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma|
|Estimated Study Start Date :||March 22, 2021|
|Estimated Primary Completion Date :||September 13, 2023|
|Estimated Study Completion Date :||September 13, 2024|
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.
Drug: Cabozantinib S-malate
- Objective response (complete or partial response) [ Time Frame: Up to 2 years from study start date ]Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (by blinded central review).
- Objective response (complete or partial response) [ Time Frame: Up to 2 years from study start date ]Will be assessed per immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) (blinded central review).
- Disease control (complete + partial response + stable disease) [ Time Frame: Up to 2 years from study start date ]Will be assessed per RECIST v1.1 and iRECIST.
- Progression-free survival [ Time Frame: Up to 3 years from study start date ]Defined as time from study registration to radiographic progression per RECIST v1.1 (blinded central assessment), clinical progression, or death of any cause.
- Overall survival [ Time Frame: Up to 3 years from study start date ]Defined as time from study registration to death of any cause.
- Incidence of adverse events [ Time Frame: Up to 30 days after the last dose of cabozantinib or pembrolizumab ]Will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442581
|Contact: Susan Feldmanemail@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Susan Feldman 206-606-6457 firstname.lastname@example.org|
|Principal Investigator: Kaylyn Kit Man Wong|
|Principal Investigator:||Kaylyn Kit Man Wong||Fred Hutch/University of Washington Cancer Consortium|