Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Pembrolizumab

Liver Extracts

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

Cabozantinib S-malate

Gentry George King

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.

OUTLINE:

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.

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

A Phase 2 Trial of Cabozantinib and Pembrolizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma

Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (by blinded central review). Assessment of objective response per Response Evaluation Criteria in Solid Tumors version 1.1 of target lesions by cross sectional imaging (either CT or MRI), defined as the following: 1.) Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response Rate is defined as percentage of CR + PR.

Will be assessed per RECIST v1.1 and iRECIST. Assessment of objective response per Response Evaluation Criteria in Solid Tumors version 1.1 of target lesions by cross sectional imaging (either CT or MRI), defined as the following: 1.) Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response Rate is defined as percentage of CR + PR.

Defined as time from study registration to radiographic progression per RECIST v1.1 (blinded central assessment), clinical progression, or death of any cause.

Defined as time from study registration to death of any cause.

Will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.

Exelixis

University of Washington

Assistant Professor

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.

Cabozantinib S-malate: Given PO

Pembrolizumab: Given IV

Treatment (Cabozantinib S-malate, Pembrolizumab)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Madeline Jacoby

Number of Participants With Objective Response (Complete or Partial Response)

Number of Participants With Disease Control (Complete + Partial Response + Stable Disease)

Spots Global Cancer Trial Database for Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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