TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer

Advanced Adult Primary Liver Cancer Clinical Trial

Official title: Phase II Study of TSR-022 (Cobolimab) in Combination With TSR-042 (Dostarlimab) for the Treatment of Advanced Hepatocellular Carcinoma

Status Recruiting

Clinical Trial Summary

TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) may stop the growth of tumor cells by allowing the immune system to attack the cancer. This phase II trial is studying how well TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) work in combination in treating patients with locally advanced or metastatic liver cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the objective response rate (ORR) as determined by RECIST v1.1 of advanced hepatocellular cancer (HCC) patients treated with TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody).

SECONDARY OBJECTIVES:

I. To determine the ORR as determined by the immune related Response Criteria (irRC), duration of response (DOR), time to progression (TTP), progression free survival (PFS), overall survival (OS), and alpha-fetoprotein (AFP) response of study participants.

II. To evaluate the safety profile of treated patients.

OUTLINE:

Patients receive TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 9 weeks. ;

Related Conditions & MeSH terms

• Adult Primary Liver Cancer
• Advanced Adult Primary Liver Cancer
• Liver Neoplasms
• Localized Unresectable Adult Primary Liver Cancer

• NCT number: NCT03680508
• Study type: Interventional
• Source: University of Hawaii
• Contact: Jared D Acoba, MD
• Phone: 8085318521
• Email: jacoba@hawaii.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: December 19, 2019
• Completion date: October 2025