Trials / Active Not Recruiting
Active Not RecruitingNCT03680508
TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer
Phase II Study of TSR-022 (Cobolimab) in Combination With TSR-042 (Dostarlimab) for the Treatment of Advanced Hepatocellular Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- University of Hawaii · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Adult Primary Liver Cancer
- Advanced Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TSR-022 and TSR-042 | immunotherapy |
Timeline
- Start date
- 2019-12-19
- Primary completion
- 2026-03-06
- Completion
- 2027-10-01
- First posted
- 2018-09-21
- Last updated
- 2026-04-02
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03680508. Inclusion in this directory is not an endorsement.