Anti-TIM-3 + Anti-PD-1 Antibodies for Liver Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antiviral therapy for HBV, you must continue it. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination of Anti-TIM-3 and Anti-PD-1 antibodies for liver cancer?
Research shows that blocking TIM-3, an immune checkpoint, can enhance the body's ability to fight cancer, and combining it with PD-1 inhibitors may improve treatment outcomes. Studies in liver cancer models and other solid tumors suggest that targeting both TIM-3 and PD-1 can potentially overcome resistance to treatment and improve antitumor effects.12345
Is the combination of Anti-TIM-3 and Anti-PD-1 antibodies safe for humans?
How is the drug combination of Anti-TIM-3 and Anti-PD-1 antibodies unique for liver cancer treatment?
This drug combination is unique because it targets two immune checkpoint proteins, TIM-3 and PD-1, which are highly expressed in liver cancer tissues and associated with higher tumor grades. By blocking both proteins, this treatment aims to enhance the immune system's ability to fight cancer and potentially overcome resistance seen with other therapies that target only one checkpoint.12345
What is the purpose of this trial?
This trial is testing two drugs, cobolimab and dostarlimab, to help the immune system fight advanced or spreading liver cancer. The drugs work by blocking proteins that allow cancer cells to hide from the immune system, making it easier for the body to attack them.
Research Team
Jared D. Acoba
Principal Investigator
University of Hawaii
Eligibility Criteria
Adults with advanced liver cancer who haven't had systemic therapy can join this trial. They need good kidney function, controlled hepatitis if present, and at least one measurable tumor. They must not have severe lung conditions or be on recent immunosuppressants, live vaccines, or have other active cancers (with some exceptions). Pregnant women are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TSR-022 (cobolimab) and TSR-042 (dostarlimab) via IV on day 1, with courses repeating every 21 days in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- TSR-022
- TSR-042
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Hawaii
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School