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A Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Liver Cancer who have never been been Treated with Immuno-oncology Therapy after Prior Treatment with Tyrosine Kinase Inhibitors
EU CTIS ID: 2023-503519-13-00
What this study is testing
To evaluate the efficacy of relatlimab in combination with nivolumab relative to nivolumab monotherapy in IO therapy-naive participants after prior treatment with TKI therapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Male and female participants must be ≥ 18 years at the time of informed consent.
- - Participants with histologic confirmed advanced/metastatic 2L or 3L HCC.
- - Participants with pre-treatment tumor tissue sample with evaluable LAG-3 expression level by IHC. Participants with indeterminate or unevaluable LAG-3 status results will not be permitted to receive study treatment or randomize to a treatment arm.
- - Participants who have experienced progression that was demonstrated radiographically on or after one or two prior TKI therapies without prior exposure to IO agents.
- - Child-Pugh score of 5 or 6 points (ie, Child-Pugh A).
- - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
You likely can't join if
- - Women who are pregnant or breastfeeding
- - Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
- - Participants with uncontrolled or significant cardiovascular disease.
- - Prior organ allograft or allogeneic bone marrow transplantation.
- - Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- - Participants with symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Brazil
- Korea, Republic of
- Singapore
- Argentina
- Chile
- Turkey
- Japan
- Taiwan
- New Zealand
- China
- Australia
- Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Brazil; Korea, Republic of; Singapore; Argentina; Chile and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.