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
- Conditions
- Advanced Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10077738Term: Hepatocellular carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003151-38-PL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method