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Clinical Trials/EUCTR2018-003151-38-PL
EUCTR2018-003151-38-PL
Active, not recruiting
Phase 1

A Phase 2, Randomized, Open-label Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Hepatocellular Carcinoma who are Naive to IO Therapy but Progressed on Tyrosine Kinase Inhibitors - Phase 2 study of relatlimab and nivolumab in IO-naive 2nd/3rd-line HCC

Bristol-Myers Squibb International Corporation0 sites250 target enrollmentDecember 17, 2020
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DrugsOpdivo (100 mg/10 ml)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
250
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 17, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Male and female participants must be \= 18 years at the time of
  • •informed consent.
  • •\- Participants with histologic confirmed advanced/metastatic 2L or 3L
  • •\- 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

Exclusion Criteria

  • •\- 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.

Outcomes

Primary Outcomes

Not specified

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