Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure

Sponsor: CatalYm GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07219459

Patient View

This Phase 2b trial evaluates visugromab with nivolumab and a TKI versus placebo and a TKI in unresectable/metastatic HCC post anti-PD-(L)1 failure. Eligible participants have Child-Pugh A liver function, ECOG ≤1, and prior CPI treatment. Interventions include visugromab and nivolumab IV every 3 weeks, and a TKI orally, with a safety run-in and randomized treatment arms.

Patient Parameters

Program Overview

This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and a TKI compared to double placebo and a TKI in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach.
  • Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment.
  • Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period.
  • Age ≥ 18 years on the day of signing the informed consent.
  • Life expectancy of at least 3 months as assessed by the Investigator.
  • ECOG performance status ≤1.
  • Child-Pugh score of A6 or better.

Main

Exclusion Criteria

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma.
  • More than 1 line of prior systemic treatment for unresectable or metastatic HCC.
  • Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP.
  • Expected to require any other form of antineoplastic therapy during the trial.
  • Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction.
  • Known history of other prior malignancy unless participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
  • Known or detected clinically active central nervous system (CNS) involvement by HCC or other tumors.
  • Have one of the following cardiovascular risk factors: myocardial infarction, peri/myocarditis, or history of ischemic stroke in the past 3 months before planned treatment start, uncontrolled heart failure, uncontrolled ventricular arrhythmia, QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex.
  • An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start.
  • Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.
  • Chronic systemic corticosteroid treatment for other reasons.
  • Prior liver or other organ transplantation.

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