Irvine, CANCT07219459Now EnrollingIRB Ready

Unresectable or Metastatic Hepatocellular Carcinoma Clinical Trial in Irvine, CA

Access cutting-edge unresectable or metastatic hepatocellular carcinoma treatment through this phase 2 clinical trial at a research site in Irvine. Study-provided care at no cost to qualified participants.

Sponsored by CatalYm GmbH

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Expert Care in Irvine

Access unresectable or metastatic hepatocellular carcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related unresectable or metastatic hepatocellular carcinoma treatment provided free

Apply for This Irvine Location

Check if you qualify for this unresectable or metastatic hepatocellular carcinoma clinical trial in Irvine, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Irvine

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Irvine site if eligible
  4. 4Begin participation

About This Unresectable or Metastatic Hepatocellular Carcinoma Study in Irvine

This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and Lenvatinib compared to double placebo and Lenvatinib 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.

Sponsor: CatalYm GmbH

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Irvine?

Yes, this clinical trial (NCT07219459) has an active research site in Irvine, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Unresectable or Metastatic Hepatocellular Carcinoma Treatment Options in Irvine, CA

If you're searching for unresectable or metastatic hepatocellular carcinoma treatment options in Irvine, CA, this clinical trial (NCT07219459) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Irvine research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced unresectable or metastatic hepatocellular carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all unresectable or metastatic hepatocellular carcinoma clinical trials near you to find additional studies recruiting in your area.

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