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New hope for liver cancer: Triple-Drug combo trial launches

NCT ID NCT07219459

Disease control Sponsor: CatalYm GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This phase 2b trial tests whether adding visugromab and nivolumab to standard lenvatinib can help people with advanced liver cancer that has worsened after initial treatment. About 104 participants will receive either the triple combination or a placebo plus lenvatinib. The study aims to see if the new combo slows cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
visugromab (CTL-002) combined with nivolumab and lenvatinib
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced liver cancer who have stopped responding to initial therapy.
What could go wrong
This is a mid-stage trial with only 104 participants, so results may not apply to everyone. The added drugs may increase side effects without improving outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main 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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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Child-pugh A hepatocellular carcinoma Failure of first-line treatment that included an anti PD-(L)1 compound Failure of first-line treatment that included an approved anti PD-(L)1 compound Unresectable or metastatic hepatocellular carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asst Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

    Contact Email: •••••@•••••

  • Catalan Institute of Oncology, Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Hannover Medical School

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Hospital Clinic of Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • OSF St. Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Ospedale S.Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • Peidmont Healthcare, Inc

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Polyclinic S. Orsola-Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University Clinic of Navarra - Pamplona

    RECRUITING

    Pamplona, Chartered Community of Navarra, 31008, Spain

  • University Hospital Miguel Servet

    RECRUITING

    Zaragoza, Aragon, 50009, Spain

  • University Hospital Ramon y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • University Medical Center of Johannes Gutenberg University Mainz

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität

    RECRUITING

    Frankfurt, 60590, Germany

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