Visugromab + Nivolumab + TKI for Liver Cancer

(GDFATHERHCC01 Trial)

Overseen By Gerda Vlasitz-Kocks, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CatalYm GmbH

Must not be taking: Metformin, Corticosteroids

Disqualifiers: Fibrolamellar HCC, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for liver cancer that cannot be surgically removed or has metastasized. The study compares a combination of visugromab, nivolumab (a cancer drug), and a tyrosine kinase inhibitor (TKI) against a standard TKI with a placebo. The researchers aim to determine if the new combination is more effective and safe for individuals whose previous treatment with an anti-PD-(L)1 drug was unsuccessful. Ideal participants are those with liver cancer who have already tried one anti-PD-(L)1 treatment but require another option. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants using metformin for type II diabetes and those on chronic systemic corticosteroids. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of visugromab and nivolumab was well-tolerated in earlier studies, with no major safety issues reported. A tyrosine kinase inhibitor (TKI) is a drug often used in cancer treatments and other conditions. This trial is in Phase 2, indicating that the treatment has already passed initial safety tests in humans. This phase focuses on understanding the treatment's effectiveness, while safety continues to be closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for liver cancer, which often include options like sorafenib or lenvatinib, the combination of Visugromab with Nivolumab and a Tyrosine kinase inhibitor (TKI) is unique because it targets the cancer in a multi-faceted way. Visugromab introduces a novel mechanism by engaging the immune system to better recognize and attack cancer cells, while Nivolumab, a known checkpoint inhibitor, releases the brakes on the immune system, enhancing its ability to fight the cancer. This combination, aided by the TKI, which blocks enzymes that promote cancer cell growth, offers a new, potentially more effective approach by attacking the cancer from multiple angles. Researchers are excited about the potential synergy of these treatments, which could lead to improved outcomes for patients who may not respond well to current options.

What evidence suggests that this trial's treatments could be effective for liver cancer?

This trial will compare two treatment approaches for liver cancer. In one arm, participants will receive a combination of Visugromab, Nivolumab, and a tyrosine kinase inhibitor (TKI). Research shows that using Visugromab, Nivolumab, and a TKI together may help treat liver cancer. Previous studies found that Nivolumab, when combined with chemotherapy or a TKI, worked well for patients with liver cancer related to hepatitis B. Visugromab and Nivolumab together have demonstrated safety, as they did not cause major health problems. Although specific data on this combination's effectiveness for liver cancer is limited, it has shown promise in treating advanced cancers. These findings offer hope for patients who haven't responded to initial treatments. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced liver cancer (HCC) that can't be surgically removed and has not responded to previous treatments including anti-PD-(L)1 drugs. Participants must have a stable liver function (Child-Pugh A). They cannot join if they've had certain other treatments or health conditions that the study outlines.

Inclusion Criteria

My liver functions well enough for treatment.

Life expectancy of at least 3 months as assessed by the Investigator

My liver cancer cannot be removed by surgery and cannot be cured.

Exclusion Criteria

I will not need any cancer treatment other than the trial's during its duration.

I have had a liver or other organ transplant.

I am on long-term steroids for another condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Run-In

Non-randomized safety run-in to assess initial safety of the treatment combination

up to 36 months

Randomized Treatment

Participants are randomized into two treatment arms: Arm A with Visugromab, Nivolumab, and TKI, and Arm B with TKI and double placebo

up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab
• Tyrosine kinase inhibitor (TKI)
• Visugromab

Trial Overview The study tests visugromab combined with nivolumab and a tyrosine kinase inhibitor (TKI), against a double placebo plus TKI, in patients whose liver cancer didn't improve after first-line therapy. It's randomized, meaning participants are assigned to groups by chance.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 3 Interventions

Visugromab (IV) + Nivolumab intravenous (IV) + TKI (PO)

Group II: Arm B Active Control 2 Interventions

TKI (PO) + saline (double-placebo) intravenous (IV)

Who Is Running the Clinical Trial?

CatalYm GmbH

Lead Sponsor

Trials

2

Recruited

300+

Citations

1. withpower.com withpower.com/trial/phase-2-carcinoma-hepatocellular-1-2026-849bf

Visugromab + Nivolumab + TKI for Liver Cancer · Info for ... This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and a TKI compared ...

2. trial.medpath.com trial.medpath.com/clinical-trial/faa10a4d837b1505/nct07219459-visugromab-nivolumab-tyrosine-kinase-inhibitor-metastatic-hepatocellular-carcinoma

Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI ... This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and a TKI compared ...

3. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/visugromab-nivolumab-combo-triumphs-in-advanced-cancer-battle/

Visugromab/Nivolumab Combo Triumphs in Advanced ... The combination of visugromab and nivolumab was well-tolerated, with no significant safety concerns reported.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7479184/

Clinical Outcomes and Prognosis Factors of Nivolumab ... Nivolumab combined with chemotherapy or TKI treatment is effective in patients with recurrent hepatitis B virus-related HCC.

5. linkedin.com linkedin.com/posts/catalym_esmo-catalym-presents-long-term-ph-12a-activity-7385951669202628608-08eD

CatalYm presents long-term ph 1/2a data, visugromab With pancreatic cancer's 5-year survival rate still only 13% and the disease expected to become the second leading cause of cancer deaths by ...

6. adisinsight.springer.com adisinsight.springer.com/trials/700387312

A Phase 2b, Randomized, Blinded Trial Investigating the ... This is a Phase 2b, randomized, blinded clinical trial investigating the efficacy and safety of visugromab in combination with nivolumab and ...

7. meddatax.com meddatax.com/clinical-trials/NCT07219459

Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI ... Study Results. Results pending. The study team has not published outcome measurements, participant flow, or safety data for this trial yet.