BridgeMD
Compares treatment options for Unresectable or Metastatic Hepatocellular Carcinoma
Official title Visugromab, Nivolumab and Lenvatinib Compared to Double Placebo and Lenvatinib in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure
ClinicalTrials.gov ID: NCT07219459
What this study is testing
What is Visugromab RDE (recommended dose for expansion)?
Visugromab RDE (recommended dose for expansion) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unresectable or metastatic hepatocellular carcinoma.
Also referred to as CTL-002.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Main
- 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...
- Age ≥ 18 years on the day of signing the informed consent.
You likely can't join if
- 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...
See the full eligibility criteria
- Main
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- Peoria, Illinois, United States
- Hanover, Lower Saxony, Germany
- Mainz, Rhineland-Palatinate, Germany
- Frankfurt, Germany
- Bologna, Italy
- Milan, Italy
- Ravenna, Italy
- Zaragoza, Aragon, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Barcelona, Catalonia, Spain
- Pamplona, Chartered Community of Navarra, Spain
- Madrid, Madrid, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Atlanta, Georgia, United States; Peoria, Illinois, United States; Hanover, Lower Saxony, Germany; Mainz, Rhineland-Palatinate, Germany; Frankfurt, Germany and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.