RBS2418 with tremelimumab and durvalumab for advanced unresectable liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2a, randomized study enrolls up to ~220 adults with radiologically or pathologically confirmed advanced, unresectable HCC who are eligible for the STRIDE regimen as first-line therapy. Participants receive either STRIDE alone or STRIDE plus RBS2418 at one of two dose levels (200 mg or 800 mg twice daily) in 28-day cycles for up to two years or until progression or withdrawal. The trial measures safety (AEs per NCI CTCAE v5.0), immunogenicity, and anti-tumor activity by RECIST 1.1, with regular imaging and laboratory monitoring. Pre-treatment tissue is required and participants must have ECOG 0-2 and a predicted life expectancy of at least 12 weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least 18 years of age on the day of signing informed consent.
2. Male and female participants with advanced, unresectable HCC who are eligible to receive STRIDE regimen as first line therapy.
3. Willing to submit a pre-treatment tissue sample (archival or fresh tissue if archival is not available).

Exclusion Criteria:

1. BCLC stage D disease at the time of screening or prior to first dose of RBS2418.
2. Child-Pugh class equal or higher than B8 at the time of screening or within 7 days prior to the first dose of study treatment.
3. Eligible for curative treatments (e.g., surgical resection, liver transplantation, or local ablation).
4. Evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.

Where it's running

• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• Vanderbilt-Ingram Cancer Center
  Nashville, Tennessee, United States Recruiting
• University of Texas Southwestern
  Dallas, Texas, United States Recruiting
• START Dallas Fort Worth
  Fort Worth, Texas, United States Recruiting

Study contacts

• Study coordinator: Riboscience Clinical Trials
• Email: clinicaltrials@riboscience.com
• Phone: 415-754-3182

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• STRIDE combination in advanced liver cancer: a first-line look at tremelimumab plus durvalumab

  This study tests tremelimumab plus durvalumab as a first-line treatment in adults with advanced or unresectable hepatocellular carcinoma to see how it affects liver health, quality of life, effectiveness, and safety.

  Recruiting at 17 sites AstraZeneca · Ancona and 23 other locations · NCT07607769

• Celecoxib with durvalumab and tremelimumab for advanced liver cancer

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  Recruiting at 3 sites Phase 2 Emory University · Atlanta, Georgia and 3 other locations · NCT07174570

• Y-90 internal liver radiation followed by tremelimumab and durvalumab for liver cancer with portal vein thrombosis

  This will test whether Y-90 selective internal radiation (SIRT) followed by tremelimumab and durvalumab helps people with non-resectable hepatocellular carcinoma that involves the portal vein.

  Recruiting Phase 2 Center Eugene Marquis · Grenoble and 5 other locations · NCT07122089

• Radiation therapy followed by immune therapy and surgery for hepatocellular carcinoma

  This trial tests whether adding durvalumab and tremelimumab to radiation therapy before surgery helps people with resectable liver cancer.

  Recruiting Phase 3 Hamilton Health Sciences Corporation · Hamilton, Ontario and 1 other locations · NCT07027436

• Photon radiotherapy plus tremelimumab and durvalumab for intermediate or advanced hepatocellular carcinoma

  This trial tests whether adding targeted photon radiotherapy to tremelimumab plus durvalumab helps people with unresectable intermediate or advanced (BCLC B or C) hepatocellular carcinoma respond better to treatment.

  Recruiting Phase 2 Chang Gung Memorial Hospital · Taoyuan City, Taiwan · NCT06999707

• Proton radiation with tremelimumab and durvalumab for BCLC stage B/C hepatocellular carcinoma

  This will test whether adding precise proton radiation to tremelimumab plus durvalumab helps people with unresectable BCLC stage B or C hepatocellular carcinoma.

  Recruiting Phase 2 Chang Gung Memorial Hospital · Taoyuan City, Taiwan · NCT06999694

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.