RECRUITING

Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma

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Conditions

Hepatocellular Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase III, randomised, open-label, sponsor-blinded, 3-arm, multicentre, global study assessing the efficacy and safety of rilvegostomig in combination with bevacizumab with or without tremelimumab compared to atezolizumab in combination with bevacizumab. This study will be conducted in participants with advanced HCC who are not amenable to curative therapy or locoregional therapy

Official Title

A Phase III, Randomised, Open-label, Sponsor-blinded, Multicentre Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Quick Facts

Study Start:2025-05-06
Study Completion:2030-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06921785

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Locally advanced or metastatic and/or unresectable HCC
  2. * WHO/ECOG performance status of 0 or 1
  3. * BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A
  4. * At least one measurable target lesion
  5. * co-infected with HBV and HCV are not eligible
  6. * Adequate organ and bone marrow function measured during the screening period
  7. * Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.
  8. * Disease that is not amenable to curative surgical and/or locoregional therapies. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.
  1. * Any evidence of uncontrolled intercurrent diseases
  2. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
  3. * History of another primary malignancy
  4. * Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
  5. * Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.
  6. * History of active primary immunodeficiency or active infection
  7. * History of hepatic encephalopathy
  8. * Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
  9. * Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible
  10. * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
  11. * Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
  12. * Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
  13. * Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Phoenix, Arizona, 85054
United States
Research Site
Palo Alto, California, 94304
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
New Brunswick, New Jersey, 08901
United States
Research Site
Oklahoma City, Oklahoma, 73104
United States
Research Site
Arlington, Virginia, 22201
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2030-03-15

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2030-03-15

Terms related to this study

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma