Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT05883644
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Participants will receive 1500 mg at Day 1 and later receive as monotherapy starting at Week 4 for every 4 weeks through IV infusion
  • Tremelimumab — DRUG
    Participants will receive single dose of 300 mg through IV infusion at Day 1

Study Details

This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.

Key Dates

First listed
Jun 1, 2023
Start date
Jun 27, 2023
Status verified
Apr 2026
Primary completion
Mar 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
111 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab plus Tremelimumab
    Participants will receive a single priming dose of Tremelimumab plus Durvalumab at Day 1 (Week 0), followed by Durvalumab monotherapy starting at Week 4 and continuing until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or any intervention discontinuation criteria.

Primary Outcome Measure

Incidence of grade 3 or 4 possibly related to treatment adverse events (PRAEs) [ Time Frame: From the date of first dose of IMP until 6 months after the initiation of study intervention ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteShreveportLouisiana71103-
Research SiteDetroitMichigan48202-

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