Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06526104
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tremelimumab — DRUG
    Priming dose of tremelimumab 300 mg IV once (Cycle 1, Day 1 only)
  • Durvalumab — DRUG
    Durvalumab 1500 mg IV on Day 1 of each 4-week cycle.

Study Details

This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.

Key Dates

Start date
Dec 2, 2024
Status verified
Jan 2026
Primary completion
Oct 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stride (Single T Regular Interval D) Arm
    Tremelimumab dosed once at the beginning of the first cycle, 300mg IV infusion and Durvalumab 1500mg IV dosed with the first dose of Tremelimumab and then once per cycle (every 4 weeks)

Primary Outcome Measure

Grade 3 or Higher Treatment Related Treatment Emergent-Adverse Events (TRTE-AEs) [ Time Frame: Baseline up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Health San AntonioSan AntonioTexas78229
Sukeshi Arora, MD
[email protected]
210-450-2872

Find similar trials in San Antonio, TX

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
UT Health San Antonio· San Antonio, TX

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