Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma

Part of paid clinical trials in San Francisco, California.

Sponsor
Mary Feng, MD
Study ID
NCT04430452
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Hepatocellular Carcinoma
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8
  • Stage IVA Hepatocellular Carcinoma AJCC v8
  • Stage IVB Hepatocellular Carcinoma AJCC v8

Eligibility Criteria

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

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated RT
  • Tremelimumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing). In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.

Key Dates

Start date
Feb 4, 2022
Status verified
Dec 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: Durvalumab monotherapy + hypofractionated radiotherapy (RT)
    Participants undergo standard of care RT over 5 fractions once a day (QD) for 5 days. Within 3-10 days after completion of RT, participants receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II: Progression on prior programmed death-ligand 1 (PD-L1) checkpoint inhibitors
    Participants with progression on prior PD-L1 immune checkpoint inhibitor undergo standard of care hypofractionated radiotherapy (RT) over 5 fractions QD for 5 days and then receive a single, fixed dose of tremelimumab (300 mg IV) administered on Day 1, in combination with a fixed dose of durvalumab (1500 mg IV) every 28 days (+/-4 days for Cycles 2+), initiated within 3-10 days of completing RT, until confirmed radiographic progression or other criteria for discontinuation.
  • Experimental: Arm III: No previous PD-L1 checkpoint inhibitor therapy
    Participants without prior PD-L1 immune checkpoint inhibitor therapy undergo standard of care hypofractionated radiotherapy (RT) over 5 fractions QD for 5 days and then receive a single fixed dose of tremelimumab (300 mg IV) administered on Day 1, in combination with durvalumab at fixed dose of 1500 mg IV every 28 days (+/-4 days for Cycles 2+), initiated within 3-10 days of completing RT, until confirmed radiographic progression or other criteria for discontinuation.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Luchia Andemicael
[email protected]
[email protected]
877-827-3222
Mary Feng, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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