Study on Radiation Therapy Followed by Durvalumab With or Without Tremelimumab for Liver Cancer After Progression on PD-1 Inhibition

Sponsor: Mary Feng, MD

Sponsor score: 0

ClinicalTrials ID:NCT04430452

Provider View

This clinical trial is exploring whether adding durvalumab, with or without tremelimumab, after radiation therapy can help treat liver cancer that has spread and worsened after previous immunotherapy. The study aims to see if this combination can boost the immune system's ability to fight cancer.

Patient Parameters

Program Overview

This study is testing a treatment approach for advanced liver cancer that has spread and is getting worse after previous PD-1 inhibitor immunotherapy. The treatment involves using a type of radiation therapy that delivers higher doses over a shorter time, followed by the drug durvalumab, with or without another drug called tremelimumab. These drugs are designed to block signals that stop the immune system from attacking cancer cells, potentially helping to slow down or stop cancer growth. The study aims to find out if this combination works better than radiation therapy alone.

Description

The main goal of this study is to see how well the combination of durvalumab and tremelimumab works after radiation therapy in patients with advanced liver cancer that has progressed after previous PD-1 inhibitor treatment. Researchers will also look at the safety of these drugs and how effective they are in controlling the cancer.

Participants will be divided into two groups:

  • Group 1: Patients will receive radiation therapy followed by durvalumab. This treatment will be repeated every 28 days for up to 2 years unless the cancer progresses or side effects become unacceptable.

  • Group 2: Patients will receive radiation therapy followed by both durvalumab and tremelimumab. Durvalumab will be given every 28 days for up to 2 years unless the cancer progresses or side effects become unacceptable. If patients benefit from the treatment but later show signs of cancer progression, they may receive an additional dose of tremelimumab.

After completing the study treatment, patients will have follow-up visits every 2 months to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer that has worsened after previous PD-1 inhibitor treatment.
  • Have at least one measurable tumor that has not been treated with radiation or other local therapies.
  • Need radiation therapy for a specific reason, such as pain or risk of complications.
  • Have a Child Pugh score of A, B7, or B8, indicating certain liver function levels.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Be on appropriate antiviral therapy for hepatitis B with controlled viral load.
  • Have adequate organ function, including specific blood counts and liver and kidney function.
  • No contraindications to immune checkpoint inhibitor therapy or radiation therapy.
  • Be 18 years or older.
  • Have a life expectancy of at least 12 weeks.
  • Weigh more than 30 kg (66.1 pounds).
  • Women must be post-menopausal or have a negative pregnancy test if of childbearing potential.
  • Agree to use effective contraception during the study and for a specified period after treatment.
  • Be willing and able to comply with study requirements, including treatment and follow-up visits.
  • Provide informed consent to participate in the study.

Exclusion Criteria

  • Previous radiation to the tumor sites that could affect safety.
  • Previous treatment with certain immune therapies like CTLA-4 or PD-L1 inhibitors.
  • History of organ transplantation.
  • Severe side effects from previous PD-1 inhibitor treatment that required stopping the treatment.
  • Recent major surgery or other cancer treatments.
  • Unresolved side effects from previous cancer treatments, except for certain conditions like hair loss.
  • Participation in another clinical trial within the past 4 weeks.
  • Active autoimmune or inflammatory disorders, with some exceptions.
  • Uncontrolled illnesses or infections.
  • History of another primary cancer, with some exceptions.
  • Active infection, including tuberculosis or HIV.
  • Recent use of immunosuppressive medication, with some exceptions.
  • Recent receipt of a live vaccine.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Known allergy to study drugs or their components.
  • Previous participation in a durvalumab or tremelimumab study.
  • Any condition that makes participation unsuitable in the investigator's opinion.

Locations

FACILITYZIPCITYSTATE
University of California, San Francisco94143San FranciscoCalifornia

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