Study on Selumetinib and Bromodomain Inhibitor with Durvalumab for Treating Sarcomas

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05253131

Provider View

This clinical trial is testing a new combination of drugs, including Selumetinib, a Bromodomain Inhibitor, and Durvalumab, to see if they can help treat sarcomas that are difficult to remove or have returned after treatment. The study is divided into two phases, with the first phase open to all patients with these types of sarcomas and the second phase focusing on a specific type called NF1-associated MPNST.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment combination for sarcomas, which are a type of cancer that can occur in bones and soft tissues. The trial involves three drugs: Selumetinib, a Bromodomain Inhibitor, and Durvalumab. The study is divided into two phases. Phase 1 is open to all patients with sarcomas that have returned or are not responding to standard treatments. Phase 2 focuses on patients with a specific type of sarcoma called NF1-associated MPNST that cannot be removed by surgery or has spread. The study aims to find the best dose and see if the treatment is safe and effective.

Description

This study is testing a combination of three drugs—Selumetinib, a Bromodomain Inhibitor, and Durvalumab—to treat sarcomas that are hard to treat or have come back after treatment. The study is divided into two phases:

  • Phase 1: This part is open to all patients with sarcomas that have not responded to other treatments. It will determine the best dose of Selumetinib and the Bromodomain Inhibitor, and then combine them with Durvalumab.

  • Phase 2: This part focuses on patients with a specific type of sarcoma called NF1-associated MPNST. It will use the doses determined in Phase 1 to see if the treatment is effective and safe.

The study will enroll up to 41 participants, with 15-25 participants expected to join each year. The entire study is expected to take about three years, with an additional year of follow-up after the last participant joins.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and weigh more than 30 kg.
  • Have a life expectancy of at least 12 weeks.
  • For Phase 1: Have a confirmed diagnosis of certain types of sarcomas, such as MFH, rhabdomyosarcoma, or MPNST, that have not responded to standard treatments.
  • For Phase 2: Have NF1-associated MPNST that cannot be removed by surgery or has spread.
  • Must have measurable disease that can be tracked during the study.
  • Must have recovered from any previous cancer treatments.
  • Must meet specific blood count and organ function requirements.
  • Must agree to use effective birth control if of childbearing potential.
  • Women must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
  • Must be able to understand and agree to the study requirements.

Exclusion Criteria

  • Have another type of cancer that was treated and has been inactive for less than 5 years.
  • Have a history of leptomeningeal carcinomatosis.
  • Are currently receiving other cancer treatments.
  • Cannot swallow pills.
  • Have had an organ transplant.
  • Are using immunosuppressive medications, with some exceptions.
  • Have had recent major surgery.
  • Have severe or uncontrolled medical conditions, such as severe lung or heart problems.
  • Have active infections like tuberculosis, hepatitis B, or hepatitis C.
  • Have autoimmune or inflammatory disorders, with some exceptions.
  • Have certain eye conditions.
  • Are allergic to the study drugs or similar drugs.
  • Are unable or unwilling to follow the study protocol.

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