Combination Therapy for Sarcoma

Recruiting at 13 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a combination of three drugs to treat adults with hard-to-treat sarcomas, especially a type called MPNST linked to NF1. The drugs work together to stop cancer growth and boost the immune system. The study aims to find out if this combination is safe and effective. The combination of panobinostat, venetoclax, and anti-CD40 has shown promise in preclinical models for inducing complete tumor remission.

Eligibility Criteria

Adults (18+ years) with specific sarcomas, including MPNST and no standard treatment options left. They must have measurable disease, be over 30 kg in weight, recovered from previous treatments' side effects, not used certain inhibitors or immunosuppressants recently, and have proper organ function. Women of childbearing potential must use effective birth control.

Inclusion Criteria

Patients must have a life expectancy of at least 12 weeks

I am 18 years old or older.

My cancer is a specific type of sarcoma in the soft tissue or bone.

Exclusion Criteria

I have severe lung problems or heart conditions.

History of allogeneic organ transplantation

Patients with severe and/or uncontrolled medical conditions

Treatment Details

Interventions

• Selumetinib (Kinase Inhibitor)

Trial Overview The trial is testing Selumetinib combined with a Bromodomain Inhibitor and Durvalumab on patients with refractory/unresectable sarcomas. It's an open-label phase 1/2 study where all participants receive the experimental drugs to see how well they work and what the side effects are.

Participant Groups

Group I: Phase 1 and 2 Study of Selumentinib, BI and Durvalumab Experimental Treatment 1 Intervention

Part A will be a phase 1 dose escalation study of the combination with selumetinib and BI, and, Part B will be phase 1 study combining the determined dose of selumetinib and BI from Part A with durvalumab. Part C will be a phase 2 study combining selumetinib, BI with durvalumab in MPNST patients at the recommended doses from part B. A Simon's two-stage design will be used in the phase 2 trial to determine the clinical benefit in patients with unresectable or metastatic NF associated MPNST.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+