Epacadostat + Pembrolizumab for Sarcoma

Recruiting in Palo Alto (17 mi)

Overseen bySandra D'Angelo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to test any good and bad effects of the combination therapy of epacadostat and pembrolizumab and to determine how well the combination therapy works in the treatment of patients with sarcoma.

Eligibility Criteria

Adults with advanced sarcoma who have tried at least one other treatment can join this trial. They must be in good health otherwise, able to consent, and willing to follow the study plan. A biopsy is needed unless it's too risky. Those without standard treatment options or refusing standard chemo are also eligible.

Inclusion Criteria

I am 18 years old or older.

My organs are working well enough for treatment.

You need to agree to have a tissue sample taken from your tumor before treatment begins. If it's too risky or impossible to do so, the principal investigator may decide to exempt you from this requirement.

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Participant Groups

The trial tests a combo of two drugs: Epacadostat, which blocks an enzyme that cancers use to hide from the immune system, and Pembrolizumab, an immunotherapy drug already used for some cancers. The goal is to see if together they work better for sarcoma.

4Treatment groups

Experimental Treatment

Group I: Vascular Sarcoma SubtypesExperimental Treatment2 Interventions

Including angiosarcoma and Epithelioid Hemangioendothelioma (EHE). Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

Group II: UPS, Liposarcoma or pleomorphic liposarcomaExperimental Treatment2 Interventions

Undifferentiated Pleomorphic Sarcoma (UPS) or Liposarcoma (dedifferentiated or pleomorphic liposarcoma) Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

Group III: OtherExperimental Treatment2 Interventions

Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

Group IV: LeiomyosarcomaExperimental Treatment2 Interventions

Epacadostat 100mg Twice daily Continuously days 1-21 of each 3 week cycle Oral Pembrolizumab 200mg Every 3 weeks Day 1 of each 3 week cycle IV infusion

Epacadostat is already approved in United States for the following indications:

🇺🇸 Approved in United States as Epacadostat for: