Study on Epacadostat and Pembrolizumab for Patients with Advanced Sarcoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT03414229

This clinical trial is testing a combination of two drugs, epacadostat and pembrolizumab, to see if they can effectively treat patients with advanced sarcoma, a type of cancer. The study aims to understand both the benefits and side effects of this treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the combination of epacadostat and pembrolizumab works in treating patients with advanced sarcoma, a type of cancer that has spread or cannot be removed by surgery. Researchers want to learn about the positive and negative effects of this treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Willing to provide written consent and follow the study protocol.
  • Have a confirmed diagnosis of advanced or metastatic sarcoma.
  • Have a good performance status, meaning you can carry out daily activities with little or no assistance.
  • Have received at least one previous treatment for sarcoma, unless there is no standard treatment available for your type of sarcoma.
  • Have measurable disease that can be tracked during the study.
  • Agree to a tumor biopsy before starting treatment, unless it's not safe or possible.
  • Have adequate organ function based on recent blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for 120 days after the last dose.
  • Men and women must agree to use effective birth control during the study and for 120 days after the last dose.

Exclusion Criteria

  • Have an uncontrolled illness or active infection requiring treatment.
  • Have active cancer spread to the brain or spinal cord, unless treated and stable.
  • Have significant immune system suppression or are taking high doses of steroids.
  • Have a history of autoimmune diseases requiring treatment in the past two years.
  • Have active HIV, Hepatitis B, or Hepatitis C infections.
  • Have received a live vaccine within 30 days before starting the study.
  • Are currently in another clinical trial or have recently received other cancer treatments.
  • Have a condition affecting drug absorption.
  • Are pregnant or breastfeeding, or planning to conceive during the study.
  • Have a known allergy to the study drugs.
  • Have a history of heart problems or abnormal heart rhythms.
  • Are taking certain medications that may interfere with the study drugs.
  • Have previously received similar treatments targeting the same pathways.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer Center10065New YorkNew York

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