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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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