Study on Talimogene Laherparepvec (T-VEC) and Pembrolizumab for Treating Advanced Sarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT03069378
This clinical trial is testing a combination of two treatments, T-VEC and pembrolizumab, to see how well they work together in treating patients with advanced or spreading sarcoma.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to find out how effective the combination of two treatments, talimogene laherparepvec (T-VEC) and pembrolizumab, is in treating patients with sarcoma that has spread or cannot be removed by surgery.
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 sarcoma that is either metastatic (spread to other parts of the body) or locally advanced and cannot be surgically removed.
- For specific types of sarcoma, such as undifferentiated pleomorphic sarcoma, myxofibrosarcoma, epithelioid sarcoma, or cutaneous angiosarcoma, patients must have these specific subtypes.
- Must have at least one tumor that can be injected, measuring at least 10 mm in diameter. Bone lesions are not eligible unless they have a soft tissue component that can be injected.
- Must have had at least one prior treatment for sarcoma, unless there is no standard treatment available for their specific type of sarcoma.
- Must be in good overall health with a performance status score of 0 or 1.
- Must have adequate organ function as determined by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
Exclusion Criteria
- Have uncontrolled illness, such as an active infection or heart failure, within the last 6 months.
- Have active cancer in the brain or spinal cord, unless previously treated and stable.
- Have significant immune system suppression or are taking high doses of steroids.
- Have a history of autoimmune diseases that required treatment in the last 2 years.
- Have active herpes infections or require regular anti-herpes medication.
- Have active hepatitis B or C, or tuberculosis.
- Are pregnant, breastfeeding, or planning to become pregnant or father a child during the study.
- Are not willing to use effective birth control during the study and for a few months after.
- Have a history of severe allergic reactions to the study drugs.
- Have had recent cancer treatments or surgery and have not fully recovered.
- Are currently participating in another clinical trial or have recently participated in one.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Have another active cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Enable Medicine (Specimen Analysis Only) | 94025 | Menlo Park | California |
| Stanford University Medical Center | 94305-5408 | Stanford | California |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| MD Anderson Cancer Center (Data Analysis Only) | 77030 | Houston | Texas |
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