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

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

FACILITYZIPCITYSTATE
Enable Medicine (Specimen Analysis Only)94025Menlo ParkCalifornia
Stanford University Medical Center94305-5408StanfordCalifornia
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
MD Anderson Cancer Center (Data Analysis Only)77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.