Study on Talimogene Laherparepvec, Nivolumab, and Trabectedin for Treating Sarcoma

Sponsor: Sarcoma Oncology Research Center, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03886311

Provider View

This clinical trial is testing a combination of three drugs—Talimogene Laherparepvec, Nivolumab, and Trabectedin—as a treatment option for advanced sarcoma, including desmoid tumors and chordoma. The study aims to see if these drugs can help control the disease and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring the use of three drugs—Talimogene Laherparepvec, Nivolumab, and Trabectedin—as a treatment for advanced sarcoma, including desmoid tumors and chordoma. The main goal is to see if this combination can help patients live longer without the disease getting worse over a year. Researchers will also look at how well the tumors respond to the treatment, how long the response lasts, and if the treatment can make tumors that couldn't be removed by surgery become operable. The study will also monitor any side effects related to the treatment. Forty adults with advanced sarcoma will participate in this study.

Description

This clinical trial is testing a combination of three drugs—Talimogene Laherparepvec, Nivolumab, and Trabectedin—as a treatment for advanced sarcoma, including desmoid tumors and chordoma. The main goal is to see if this combination can help patients live longer without the disease getting worse over a year. Researchers will also look at how well the tumors respond to the treatment, how long the response lasts, and if the treatment can make tumors that couldn't be removed by surgery become operable. The study will also monitor any side effects related to the treatment.

The study will involve 40 adults with advanced sarcoma. Participants will receive the combination treatment and undergo regular scans to monitor their response. The study will also explore how the treatment affects the immune cells in the tumor environment.

Participants must be at least 18 years old, have a confirmed diagnosis of advanced sarcoma, and meet other health criteria to join the study. They must also agree to follow the study procedures and attend all required visits.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced sarcoma, including desmoid tumor and chordoma, that cannot be removed by surgery or has spread.
  • Be able to understand the study and sign a consent form.
  • Be willing to follow all study procedures and attend all visits.
  • Have not received treatment for sarcoma before or have measurable disease if previously treated.
  • Have at least one tumor that can be injected with Talimogene Laherparepvec.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 3 months.
  • Have acceptable liver and kidney function based on specific blood tests.
  • Have adequate blood cell counts.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 5 months after the last dose. Men must agree to use contraception for 7 months after the last dose.

Exclusion Criteria

  • Have active cancer that has spread to the brain, unless previously treated and stable.
  • Have an active autoimmune disease requiring treatment.
  • Have significant immunosuppression or are taking high doses of steroids.
  • Have active herpes skin lesions or complications from HSV-1 infection.
  • Require regular treatment with anti-herpes drugs.
  • Have received Talimogene Laherparepvec or similar treatments before.
  • Have received a live vaccine within 28 days before the study.
  • Have had recent cancer treatments or major surgery without recovery.
  • Are participating in another clinical trial or have recently finished one.
  • Have active hepatitis B or C, or HIV infection.
  • Have had another cancer in the past 5 years, with some exceptions.
  • Are allergic to any of the study drugs.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Are unwilling to use effective contraception during the study and for a specified time after.
  • Are unwilling to minimize exposure to individuals at higher risk for HSV-1 complications during and after treatment.

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