Study on Trabectedin, Ipilimumab, and Nivolumab as First Treatment for Advanced Soft Tissue Sarcoma
Sponsor: Sarcoma Oncology Research Center, LLC
ClinicalTrials ID:NCT03138161
This clinical trial is testing a new combination of drugs, Trabectedin, Ipilimumab, and Nivolumab, to see if they are safe and effective as a first treatment for advanced soft tissue sarcoma. The study will first test different doses to find the safest one, then evaluate the treatment's effectiveness in more patients.
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Program Overview
The study aims to find the safest and most effective dose of a new drug combination for treating advanced soft tissue sarcoma. Initially, patients who have already received treatment will help determine the best dose. Later, patients who have not been treated before will receive the established dose to assess the treatment's overall safety and effectiveness.
Description
This study is divided into two phases. In Phase 1, researchers will test different doses of Trabectedin, given with Ipilimumab and Nivolumab, to find the safest dose. This phase involves treating small groups of patients and adjusting doses based on their reactions. Patients can continue treatment until their cancer progresses or they experience unacceptable side effects, for up to one year.
In Phase 2, more patients who have not been treated before will receive the safest dose found in Phase 1. This phase will help determine how well the treatment works in a larger group. Patients may continue treatment until their cancer progresses significantly or they experience unacceptable side effects, for up to one year.
After some treatment cycles, surgery may be recommended to remove or biopsy the tumor. If cancer remains, additional treatment cycles may be given after recovery from surgery. Tumor samples will be analyzed to understand how the treatment affects the cancer and immune cells.
The study involves regular monitoring and tests to ensure patient safety and to evaluate the treatment's impact on the cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of advanced soft tissue sarcoma that cannot be surgically removed or has spread.
- For Phase 1, must have received previous treatment; for Phase 2, must not have received previous treatment.
- Able to understand the study and sign a consent form.
- Willing to follow all study procedures and attend appointments.
- Have measurable cancer based on specific criteria.
- 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 blood tests.
- Have adequate blood cell counts without needing support.
- Women of childbearing potential must have a negative pregnancy test and all participants must agree to use effective contraception during and after the study.
Exclusion Criteria
- Have received certain immune therapies or drugs targeting T-cell pathways before.
- Have untreated brain metastases unless they have been treated and stable for at least 2 weeks.
- Have cancer in the brain's lining (carcinomatous meningitis).
- Have had recent cancer treatments or participated in another study within 2 weeks.
- Be pregnant or breastfeeding.
- Unable or unwilling to follow the study protocol.
- Have certain autoimmune diseases or require systemic immunosuppression.
- Have significant skin conditions affecting large areas.
- Have inflammatory bowel disease or uncontrolled diarrhea.
- Have recent serious digestive issues or heart problems.
- Have severe or uncontrolled diseases or conditions that could affect participation.
- Test positive for hepatitis B, hepatitis C, or HIV.
- Have inadequate blood, kidney, or liver function based on specific tests.
- Have a history of heavy alcohol use or certain hormonal disorders.
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