Study on Lurbinectedin, Ipilimumab, and Nivolumab for Soft Tissue Sarcoma
Sponsor: ERLINDA M GORDON
ClinicalTrials ID:NCT05876715
This clinical trial is testing a combination of three drugs—Lurbinectedin, Ipilimumab, and Nivolumab—to find the best dose and see if they can help treat soft tissue sarcoma, a type of cancer. The study involves giving these drugs through an IV and adjusting the doses to find the safest and most effective levels.
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Program Overview
The study aims to determine the safest and most effective doses of Lurbinectedin when combined with fixed doses of Ipilimumab and Nivolumab for treating soft tissue sarcoma. Participants will receive these medications through an IV, and the doses of Lurbinectedin will be gradually increased to find the best dose that patients can tolerate without severe side effects. The study will also monitor how well the treatment works in controlling the cancer.
Description
This clinical trial is divided into two phases. In Phase 1, researchers will test different doses of Lurbinectedin to find the highest dose that patients can safely tolerate. This involves gradually increasing the dose in small groups of participants and monitoring for any serious side effects. Participants will receive Lurbinectedin every three weeks, along with Ipilimumab every 12 weeks and Nivolumab every two weeks. The study will continue until the cancer progresses, side effects become unacceptable, or up to one year of treatment.
In Phase 2, once the best dose is determined, the study will focus on how effective the treatment is in controlling soft tissue sarcoma. Participants will continue to receive the treatment at the established dose levels.
Participants must meet specific health criteria to join the study, including having a confirmed diagnosis of soft tissue sarcoma that cannot be surgically removed or has spread to other parts of the body. They must also be in good overall health, with adequate liver and kidney function, and agree to use effective birth control during and after the study.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of locally advanced or metastatic soft tissue sarcoma.
- For Phase 1, must have received previous treatment; for Phase 2, can be newly diagnosed.
- Able to understand the study and sign a consent form.
- Willing to follow all study procedures and attend appointments.
- Have measurable disease according to specific criteria.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- 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 recent transfusions or growth factors.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
Exclusion Criteria
- Have untreated brain metastases unless they have been treated and are stable.
- Have cancer in the lining of the brain or spinal cord.
- Have received certain cancer treatments recently.
- Have participated in another drug study recently.
- Are pregnant or breastfeeding.
- Cannot comply with the study requirements.
- Have had previous treatment with similar immunotherapy drugs.
- Have received certain vaccines recently.
- Have autoimmune diseases or are on immunosuppressive therapy.
- Have significant skin conditions affecting large areas.
- Have inflammatory bowel disease or uncontrolled diarrhea.
- Have recent history of certain gastrointestinal conditions.
- Have heart failure or recent heart problems.
- Have severe or uncontrolled medical conditions.
- Have active hepatitis B or C, or HIV/AIDS.
- Have a history of heavy alcohol use.
- Have certain hormonal disorders.
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