Study on Cabozantinib Combined with PD-1 and CTLA-4 Inhibition for Metastatic Soft Tissue Sarcoma
Sponsor: Washington University School of Medicine
ClinicalTrials ID:NCT04551430
This clinical trial is exploring whether adding two types of immunotherapy drugs to cabozantinib can improve treatment outcomes for patients with metastatic soft tissue sarcoma, a type of cancer that has spread and cannot be surgically removed.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if combining cabozantinib with two immunotherapy drugs, which block PD-1 and CTLA-4 proteins, can enhance the response in patients with metastatic soft tissue sarcoma. Researchers believe that starting treatment with cabozantinib may make the cancer more responsive to the immunotherapy drugs nivolumab and ipilimumab.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of metastatic or inoperable soft tissue sarcoma.
- Have tumors that can be measured by scans or physical exams.
- Have tried at least one but no more than two previous treatments, with the cancer worsening after the last treatment.
- Be 18 years or older.
- Be in good general health, with a performance status score of 0 or 1.
- Have normal blood and organ function based on specific medical tests.
- Be willing to use effective birth control during the study and for several months after the last treatment dose.
- Be able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Have a type of sarcoma driven by specific genetic changes, except for alveolar soft part sarcoma.
- Have previously been treated with cabozantinib or similar immunotherapy drugs.
- Have another type of cancer, unless it was treated and resolved at least two years ago.
- Have active brain metastases or other serious medical conditions that could interfere with the study.
- Be currently receiving other investigational treatments or medications that could affect the study.
- Have had recent major surgery or radiation therapy that has not fully healed.
- Be pregnant or breastfeeding, or planning to become pregnant during the study.
- Have received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University Medical Center | 94305 | Stanford | California |
| University of Colorado | 80045 | Aurora | Colorado |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Abramson Cancer Center at Pennsylvania Hospital | 19106 | Philadelphia | Pennsylvania |
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