Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be … (NCT02500797) | Clinical Trial Compass
CompletedPhase 2
Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery
United States164 participantsStarted 2015-08-13
Plain-language summary
This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* PRE-REGISTRATION ELIGIBILITY CRITERIA:
* Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H\&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
* REGISTRATION ELIGIBILITY CRITERIA:
* Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review
* Patients must have histologically confirmed liposarcoma (LPS) (only dedifferentiated and pleomorphic; well differentiated not eligible), undifferentiated pleomorphic sarcoma (UPS)/malignant fibrous histiocytoma (MFH), or gastrointestinal stromal tumor (GIST)
* Measurable disease
* Locally advanced/unresectable or metastatic disease
* \>= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy
* No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
* No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =\< 28 days before study registration; no treatment with nitrosourea or mitomycin =\< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment
* Patients should have resolution of any toxic effects of prior therapy (excep…
What they're measuring
1
Number of Participants Who Achieved a Confirmed Response