Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
United States14 participantsStarted 2018-07-17
Plain-language summary
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with biopsy-proven soft-tissue sarcoma with confirmatory pathology review at University of Rochester Medical Center (URMC)
* 18 years or older.
* Able to provide informed consent.
* Resectable disease per surgical evaluation.
* Neoadjuvant/preoperative radiotherapy has been recommended
* Intermediate to high grade sarcoma on biopsy, tumor \> 5 cm in size by imaging
* Willing to have blood draws for flow cytometry and Serametrix analysis.
* Willing to receive neoadjuvant radiation therapy and subsequent surgical resection.
* Patients with known human immunodeficiency virus (HIV) are eligible if the lymphocytes \> 350 CD4+ cells and no detectable viral load.
* Women of childbearing potential (defined as any woman, who 1) has not undergone tubal ligation, a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months or has had menses at any time in the preceding 24 consecutive months):
* Must not be pregnant or nursing
* Must have a negative pregnancy test done within 7 days prior to registration as well as within 72 hrs. prior to receiving first dose of study medication
* Women of childbearing potential must use at least two other accepted and highly-effective methods of contraception and/or agree to abstain from sexual intercourse for at least 5 months after the last dose of nivolumab and/or ipilimumab.
* Should a woman become pregnant or suspect she is pregnant while she is pa…