Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

• Status: Active, not recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Ipilimumab; Nivolumab

Criteria

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 participating in this study, she should inform her treating physician immediately.

• Sexually active males must use at least two other accepted and highly-effective methods of contraception and/or agree to abstain from sexual intercourse for at least 7 months after the last dose of nivolumab and/or ipilimumab

• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion Criteria:

• Gastrointestinal stromal tumor, dermatofibrosarcoma protuberans, rhabdomyosarcoma, Ewing's sarcoma, low-grade sarcomas, osteosarcoma subtypes

• History of radiation to the affected area

• Evidence of metastatic disease prior to treatment

• Any history of prior therapy with ipilimumab or nivolumab, or any agent targeting PD-1, PD-L1 or CTLA-4.

• History of any the following:

• Active known or suspected autoimmune disease

• Active autoimmune colitis

• Autoimmune pan hypopituitarism

• Autoimmune adrenal insufficiency

• Known active hepatitis B or C

• Known active pulmonary disease with hypoxia defined as:

• Oxygen saturation < 85% on room air or

• Oxygen saturation < 88% despite supplemental oxygen

• No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration.

• Second active malignancy, not including localized basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with a history of other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of registration.

• Absolute neutrophil count (ANC) <= 1,500/mm^3

• Platelet count <= 100,000/mm^3

• AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) => 2 x upper limit of normal (ULN)

• Thyroid stimulating hormone (TSH) outside of normal limits; supplementation is acceptable to achieve a TSH within normal limits; in patients with abnormal TSH if free T4 is normal and patient is clinically euthyroid, patient is eligible.

• Life expectancy under 5 years.