Status:
ACTIVE_NOT_RECRUITING
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Lead Sponsor:
University of Rochester
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Detailed Description
A single institution two cohort, open label, non-randomized study of neoadjuvant nivolumab and ipilimumab with concurrent radiation followed by surgical resection. Cohort A will comprise adult soft t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03463408
Start Date
July 17 2018
End Date
August 1 2026
Last Update
August 11 2025
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642-0001