Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

NCT03463408 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: USAR17101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Conditions

Sarcoma

Keywords

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Adverse Event evaluation

  Evaluate safety through assessment of adverse events throughout the course of treatment

  2 years

Study Arms (2)

Immunotherapy arm

EXPERIMENTAL

Cohort A will comprise adult soft tissue sarcoma patents who consent to and receive ipilimumab + nivolumab concurrently with standard of care radiation. Ipilimumab will be given at a dose of 1 mg/kg every 6 weeks (total two doses) and nivolumab given as a flat dose of 240 mg every 2 weeks (total four doses). Standard surgical resection will be done 2 to 4 weeks after completion of radiotherapy. Accrual is expected to occur over 2 years. Follow up data will be collected for up to 3 years post-treatment.

Drug: nivolumab; Drug: ipilimumab

no immunotherapy arm

NO INTERVENTION

Cohort B will comprise patients eligible for the trial who do not wish to receive immunotherapy but consent to the same blood draws, surveys, and specimen analysis as Cohort A. Cohort B will serve as a non-randomized but pragmatic and clinically relevant control group. Standard surgical resection will be done 2 to 4 weeks after completion of radiotherapy. Accrual is expected to occur over 2 years. Follow up data will be collected for up to 3 years post-treatment.

Interventions

nivolumab DRUG

240 mg every 2 weeks

Immunotherapy arm

ipilimumab DRUG

1 mg/kg every 6 weeks

Immunotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with biopsy-proven soft-tissue sarcoma with confirmatory pathology review at University of Rochester Medical Center (URMC)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642-0001, United States

Location

Related Publications (1)

• Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.

  PMID: 32827353 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)

Model Details: two cohort, open label, non-randomized study

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: March 13, 2018
• Study Start: July 17, 2018
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-07

Locations

US (1)