SarcomaEarly Phase 1NCT03463408
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
A Early Phase 1 study testing nivolumab and ipilimumab in people with Sarcoma, run by University of Rochester at 1 site in United States.
Trial summary
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- nivolumab and ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 19 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642-0001
About this study
Official title: Pilot Study of Neoadjuvant Dual Checkpoint Blockade With Concurrent Radiation in Resectable Soft Tissue Sarcoma
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Read the 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 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).
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.
Peripheral blood will be collected on day 1 pre-treatment, day 14, day 42, immediately prior to surgery, and at 3 month follow up. Peripheral blood will be sent for multidimensional flow analysis of changes in immune cell composition and markers of proliferation. Serum samples will be obtained before starting treatment and after surgery. Samples from select subjects whose resected tumors show significant response and whose tumors showed minimal response will be sent to Serametrix for serum profiling to detect antibody response to a panel of tumor-specific antigens.
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.
- Conditions
- Sarcoma
- Being tested
- nivolumab, ipilimumab
- Keywords
- Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabDrug
240 mg every 2 weeks
ipilimumabDrug
1 mg/kg every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event evaluation
Evaluate safety through assessment of adverse events throughout the course of treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start17 Jul 2018
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two cohort, open label, non-randomized study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrienne Victor, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463408
- Sponsor's protocol ID
- USAR17101
- Status last verified
- Aug 2026
- First submitted
- 24 Dec 2017
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32827353
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Neoadjuvant Dual Checkpoint Blockade With Concurrent Radiation in Resectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT03463408
- Acronym / sponsor ID
- USAR17101
- Conditions
- Sarcoma
- Keywords
- Sarcoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
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.
Peripheral blood will be collected on day 1 pre-treatment, day 14, day 42, immediately prior to surgery, and at 3 month follow up. Peripheral blood will be sent for multidimensional flow analysis of changes in immune cell composition and markers of proliferation. Serum samples will be obtained before starting treatment and after surgery. Samples from select subjects whose resected tumors show significant response and whose tumors showed minimal response will be sent to Serametrix for serum profiling to detect antibody response to a panel of tumor-specific antigens.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two cohort, open label, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy arm | Experimental | Drug: nivolumab, Drug: ipilimumabCohort 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nivolumab240 mg every 2 weeks | Drug | Immunotherapy arm |
| ipilimumab1 mg/kg every 6 weeks | Drug | Immunotherapy arm |
Primary outcome
Adverse Event evaluation
Time frame: 2 years
Evaluate safety through assessment of adverse events throughout the course of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 32827353Vatner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing nivolumab and ipilimumab in people with Sarcoma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event evaluation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.