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Checkpoint Inhibitor

Immunotherapy + Radiation for Sarcoma

Phase < 1

Waitlist Available

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intermediate to high grade sarcoma on biopsy, tumor > 5 cm in size by imaging

18 years or older

Must not have

Active autoimmune colitis

Autoimmune adrenal insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding immunotherapy to radiation therapy will improve outcomes in people with resectable soft tissue sarcoma.

Who is the study for?

Adults diagnosed with resectable soft tissue sarcoma, not pregnant or nursing, and able to consent. They must have a performance status allowing daily activity (ECOG 0-2), no HIV complications, agree to use effective contraception methods post-treatment, and be willing to undergo radiation therapy and surgery. Excluded are those with prior radiation in the area, certain autoimmune conditions or active hepatitis B/C, low blood counts or liver enzymes above normal limits.

What is being tested?

The trial is testing the combination of two immunotherapy drugs—ipilimumab and nivolumab—with neoadjuvant radiation therapy in patients who can surgically remove their soft tissue sarcoma. The goal is to see how well this combo works before surgery.

What are the potential side effects?

Ipilimumab and nivolumab may cause immune-related side effects like inflammation of organs (colitis), skin reactions, hormone gland problems (like thyroid issues), fatigue, infusion reactions, as well as potential risks associated with combining these drugs with radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sarcoma is aggressive and larger than 5 cm.

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I am 18 years old or older.

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I am willing to undergo radiation therapy before surgery.

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I am not pregnant or breastfeeding.

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My condition can be treated with surgery.

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I am able to get out of my bed or chair and move around.

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My soft-tissue sarcoma diagnosis was confirmed by a biopsy reviewed at URMC.

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I am recommended to have radiotherapy before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active inflammation of my colon due to an autoimmune condition.

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I have an autoimmune condition affecting my adrenal glands.

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I have active hepatitis B or C.

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I have never been treated with ipilimumab, nivolumab, or similar drugs.

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I have had radiation therapy on the area where my cancer is located.

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My cancer has spread to other parts of my body before starting treatment.

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My cancer is one of the specified sarcoma types.

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I have an active autoimmune disease.

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I have a condition where my pituitary gland does not produce enough hormones.

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I have lung disease with low oxygen levels, even with extra oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Event evaluation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immunotherapy armExperimental Treatment2 Interventions

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.

Group II: no immunotherapy armActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nivolumab

2016

Completed Phase 3

~5250

ipilimumab

2016

Completed Phase 3

~5470