← Back to Search

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

Willing to have blood draws for flow cytometry and Serametrix analysis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am willing to undergo blood tests for my study.

Select...

My sarcoma is aggressive and larger than 5 cm.

Select...

I am 18 years old or older.

Select...

I am willing to undergo radiation therapy before surgery.

Select...

I am not pregnant or breastfeeding.

Select...

My condition can be treated with surgery.

Select...

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

Select...

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

Select...

I agree to use two methods of contraception or abstain from sex for 7 months after my last dose.

Select...

I have HIV with CD4+ cells over 350 and no detectable viral load.

Select...

I am recommended to have radiotherapy before surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Event evaluation

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

ipilimumab

2016

Completed Phase 3

~5520

nivolumab

2016

Completed Phase 3

~4960

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

834 Previous Clinical Trials

518,269 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03463408 — Phase < 1

Sarcoma Research Study Groups: Immunotherapy arm, no immunotherapy arm

Sarcoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03463408 — Phase < 1

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03463408 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the population size of this clinical experiment?

"This research initiative is no longer recruiting participants. Initially posted on July 17th, 2018 and last edited November 3rd 2021, this clinical trial has come to a close. If you are searching for other studies, there currently 444 trials enrolling patients with sarcoma and 764 admitting those treated with ipilimumab."

Answered by AI

Are there any openings left in this clinical experiment for volunteers?

"At this juncture, registration for this trial is closed. It was initially posted on July 17th 2018 and its most recent update happened November 3rd 2021. If you are examining other trials, there are currently 444 studies permitting enrolment of sarcoma sufferers and 764 investigations recruiting participants that take ipilimumab."

Answered by AI

What therapeutic purpose is ipilimumab typically used for?

"ipilimumab is typically prescribed to patients that have already received anti-angiogenic therapy. Its efficacy has also been documented in cases of malignant neoplasms, unresectable melanoma and squamous cell carcinoma."

Answered by AI

What other research has been conducted regarding the effectiveness of ipilimumab?

"Currently, there are 764 clinical trials of ipilimumab in progress with 87 taking place at Phase 3. Pittsburgh is a hub for these studies however they can be found across 44199 locations worldwide."

Answered by AI

Recent research and studies

Pediatric Blood & CancerJournal

Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges

Vatner, Ralph, Charles D. James, Vythialingam Sathiaseelan, Kathryn M. Bondra, John A. Kalapurakal, and Peter J. Houghton. 2020. “Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.28439.

Pediatric Blood & CancerJournal

Radiation Therapy and Molecular‐targeted Agents in Preclinical Testing for Immunotherapy, Brain Tumors, and Sarcomas: Opportunities and Challenges

clinicaltrials.govStudy

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Adrienne Victor 2018. "Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03463408.

All > Sarcoma > Soft Tissue Sarcoma