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Immunotherapy + Radiation for Sarcoma
Study Summary
This trial is testing whether adding immunotherapy to radiation therapy will improve outcomes in people with resectable soft tissue sarcoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am willing to undergo blood tests for my study.My sarcoma is aggressive and larger than 5 cm.I have active inflammation of my colon due to an autoimmune condition.I have an autoimmune condition affecting my adrenal glands.I have active hepatitis B or C.I am willing to undergo radiation therapy before surgery.I have never been treated with ipilimumab, nivolumab, or similar drugs.My thyroid hormone levels are managed and within normal range with or without medication.Your doctor believes you have less than 5 years to live.I am 18 years old or older.I have no active cancer except for minor skin cancers or early-stage cancers that have been disease-free for over 3 years.I am not pregnant or breastfeeding.I have had radiation therapy on the area where my cancer is located.My cancer has spread to other parts of my body before starting treatment.My condition can be treated with surgery.My cancer is one of the specified sarcoma types.I am able to get out of my bed or chair and move around.I have an active autoimmune disease.My soft-tissue sarcoma diagnosis was confirmed by a biopsy reviewed at URMC.I agree to use two methods of contraception or abstain from sex for 7 months after my last dose.I have a condition where my pituitary gland does not produce enough hormones.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I have lung disease with low oxygen levels, even with extra oxygen.I have HIV with CD4+ cells over 350 and no detectable viral load.I am recommended to have radiotherapy before surgery.
- Group 1: no immunotherapy arm
- Group 2: Immunotherapy arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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