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Immunotherapy
Pre-Operative Radiotherapy for Sinonasal Melanoma
Houston, TX
Phase 2
Recruiting
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of distant metastasis
Patients must be planned for combination immunotherapy (e.g. ipilimumab and nivolumab or nivolumab and relatlimab)
Must not have
Previous radiation therapy to the sinonasal area
Metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if radiation therapy before surgery can improve outcomes for people with sinonasal melanoma.
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Who is the study for?
This trial is for adults over 18 with sinonasal melanoma that can be seen on exams or imaging, and who are considered operable by a surgeon. They must agree to use contraception and have no distant metastasis. It's not for those previously treated with radiation in the nasal area, pregnant women, or anyone under 18.Check my eligibility
What is being tested?
The PRISM study tests if pre-operative radiation therapy improves outcomes for patients undergoing surgery for sinonasal melanoma. Participants will also receive combination immunotherapy (like ipilimumab and nivolumab) as part of their treatment plan.See study design
What are the potential side effects?
Potential side effects include typical risks associated with radiation therapy such as skin irritation, fatigue, nausea, and potential impact on nearby organs. Immunotherapies may cause immune-related reactions affecting various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to distant parts of my body.
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I am scheduled for combination immunotherapy treatment.
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My scans or exams show a tumor in my sinus area.
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I am capable of limited self-care.
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A surgeon has assessed my condition as operable or inoperable.
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My melanoma is in my nose or sinuses.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy to my nose or sinus area.
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My cancer has spread to other parts of my body.
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I am not pregnant, as the treatment could harm an unborn baby.
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I am 18 years or older.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Surgical resectionExperimental Treatment1 Intervention
Patients will have surgical resection after receiving neodjuvant combination immunotherapy followed by radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical resection
2021
Completed Phase 2
~1740
Find a Location
Closest Location:M D Anderson Cancer Center· Houston, TX· 574 miles
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,098 Previous Clinical Trials
1,812,519 Total Patients Enrolled
Devarati Mitra, MDStudy ChairM.D. Anderson Cancer Center