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Immunotherapy

Pre-Operative Radiotherapy for Sinonasal Melanoma

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion an average of 1 year

Awards & highlights

Study Summary

This trial is testing if radiation therapy before surgery can improve outcomes for people with sinonasal melanoma.

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of Pathologic Response

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

~920

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,306 Total Patients Enrolled

Devarati Mitra, MDStudy ChairM.D. Anderson Cancer Center

Frequently Asked Questions

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

What is the total number of participants currently involved in this research study?

"Affirmative. According to clinicaltrials.gov, this research is currently accepting new participants for the trial that was originally published on September 23rd 2022 and modified on the same date. This study requires 40 individuals from a single clinic site."

Answered by AI

What potential hazards could be associated with Surgical resection?

"While no clinical data has been demonstrated to support the efficacy of surgical resection, there are some safety concerns that warrant a score of 2."

Answered by AI

Are there currently opportunities to join this endeavor?

"The research posted on clinicaltrials.gov discloses that this trial is still seeking volunteers to participate, after being first put up on September 23rd 2022 and recently revised the same day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRISM: Pre-Operative Radiotherapy and Immunotherapy for Sinonasal Melanoma

2022. "PRISM: Pre-Operative Radiotherapy and Immunotherapy for Sinonasal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546827.