PRISAM: Pre-Operative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Melanoma

Phase 2

Recruiting

• Conditions: Sinonasal Melanoma; Anorectal Melanoma

• Registration Number: NCT05546827
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this clinical research study is to learn if pre-operative radiation therapy after starting immune checkpoint inhibition can help patients with sinonasal or anorectal melanoma have better outcomes

Detailed Description

To determine the rate of pathologic response (\<50% viable tumor or \>50% fibrosis) for non-metastatic sinonasal melanoma patients having surgical resection after receiving neoadjuvant combination immunotherapy followed by radiation therapy.

To determine the rate of pathologic response (\<50% viable tumor or \>50% fibrosis) for non-metastatic anorectal melanoma patients receiving neoadjuvant intent combination immunotherapy followed by radiation therapy.

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-21
• Study Start: 2022-09-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2028-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of Pathologic Response	through study completion an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States