NCT05546827

Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sinonasal Melanoma
• Anorectal Melanoma

Interventions

Type	Name	Description
PROCEDURE	Surgical resection	Surgical resection after receiving neodjuvant combination immunotherapy followed by radiation therapy.

Timeline

• Start date: 2022-09-23
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2022-09-21
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States