Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05546827

Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

Led by M.D. Anderson Cancer Center · Updated on 2026-05-04

40

Participants Needed

1

Research Sites

305 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Evidence of mucosal tumor on clinical exam or imaging
  • No evidence of distant metastasis
  • Planned combination immunotherapy (e.g., ipilimumab and nivolumab or nivolumab and relatlimab)
  • ECOG performance status 0 to 3
  • Age 18 years or older
  • Agreement to use adequate contraception if of child-bearing potential, including men for 6 months after radiation therapy
  • Patients with prior or concurrent malignancy allowed if it does not interfere with study treatments
  • Ability to understand and sign informed consent
  • For sinonasal melanoma: confirmed melanoma in nasal cavity or paranasal sinuses; surgical status assessed by Head and Neck Surgery; baseline skull base MRI unless contraindicated
  • For anorectal melanoma: confirmed melanoma in anorectal canal; surgical status assessed by surgical team; baseline rectal MRI unless contraindicated
Not Eligible

You will not qualify if you...

  • Previous radiation therapy to the planned target area (sinonasal or anorectal)
  • Metastatic disease
  • Pregnant women
  • Age under 18 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

Devarati Mitra, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma | DecenTrialz