NCT05546827
Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma
Recruiting · Phase 2 · M.D. Anderson Cancer Center · registry updated 2026-09-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
Inclusion
- For all patients
- Evidence of mucosal tumor on clinical exam or imaging.
- No evidence of distant metastasis
- Patients must be planned for combination immunotherapy (e.g. ipilimumab and nivolumab or nivolumab and relatlimab).
- ECOG performance status ≤3.
- Age ≥18 years because melanoma is extremely rare in patients \<18 years of age and RT is considered high risk in this population due to risk of secondary malignancy and potentially growing tissues that may be adversely impacted by RT.
Exclusion
- Previous radiation therapy to the planned target area (sinonasal for Arm 1 and anorectal for Arm 2).
- Metastatic disease
- Pregnant women are excluded from this study because RT is a known teratogen.
- Patients who are less than 18 years of age because melanoma is extremely rare in this population and the treatment agent is a known carcinogen.