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Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

NCT05546827•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•RT is a known teratogen. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (refer to MDA Policy CLN 1114) This includes all female patients, between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
•Postmenopausal (no menses in greater than or equal to 12 consecutive months).
•History of hysterectomy or bilateral salpingo-oophorectomy.
•Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
+12 more criteria

Exclusion Criteria

•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.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

September 23, 2022

Primary Completion Date

July 31, 2028

Completion Date

July 31, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Sinonasal MelanomaAnorectal Melanoma

Interventions

Surgical resection

PROCEDURE

Contacts

Devarati Mitra, MD

CONTACT

(713) 563-1339 dmitra@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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