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Recruiting Phase 2 NCT05546827

Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

Trial Parameters

Condition Sinonasal Melanoma
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-09-23
Completion 2028-07-31
Interventions
Surgical resection

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

Eligibility Criteria

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

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