M.D. Anderson Cancer Center
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
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.
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…
Surgical resection after receiving neodjuvant combination immunotherapy followed by radiation therapy.
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