NCT05384496 Axitinib and Nivolumab for the Treatment of Mucosal Melanoma

Trial Parameters

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Brief Summary

The researchers are doing this study to find out whether the combination of axitinib and nivolumab is an effective and safe treatment for people with advanced or metastatic mucosal melanoma that has not been treated before. The researchers think that a combination of axitinib and nivolumab may help people with this disease because both drugs target and block proteins that play a role in cancer cell survival and growth. The researchers think the drugs may be more effective if given in combination rather than on their own.

Eligibility Criteria

Inclusion Criteria: * Histologic diagnosis of unresectable or advanced mucosal melanoma arising from the head/neck (e.g. sinonasal, oral cavity, conjunctival), gastrointestinal (e.g. anorectal, esophageal), or genitourinary (e.g. vulvovaginal, urethral) sites. * Measurable disease 1. Initial study entry: Subjects must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1). 2. Triplet arms: assessable disease required. RECIST 1.1 measurable disease is not required. * Prior therapy 1. Initial study entry: No prior systemic therapy (adjuvant or metastatic). 2. Triplet arms: Only prior systemic therapy is nivolumab + axitinib on this trial. * ECOG performance status of 0-2. * Asymptomatic untreated brain metastases are allowed. Symptomatic brain metastases that have undergone local therapy with RT or surgery and have not required an increase in steroid dose in prior 2 weeks are allowed. * Screening laboratory parameters: 1. Whi

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