Axitinib + Nivolumab for Melanoma

Phase 2

Recruiting

Led By Alexander Shoushtari, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether the combination of axitinib and nivolumab is an effective and safe treatment for people with advanced or metastatic mucosal melanoma.

Who is the study for?

Adults with advanced mucosal melanoma that hasn't been treated before can join this trial. They should have a certain type of tumor, be in good enough health to perform daily activities (ECOG 0-2), and not be pregnant or breastfeeding. Participants must agree to use two contraception methods if applicable. People with severe allergies to the drugs, autoimmune diseases needing steroids, recent heart issues, or specific blood disorders cannot join.

What is being tested?

The study is testing whether axitinib combined with nivolumab is effective for treating advanced mucosal melanoma. Axitinib blocks cancer cell growth signals while nivolumab boosts the immune system's response against cancer cells. The hope is that together they work better than alone.

What are the potential side effects?

Possible side effects include allergic reactions, fatigue, high blood pressure from axitinib; and skin rash, liver inflammation, lung problems like pneumonitis from nivolumab. There may also be risks related to combining these medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

best objective response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Axitinib and Nivolumab for the Treatment of Mucosal MelanomaExperimental Treatment3 Interventions

This is a single center trial enrolling up to 20 total evaluable patients with unresectable primary or advanced mucosal melanomas arising from the head and neck, gastrointestinal, or genitourinary tract to receive frontline therapy with nivolumab IV 480mg q4 weeks plus axitinib 5mg PO twice daily. A Simon 2-stage design will be utilized. Upon progression with good tolerance, addition of stereotactive body radiation therapy (SBRT) or CTLA-4 blockade to continued nivolumab plus axitinib will be offered to patients depending on the type of progression. For patients with local or oligometastatic progression, stereotactic body radiotherapy (SBRT) will be added; for patients with progression in a site of prior radiotherapy or with multifocal or distant progression not amenable to SBRT, ipilimumab 1mg/kg IV q3 weeks for up to 4 doses will be added.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

axitinib

2016

Completed Phase 2

~2390

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~950