Axitinib and Nivolumab for the Treatment of Mucosal Melanoma

ConditionMucosal Melanoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Initial study entry: Subjects must have at least 1 extracranial, unresectable, non-bony lesion that is measurable radiographically (based on RECIST 1.1).

Triplet arms: assessable disease required. RECIST 1.1 measurable disease is not required.

Disqualifiers

Active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (>10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

History of motor neuropathy considered to be of autoimmune origin (e.g., Guillain- Barre Syndrome, Myasthenia Gravis).

History of myocarditis.

History of, or any active evidence of non-infectious pneumonitis

Trial design

Design model

Single group

Treatments tested in this trial

Nivolumab and/or Ipilimumab
Drug
Combination of nivolumab 3mg/kg IV every 3 weeks with ipilimumab 1mg/kg or nivolumab 480mg IV every 4 weeks as monotherapy is considered standard of care for patients with unresectable locally advanced or metastatic mucosal melanoma.
Stereotactic Body Radiation Therapy (SBRT)
Radiation
SBRT upon local or oligometastatic progression. The prescribed dose of SBRT will be 30 Gy in 5 fractions.
axitinib
Drug
5mg twice daily

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Axitinib and Nivolumab for the Treatment of Mucosal MelanomaExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

best objective response

by RECIST 1.1.The Response Evaluation Criteria in Solid Tumors (RECIST)

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov

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