Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Nivolumab

Ipilimumab

Immunoglobulins

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cycles 1-4: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV Day 1 of each Cycle Each Cycle = 21 days

Cycles 5-15: Nivolumab IV 480 mg Day 1 of each Cycle Each Cycle = 28 days

Robert R. McWilliams, MD

This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.

Ipilimumab and Nivolumab Combination Administration

* Ipilimumab 1mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles
* Nivolumab 3mg/kg given IV Day 1 for 3 weeks (21 days), for 4 cycles

Nivolumab Alone Administration

* Nivolumab 480mg given IV Day 1 for 4 weeks (28 days), for 5-15 cycles

Nivolumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline.

Ipilimumab is to be administered as an approximately 30-minute IV infusion (± 10 minutes). At the end of the infusion, flush the line with a sufficient quantity of normal saline or 5% dextrose solution.

When both study drugs are to be administered on the same day, separate infusion bags and filters must be used for each infusion. Nivolumab is to be administered first. The nivolumab infusion must be promptly followed by a saline flush to clear the line of nivolumab before starting the ipilimumab infusion. The second infusion will always be ipilimumab, and will start at least 30 minutes after completion of the nivolumab infusion.

The dosing calculations should be based on the body weight from Cycle 1 Day 1. If the subject's weight on the day of dosing differs by \> 5% from the weight used to calculate the dose, the dose should be recalculated based on the current day of treatment weight. All doses should be rounded to the nearest milligram. There will be no dose modifications allowed.

Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252

Date the patient receives the first dose of study medication to the date of documentation of first disease recurrence or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma	NCT03241186	Mucosal Melanom...	Ipilimumab Nivolumab Nivolumab	18 Years -	Hoosier Cancer Research Network
Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma	NCT03241186	Mucosal Melanom...	Ipilimumab Nivolumab Nivolumab	18 Years -	Hoosier Cancer Research Network

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