Ipilimumab and Nivolumab as Adjuvant Treatment of Mucosal Melanoma

Conditions

• Mucosal Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — DRUG
  1mg/kg
• Nivolumab — DRUG
  3mg/kg
• Nivolumab — DRUG
  480mg

Study Details

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.

Key Dates

Start date

Sep 12, 2017

Status verified

Dec 2022

Primary completion

Sep 15, 2022

Completion

Sep 30, 2023

Study Design

Enrollment

36 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ipilimumab (1 mg/kg) + Nivolumab (3 mg/kg) IV
  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

Primary Outcome Measure

Assess Recurrence-free survival time (RFS) [ Time Frame: 1.5 years ]

Locations (7)

Find similar trials in Jacksonville, FL

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