Ipilimumab and Nivolumab Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma

Sponsor
European Institute of Oncology
Study ID
NCT06566391
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Nivolumab and Ipilimumab (sequential) for a total of four doses followed by Nivolumab

Study Details

This is open label, single arm study for pts with stage IIIB-IV melanoma, accordingly with AJCC staging criteria (8th ed.), with potentially resectable disease. Patients will receive every three weeks, four cycles of Nivolumab 3 mg/kg (over one 30 minutes infusion) and Ipilimumab 1 mg/kg (over 30 minutes infusion) with a 30 minute break between each infusion. Surgery will be performed after 4-6 weeks from the last dose. After 4-6 weeks from surgery, patients will receive Nivolumab 480 mg (over one 60 minutes infusion), every four weeks for six cycles. The duration of the trial is expected to be 12 months of accrual and approximately 24 months of follow-up after the end of adjuvant therapy.

Key Dates

Start date
Mar 5, 2019
Status verified
Feb 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + Nivolumab followed by Nivolumab
    Neoadjuvant therapy: Ipilimumab 1 mg/kg + Nivolumab 3mg/kg every 3 weeks for 4 cycles; Adjuvant therapy: Nivolumab 480 mg every 4 weeks for 6 cycles

Primary Outcome Measure

Percentage of pathological complete response (Efficacy) [ Time Frame: 12-16 weeks after Neoadjuvant therapy ]

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