NCT06566391

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

Primary Ipilimumab and Nivolumab Combo-immunotherapy Followed by Adjuvant Nivolumab in Locally Advanced or Limited Metastatic Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study begins by establishing the patient's initial eligibility and signing of the ICF. Blood samples and tumor tissue obtained from core biopsy must be provided for biomarker analyses. All patients will receive every three weeks cycles of combined Nivolumab 3 mg/kg and Ipilimumab 1 mg/kg (sequential) for a total of four doses. Nivolumab and Ipilimumab will be administered sequentially, as two separate infusions, one 30 minute Nivolumab infusion and one 30 minute Ipilimumab infusion with a 30 minute break between each infusion. Surgery will be performed on Week 12-16 on known disease sites and in absence of G2-3-4 AE. The Adjuvant treatment will be performed on Week 16-22 from surgery; it will consist in Nivolumab 480 mg (over one 60 minutes infusion), every four weeks for six cycles. The Follow-up period will start 4 weeks after the end of adjuvant therapy. Patients will be followed for 24 months.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	Nivolumab and Ipilimumab (sequential) for a total of four doses followed by Nivolumab

Timeline

• Start date: 2019-03-05
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-08-22
• Last updated: 2024-08-22

Locations

1 site across 1 country: Italy