NCT02977052

Optimal Neo-adjuvant Combination Scheme of Ipilimumab and Nivolumab

Multicenter Phase 2 Study to Identify of the Optimal Neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label three-arm phase 2 trial (including a Simon stage 2 design) consisting of 90 stage III melanoma patients randomized 1:1:1 to receive either 2 courses 3 mg/kg ipilimumab + 1 mg/kg nivolumab every 3 weeks (Arm A), 2 courses 1 mg/kg ipilimumab + 3 mg/kg nivolumab every 3 weeks (Arm B), or 2 courses ipilimumab 3 mg/kg, directly followed by 2 courses nivolumab 3 mg/kg every 2 weeks (Arm C). All three treatment arms are applied prior to surgery at week 6, 30 patients per arm. Patients will be stratified according to treatment center. An interim analysis will be performed after 13 patients have been included in each arm, thus in total 39 patients have been included. PRADO extension cohort The trial will enroll in total about 100-110 melanoma patients with macroscopic stage III disease (RECIST measurable disease); inclusion will stop when 50 patients have achieved a pCR or pnCR. All patients will be treated (after marker placement into the largest lymph node metastasis) with the winner combination identified in the first part of the OpACIN-neo study which is 2 courses ipilimumab 1mg/kg + nivolumab 3mg/kg, q3wks. After 6 weeks of treatment, the patients will undergo only surgical resection of the marked index lymph node. Thereafter subsequent surgery and adjuvant therapy will be performed according to the achieved pathologic response.

Conditions

• Malignant Melanoma Stage III

Interventions

Type	Name	Description
DRUG	Ipilimumab
DRUG	Nivolumab
PROCEDURE	Surgery	Surgery will be done at 6 weeks
PROCEDURE	Blood for PBMCs	Blood will be taken for translational research on PBMCs
PROCEDURE	Biopsies	Biopsies will be taken during screening and at relapse.

Timeline

• Start date: 2016-11-24
• Primary completion: 2020-01-03
• Completion: 2025-06-01
• First posted: 2016-11-30
• Last updated: 2023-11-15

Locations

4 sites across 4 countries: Australia, Austria, Netherlands, Sweden