Optimal Neo-adjuvant Combination Scheme of Ipilimumab and Nivolumab
Status:
Active, not recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
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.