Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Multicenter Phase 2 Study to Identify of the Optimal Neo-Adjuvant Combination Scheme of Ipilimumab and Nivolumab (OpACIN-neo)
Brief 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.


Options:
A: Arm Label: Sequential D + T, THEN Pembrolizumab; Type: EXPERIMENTAL; Interventions: Drug: Dabrafenib, Drug: Trametinib, Drug: Pembrolizumab | Arm Label: Concurrent D + T AND Pembrolizumab; Type: EXPERIMENTAL; Interventions: Drug: Dabrafenib, Drug: Trametinib, Drug: Pembrolizumab | Arm Label: Pembrolizumab ONLY; Type: EXPERIMENTAL; Interventions: Drug: Pembrolizumab | Intervention Type: DRUG; Name: Dabrafenib; Assigned to Arm(s): Concurrent D + T AND Pembrolizumab, Sequential D + T, THEN Pembrolizumab | Intervention Type: DRUG; Name: Trametinib; Assigned to Arm(s): Concurrent D + T AND Pembrolizumab, Sequential D + T, THEN Pembrolizumab | Intervention Type: DRUG; Name: Pembrolizumab; Assigned to Arm(s): Concurrent D + T AND Pembrolizumab, Pembrolizumab ONLY, Sequential D + T, THEN Pembrolizumab
B: Arm Label: GSK2118436; Type: EXPERIMENTAL; Interventions: Drug: GSK2118436 | Arm Label: Dacarbazine (DTIC); Type: ACTIVE_COMPARATOR; Interventions: Drug: Dacarbazine (DTIC) | Arm Label: Crossover; Type: EXPERIMENTAL; Interventions: Drug: GSK2118436 | Intervention Type: DRUG; Name: GSK2118436; Assigned to Arm(s): Crossover, GSK2118436 | Intervention Type: DRUG; Name: Dacarbazine (DTIC); Assigned to Arm(s): Dacarbazine (DTIC)
C: Arm Label: Arm A: 2 courses ipi 3 + nivo 1; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Arm Label: Arm B: 2 courses ipi 1 + nivo 3; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Arm Label: Arm C: 2 courses ipi 3 + 2 courses nivo 3; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Arm Label: PRADO extension cohort; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab, Drug: Nivolumab, Procedure: Surgery, Procedure: Blood for PBMCs, Procedure: Biopsies | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: DRUG; Name: Nivolumab; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: PROCEDURE; Name: Surgery; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: PROCEDURE; Name: Blood for PBMCs; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort | Intervention Type: PROCEDURE; Name: Biopsies; Assigned to Arm(s): Arm A: 2 courses ipi 3 + nivo 1, Arm B: 2 courses ipi 1 + nivo 3, Arm C: 2 courses ipi 3 + 2 courses nivo 3, PRADO extension cohort
D: Arm Label: Surgery; Type: OTHER; Interventions: Procedure: Immediate surgical resection of melanoma lesion(s) | Arm Label: Talimogene Laherparepvec; Type: EXPERIMENTAL; Interventions: Drug: Talimogene Laherparepvec | Intervention Type: DRUG; Name: Talimogene Laherparepvec; Assigned to Arm(s): Talimogene Laherparepvec | Intervention Type: PROCEDURE; Name: Immediate surgical resection of melanoma lesion(s); Assigned to Arm(s): Surgery

Answer: C