Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group
Brief Summary: This study will assess whether post-surgery therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA \[\> 1 mm metastasis\], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death-ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo as post-surgery therapy in Part 1. In Part 2, participants who experience a disease recurrence are eligible for pembrolizumab treatment (if treated with placebo in Part 1) or pembrolizumab rechallenge (if treated with pembrolizumab in Part 1). Participants deriving benefit from pembrolizumab will be given the opportunity to transfer to a pembrolizumab extension study, if available, upon study closure, and will be monitored following the standard of assessments of the pembrolizumab extension study.


Options:
A: Arm Label: Pembrolizumab; Type: EXPERIMENTAL; Interventions: Biological: pembrolizumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: BIOLOGICAL; Name: pembrolizumab; Assigned to Arm(s): Pembrolizumab | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
B: Arm Label: Arm A (nivolumab, surgery); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Biological: Nivolumab, Procedure: Therapeutic Conventional Surgery | Arm Label: Arm B (nivolumab, ipilimumab, surgery); Type: EXPERIMENTAL; Interventions: Biological: Ipilimumab, Other: Laboratory Biomarker Analysis, Biological: Nivolumab, Procedure: Therapeutic Conventional Surgery | Arm Label: Arm C (nivolumab, relatlimab, surgery); Type: EXPERIMENTAL; Interventions: Other: Laboratory Biomarker Analysis, Biological: Nivolumab, Biological: Relatlimab, Procedure: Therapeutic Conventional Surgery | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Arm B (nivolumab, ipilimumab, surgery) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm A (nivolumab, surgery), Arm B (nivolumab, ipilimumab, surgery), Arm C (nivolumab, relatlimab, surgery) | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Arm A (nivolumab, surgery), Arm B (nivolumab, ipilimumab, surgery), Arm C (nivolumab, relatlimab, surgery) | Intervention Type: BIOLOGICAL; Name: Relatlimab; Assigned to Arm(s): Arm C (nivolumab, relatlimab, surgery) | Intervention Type: PROCEDURE; Name: Therapeutic Conventional Surgery; Assigned to Arm(s): Arm A (nivolumab, surgery), Arm B (nivolumab, ipilimumab, surgery), Arm C (nivolumab, relatlimab, surgery)
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: Daromun plus Surgery and Adjuvant therapy (Arm 1); Type: EXPERIMENTAL; Interventions: Drug: Daromun, Procedure: Surgery, Drug: Adjuvant therapy | Arm Label: Surgery and adjuvant therapy (Arm 2); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Surgery, Drug: Adjuvant therapy | Intervention Type: DRUG; Name: Daromun; Assigned to Arm(s): Daromun plus Surgery and Adjuvant therapy (Arm 1) | Intervention Type: PROCEDURE; Name: Surgery; Assigned to Arm(s): Daromun plus Surgery and Adjuvant therapy (Arm 1), Surgery and adjuvant therapy (Arm 2) | Intervention Type: DRUG; Name: Adjuvant therapy; Assigned to Arm(s): Daromun plus Surgery and Adjuvant therapy (Arm 1), Surgery and adjuvant therapy (Arm 2)

Answer: A