Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma
Brief Summary: This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.


Options:
A: 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)
B: 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
C: Arm Label: Dabrafenib + Trametinib; Type: EXPERIMENTAL; Interventions: Drug: Dabrafenib, Drug: Trametinib | Arm Label: Dabrafenib + Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dabrafenib, Drug: Trametinib placebo | Intervention Type: DRUG; Name: Dabrafenib; Assigned to Arm(s): Dabrafenib + Placebo, Dabrafenib + Trametinib | Intervention Type: DRUG; Name: Trametinib; Assigned to Arm(s): Dabrafenib + Trametinib | Intervention Type: DRUG; Name: Trametinib placebo; Assigned to Arm(s): Dabrafenib + Placebo
D: Arm Label: Neoadjuvant treatment + Adjuvant treatment; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Adjuvant treatment; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Neo treat with patho response-driven Adju treat or observation; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Adjuvant treatment, Neo treat with patho response-driven Adju treat or observation, Neoadjuvant treatment + Adjuvant treatment | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Neo treat with patho response-driven Adju treat or observation, Neoadjuvant treatment + Adjuvant treatment

Answer: C