Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK2118436 in Combination With the MEK Inhibitor GSK1120212 in Subjects With BRAF Mutant Metastatic Melanoma
Brief Summary: This was an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK2118436 and GSK1120212 in combination. This study was designed in four parts. In Part A, the effect of repeat doses of GSK1120212 on the pharmacokinetics of single dose GSK2118436 was investigated prior to evaluating combination regimens. In Part B, the range of tolerated dose combinations was identified using a dose-escalation procedure. In Part C, different dose combinations of GSK2118436 and GSK1120212 were evaluated, based on results from the dose escalation cohorts. In Part D, the pharmacokinetics and safety of GSK2118436 administered as HPMC capsules alone and in combination with GSK1120212 was evaluated.


Options:
A: Arm Label: Arm Part A; Type: EXPERIMENTAL; Interventions: Drug: GSK2118436, Drug: GSK1120212 | Arm Label: Arm Part B; Type: EXPERIMENTAL; Interventions: Drug: GSK2118436 | Arm Label: Arm Part C; Type: EXPERIMENTAL; Interventions: Drug: GSK2118436, Drug: GSK1120212 | Intervention Type: DRUG; Name: GSK2118436; Assigned to Arm(s): Arm Part A, Arm Part B, Arm Part C | Intervention Type: DRUG; Name: GSK1120212; Assigned to Arm(s): Arm Part A, Arm Part C
B: Arm Label: Treatment (dabrafenib, trametinib, surgery); Type: EXPERIMENTAL; Interventions: Drug: Dabrafenib, Other: Laboratory Biomarker Analysis, Procedure: Therapeutic Conventional Surgery, Drug: Trametinib | Intervention Type: DRUG; Name: Dabrafenib; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery) | Intervention Type: PROCEDURE; Name: Therapeutic Conventional Surgery; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery) | Intervention Type: DRUG; Name: Trametinib; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery)
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: ipilimumab (MDX-010, BMS-734016) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Ipilimumab | Intervention Type: DRUG; Name: ipilimumab (MDX-010, BMS-734016); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): 3
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: MDX-010 (anti-CTLA4) monoclonal antibody, Biological: MDX-1379 (gp100) Melanoma Peptide Vaccine | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: MDX-010 (anti-CTLA4) monoclonal antibody | Intervention Type: DRUG; Name: MDX-010 (anti-CTLA4) monoclonal antibody; Assigned to Arm(s): 2, 3 | Intervention Type: BIOLOGICAL; Name: MDX-1379 (gp100) Melanoma Peptide Vaccine; Assigned to Arm(s): 1, 2

Answer: A