Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001)
Brief Summary: The present study has 5 parts. In Parts A and A1, the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated from 1 to 10 mg/kg to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically- or cytologically-confirmed diagnosis of any type of carcinoma or melanoma (MEL) by evaluating the Dose Limiting Toxicities (DLTs). Following completion of the dose escalation, additional patients will be enrolled in Part A2 to further define pharmacokinetic characteristics. Part B of the study will investigate the safety, tolerability, and efficacy of pembrolizumab (2 mg/kg and 10 mg/kg) in participants with advanced or metastatic MEL and compare every 2 week dosing (Q2W) to every 3 week dosing (Q3W). Part C of the study will investigate the safety, tolerability, and efficacy of pembrolizumab administered at 10 mg/kg Q3W in participants with non-small cell lung carcinoma (NSCLC) that is locally advanced or metastatic. Part D of the study will investigate the low and high doses of study drug identified in Parts A and B (2 mg/kg and 10 mg/kg) administered Q3W in participants with advanced or metastatic MEL. Part E (closed with Amendment 7) was planned to investigate low, medium, and high doses of pembrolizumab in combination with standard chemotherapy in participants with locally advanced or metastatic NSCLC. Part F will investigate low and high doses of pembrolizumab (2 mg/kg and 10 mg/kg) administered Q2W or Q3W in treatment-naive and previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene expression. The primary hypotheses are the following: that pembrolizumab will have acceptable safety and tolerability; that pembrolizumab will show a clinically meaningful response rate (RR) or disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not) and NSCLC, and that pembrolizumab will show a more clinically meaningful RR in participants with either cancer whose tumors express PD-L1.


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: Bosentan; Type: EXPERIMENTAL; Interventions: Drug: Bosentan | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Bosentan; Assigned to Arm(s): Bosentan | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: 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)
D: Arm Label: Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: MEL: Pembrolizumab 10 mg/kg Q2W (Part B); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 2 mg/kg Q3W (Part E-Not Enrolled); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 5 mg/kg Q3W (Part E-Not Enrolled); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Arm Label: NSCLC: Pembrolizumab 10 mg/kg Q3W (Part E-Not Enrolled); Type: EXPERIMENTAL; Interventions: Biological: Pembrolizumab | Intervention Type: BIOLOGICAL; Name: Pembrolizumab; Assigned to Arm(s): MEL: Pembrolizumab 10 mg/kg Q2W (Part B), MEL: Pembrolizumab 10 mg/kg Q3W (Parts B+D), MEL: Pembrolizumab 2 mg/kg Q3W (Parts B+D), NSCLC: Pembrolizumab 10 mg/kg Q2W (Part F), NSCLC: Pembrolizumab 10 mg/kg Q3W (Part E-Not Enrolled), NSCLC: Pembrolizumab 10 mg/kg Q3W (Parts C+F), NSCLC: Pembrolizumab 2 mg/kg Q3W (Part E-Not Enrolled), NSCLC: Pembrolizumab 2 mg/kg Q3W (Part F), NSCLC: Pembrolizumab 5 mg/kg Q3W (Part E-Not Enrolled), Solid Tumors: Pembrolizumab 1 mg/kg Q2W (Part A), Solid Tumors: Pembrolizumab 10 mg/kg Q2W (Parts A+A1), Solid Tumors: Pembrolizumab 3 mg/kg Q2W (Part A), Solid Tumors: Pembrolizumab Titration Cohort 1 Q3W (Part A2), Solid Tumors: Pembrolizumab Titration Cohort 2 Q3W (Part A2), Solid Tumors: Pembrolizumab Titration Cohort 3 Q3W (Part A2)

Answer: D