Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Double-blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/or Metastatic Renal Cell Carcinoma
Brief Summary: To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Bevacizumab, Drug: Temsirolimus | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bevacizumab, Drug: Interferon-Alfa 9MU | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Temsirolimus; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Interferon-Alfa 9MU; Assigned to Arm(s): 2
B: Arm Label: Sunitinib; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sunitinib | Arm Label: IMA901 plus GM-CSF added to sunitinib after single dose of cy; Type: EXPERIMENTAL; Interventions: Drug: Sunitinib, Biological: GM-CSF, Drug: Cyclophosphamide, Drug: IMA901 | Intervention Type: DRUG; Name: Sunitinib; Assigned to Arm(s): IMA901 plus GM-CSF added to sunitinib after single dose of cy, Sunitinib | Intervention Type: BIOLOGICAL; Name: GM-CSF; Assigned to Arm(s): IMA901 plus GM-CSF added to sunitinib after single dose of cy | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): IMA901 plus GM-CSF added to sunitinib after single dose of cy | Intervention Type: DRUG; Name: IMA901; Assigned to Arm(s): IMA901 plus GM-CSF added to sunitinib after single dose of cy
C: Arm Label: Cohort A: MSI Positive Colorectal Cancer; Type: EXPERIMENTAL; Interventions: Drug: MK-3475 | Arm Label: Cohort B: MSI Negative Colorectal Cancer; Type: EXPERIMENTAL; Interventions: Drug: MK-3475 | Arm Label: Cohort C: MSI Positive Non-Colorectal Cancer; Type: EXPERIMENTAL; Interventions: Drug: MK-3475 | Intervention Type: DRUG; Name: MK-3475; Assigned to Arm(s): Cohort A: MSI Positive Colorectal Cancer, Cohort B: MSI Negative Colorectal Cancer, Cohort C: MSI Positive Non-Colorectal Cancer
D: Arm Label: placebo arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: pazopanib arm; Type: EXPERIMENTAL; Interventions: Drug: Pazopanib | Intervention Type: DRUG; Name: Pazopanib; Assigned to Arm(s): pazopanib arm | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo arm

Answer: D