Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
Brief Summary: This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.


Options:
A: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); Overall Survival (OS) - All Participants (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); OS - Participants With PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months)); OS - Participants With Strongly PD-L1 Positive Tumors (Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months))
B: Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC) (From the date of first dose up to approximately 2 years and 2 months)
C: Percentage of Participants With Adverse Events (AEs) (Baseline up to end of study (up to approximately 6 years))
D: Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase (For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase (From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)); Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase (From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)); Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase (From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)); Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase (From Baseline (Day 1) through 90 days after the last dose of study drug (approximately 5.25 years)); Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC Who Had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase (From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)); ORR Assessed by BICR in Participants With Squamous NSCLC Who Had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase (From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)); ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) Who Had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase (From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years))

Answer: D