Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011)

PHASE1CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

April 26, 2013

Primary Completion Date

February 28, 2020

Study Completion Date

February 28, 2020

Conditions
Solid TumorNon-small Cell Lung CancerSmall Cell Lung Cancer
Interventions
BIOLOGICAL

Pembrolizumab 2 mg/kg

Administered as an intravenous (IV) infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)

BIOLOGICAL

Pembrolizumab 10 mg/kg

Administered as an IV infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)

BIOLOGICAL

Pembrolizumab 200 mg

Administered as an IV infusion on Day 1 of each 21-day cycle

DRUG

Cisplatin 75 mg/m^2

Administered as an IV infusion on Day 1 of each 21-day cycle

DRUG

Pemetrexed 500 mg/m^2

Administered as an IV infusion on Day 1 of each 21-day cycle

DRUG

Carboplatin AUC 5 mg/mL/min

Administered as an IV infusion on Day 1 of each 21-day cycle

DRUG

Carboplatin AUC 6 mg/mL/min

Administered as an IV infusion on Day 1 of each 21-day cycle

DRUG

Paclitaxel 200 mg/m^2

Administered as an IV infusion on Day 1 of each 21-day cycle

DRUG

Nab-paclitaxel 100 mg/m^2

Administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle

BIOLOGICAL

Ipilimumab 1 mg/kg

Administered as an IV infusion on Day 1 of every other 21-day cycle (every 42 days)

DRUG

Etoposide 100 mg/m^2

Administered as an IV infusion on Days 1, 2, and 3 of each 21-day cycle

DRUG

G-CSF (pegfilgrastim) 3.6 mg

Administered as a subcutaneous injection on Day 4 of Cycle 1

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01840579 - Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011) | Biotech Hunter | Biotech Hunter