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)

Summary

This study using pembrolizumab (MK-3475) will be done in 5 parts. In Part A, successive participant cohorts with advanced solid tumors will receive pembrolizumab to assess the safety and tolerability of monotherapy. In Parts B, C, and D, participants with advanced non-small cell lung cancer (NSCLC) will receive pembrolizumab in combination with either cisplatin/pemetrexed or carboplatin/pemetrexed (Part B); with either carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Part C); or with ipilimumab (Part D) by non-random assignment to assess the safety and tolerability of the combination therapy. In Part E, participants with untreated Extensive-disease (ED) Small Cell Lung Cancer (SCLC) will receive pembrolizumab in combination with either cisplatin/etoposide, carboplatin/etoposide, or cisplatin/etoposide with prophylactic use of granulocyte colony-stimulating factor (lasting G-CSF \[pegfilgrastim\]) by non-random assignment to assess the safety and tolerability of the combination therapy.

Conditions

• Solid Tumor
• Non-small Cell Lung Cancer
• Small 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-26

Primary Completion

2020-02-28

Completion

2020-02-28