A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT02039674
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
  • Paclitaxel — DRUG
    IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
  • Carboplatin — DRUG
    IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
  • Bevacizumab — BIOLOGICAL
    IV on Day 1 of each 3-week cycle
  • Pemetrexed — DRUG
    IV on Day 1 of each 3-week cycle
  • Ipilimumab — BIOLOGICAL
    IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
  • Erlotinib — DRUG
    Orally tablet once daily
  • Gefitinib — DRUG
    Oral tablet once daily

Study Details

The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC).

Key Dates

Start date
Feb 21, 2014
Status verified
Oct 2022
Primary completion
Nov 7, 2016
Completion
Oct 18, 2021

Study Design

Enrollment
267 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])
    Cohort A participants receive pembrolizumab (2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (Aare Under the Curve \[AUC\] 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])
    Cohort B2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)
    Cohort C2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])
    Cohort D1 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)
    Cohort E participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral tablet once a day on every day of each 3-week cycle.
  • Experimental: Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)
    Cohort F participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via oral tablet once a day on every day of each 3-week cycle.
  • Experimental: Part 2 Cohort G+ (Pembro 200mg+C+Pe)
    Cohort G+ participants receive pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 2 Cohort H (Pembro+I)
    Cohort H participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase II dose determined in Cohort D).
  • Experimental: Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])
    Cohort A10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \[mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])
    Cohort B10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)
    Cohort C10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 2 Cohort G- (Placebo+C+Pe)
    Cohort G- participants receive placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS.
  • Experimental: Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])
    Cohort D2 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.
  • Experimental: Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])
    Cohort D1 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.

Primary Outcome Measure

Part 2 Cohorts G+ and G-: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

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