Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)

Conditions

• Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
• Ipilimumab — BIOLOGICAL
  Administered as an IV infusion every 6 weeks (Q6W)
• Placebo — OTHER
  Normal saline solution administered as an IV infusion Q6W

Study Details

The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo. With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.

Key Dates

Start date

Dec 14, 2017

Status verified

Sep 2023

Primary completion

Sep 1, 2020

Completion

Sep 7, 2022

Study Design

Enrollment

568 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab + Ipilimumab
  Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.
• Active Comparator: Pembrolizumab + Placebo
  Participants receive 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 32 months (through data cut-off date: 01 Sep 2020) ]

Locations (25)

Find similar trials in Phoenix, AZ

Related Studies

• Molecular Analysis of Thoracic Malignancies
  Enrolling By Invitation · Stanford University · Stanford, California
• KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
  PHASE1/PHASE2 · Recruiting · Merck Sharp & Dohme LLC · Gilbert, Arizona
• KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
  Recruiting · Merck Sharp & Dohme LLC · Gilbert, Arizona
• Development and Analysis of a Stool Bank for Cancer Patients
  Recruiting · Persephone Biosciences · Fountain Valley, California