Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.

This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.

Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

Conditions

• Solid Tumors
• Hematologic Malignancies

Interventions

DRUG

Pembrolizumab

200 or 400 mg IV infusion

DRUG

Standard of Care (SOC)

IV infusion or oral tablets

DRUG

Lenvatinib

Oral capsules

DRUG

Olaparib

300mg or 250mg or 100mg oral tablers

DRUG

MK-4280

IV Infusion

BIOLOGICAL

MK-4280A

800mg favezelimab + 200mg pembrolizumab IV Infusion

BIOLOGICAL

Pembrolizumab (+) Berahyaluronidase alfa

395 mg or 790 mg SC administration

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

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-21

Primary Completion

2043-08-04

Completion

2043-08-04

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• Chile
• China
• Colombia
• Costa Rica
• Czechia
• Denmark
• Estonia
• Finland
• France
• Germany
• Greece
• Guatemala
• Hong Kong
• Hungary
• Ireland
• Israel
• Italy
• Japan
• Latvia
• Lithuania
• Malaysia
• Mexico
• Netherlands
• New Zealand
• Norway
• Peru
• Philippines
• Poland
• Portugal
• Puerto Rico
• Romania
• Russia
• Singapore
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine
• United Kingdom
• Vietnam

Study Locations