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Protocol # 18-418

Status

Recruiting

Description

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 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 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 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.

Condition

  • Solid Tumors
  • Hematologic Malignancies

Interventions

  • Pembrolizumab
  • Standard of Care (SOC)

Phase

Phase 3

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall Survival (OS)

Secondary Outcome:

  • Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study
  • Duration of Complete Response (DOCR) Per Evaluation Criteria Used in the Parent Study
  • Number of Participants Who Experience Serious Adverse Events (SAEs)
  • Number of Participants Who Experience Adverse Events of Special Interest (AEOSI)
  • Number of Participants Who Experience Events of Clinical Interest (ECI)
  • Number of Participants Who Discontinue Study Treatment Due to an AE

Enrollment

2300

Study Start Date

August 21, 2018

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Merck Sharp & Dohme LLC

Source

Merck Sharp & Dohme LLC

Official title

A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab

Clinicaltrials.gov Identifier

NCT03486873

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.