A Multicenter, Open Label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

  • End date
    May 10, 2028
  • participants needed
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 21 October 2022
Toll Free Number
Primary Contact
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2801) (6.3 mi away) Contact
+388 other location
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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 roll-over 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 roll-over 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
Treatment Pembrolizumab, Standard of Care (SOC)
Clinical Study IdentifierNCT03486873
SponsorMerck Sharp & Dohme LLC
Last Modified on21 October 2022


Yes No Not Sure

Inclusion Criteria

Advanced unresectable or metastatic tumor(s)
Currently enrolled in a Merck-sponsored pembrolizumab study and is receiving study treatment or in a Follow-up Phase at the time MK-3475-587 is open. The parent studies must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into this MK-3475-587 extension study
Additional eligibility criteria for participants who enter Second Course Phase once they
are enrolled on MK-3475-587
Has not received any anticancer systemic treatment since the last dose of
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
pembrolizumab or a pembrolizumab-based combination in First Course Phase
Demonstrates adequate organ function
Have resolution of any toxic effect(s) of First Course Phase trial treatment with
pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except
alopecia) before trial treatment in Second Course Phase is started. If participant
received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered
from the toxicity and/or complications of the intervention
Male participant must agree to use contraception during the Second Course Phase study
treatment period and for ≥120 days, corresponding to time needed to eliminate any
study combination treatment(s), plus 75 days (a spermatogenesis cycle) for study
treatments with evidence of genotoxicity at any dose after the last dose of study
treatment and refrain from donating sperm during this period
A female participant is eligible to enroll if she is not pregnant, not breastfeeding
and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP)
who agrees to use contraception during the study treatment period and for ≥120 days
(corresponding to time needed to eliminate any study combination treatment(s) plus 30
days (a menstruation cycle) for study treatments with risk of genotoxicity

Exclusion Criteria

There are no exclusion criteria to participate in MK-3475-587
Has known active central nervous system metastases and/or carcinomatous meningitis
Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of or is positive for hepatitis B or hepatitis C
Participants are excluded from entering Second Course trial treatment once they are
enrolled on MK-3475-587 if any of the following criteria applies
Has hepatic decompensation (Child-Pugh score >6 [class B and C])
Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
Has uncontrolled thyroid dysfunction
Has received a live vaccine within 30 days prior to the first dose of Second Course
Has uncontrolled diabetes mellitus
Phase trial treatment
Has had an allogeneic tissue/solid organ transplant
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course
Has a known additional malignancy that is progressing or requires active treatment
Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with
curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the
skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast
cancer that has undergone potentially curative therapy
Has an active autoimmune disease that has required systemic treatment in the past 2
years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency) is not considered a form
of systemic treatment and is allowed
Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis. Note: Participants that experienced pneumonitis during First Course that
did not meet the criteria for permanent discontinuation are eligible
Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the Second Course Phase eligibility
Visit through 120 days after the last dose of study treatment
Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment
congestive heart failure (New York Heart Association Class III or IV) or symptomatic
ischemic heart disease
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