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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)

Cancer Type
Unknown Primary
Trial Phase
Phase III
18 Years and older, Male and Female
Study Type
Protocol IDs
3475-587 (primary)
Study Sponsor
Merck Sharp & Dohme LLC


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.


  1. Inclusion Criteria: - Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready - Currently receiving pembrolizumab or in a follow-up phase 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 pembrolizumab or a pembrolizumab-based combination in First Course Phase - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - 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. - 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. 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 severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients - Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment - 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 immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase - 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 known active central nervous system metastases and/or carcinomatous meningitis - 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. - 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. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis. - 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. - Has hepatic decompensation (Child-Pugh score >6 [class B and C]) - Has uncontrolled thyroid dysfunction - Has uncontrolled diabetes mellitus - Has had an allogeneic tissue/solid organ transplant - Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

Treatment Sites in Georgia

Emory University School of Medicine

1440 Clifton Road
Atlanta, GA 30322

Northwest Georgia Oncology Centers - Austell

1700 Hospital South Drive
Suite 300
Austell, GA 30106


Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen

200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110


Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton

157 Clinic Avenue
Suite 101
Carrollton, GA 30117


Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville

100 Market Place Boulevard
Suite 200
Cartersville, GA 30121


Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville

6002 Professional Parkway
Suite 220
Douglasville, GA 30134


Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper

1020 J.L. White Drive
Suite 160
Jasper, GA 30143


Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta

340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060

Northwest Georgia Oncology Centers - Paulding

144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141


Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica

705 Dallas Highway
Suite 204
Villa Rica, GA 30180


Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

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