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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)

Trial Status: Active

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.

Inclusion Criteria

  • 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 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. - 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. 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 - 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)

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Rachel Feldman
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: APPROVED

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Maryland

Baltimore
MedStar Franklin Square Medical Center / Weinberg Cancer Institute
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: APPROVED

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: IN_REVIEW

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: systems coordinator
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Merck and Company Inc

  • Primary ID 3475-587
  • Secondary IDs NCI-2018-01717, MK-3475-587, 2017-004417-42, 195006, KEYNOTE-587, PHRR210209-002881
  • Clinicaltrials.gov ID NCT03486873