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RECRUITING

NCT03486873

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3500

Start Date

2018-08-21

Completion Date

2043-08-04

Last Updated

2026-10-29

Healthy Volunteers

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

Inclusion Criteria: * Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready. * Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies 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. Additional eligibility criteria for participants who enter dosing with Lenvatinib: * Adequately controlled blood pressure (BP) to \<150/90 mmHg, with or without antihypertensive medications. * For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib. * Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse. 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). Additional exclusion criteria for participants who enter dosing with Lenvatinib: * Has had major surgery within 3 weeks prior to first dose of study intervention(s). * Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula. * Has urine protein ≥1 g/24 hours. * Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO). * Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. * Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms. * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib. * Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug. * Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.

Locations (782)

Arizona Cancer Center at UMC North ( Site 0018)

Tucson, Arizona, United States

Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054)

Bakersfield, California, United States

California Cancer Associates for Research & Excellence ( Site 0016)

Fresno, California, United States

Providence Medical Foundation ( Site 0087)

Fullerton, California, United States

The Angeles Clinic and Research Institute ( Site 0005)

Los Angeles, California, United States

UCLA - Hematology/Oncology - Administrative Office ( Site 0009)

Los Angeles, California, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076)

Orange, California, United States

Stanford Cancer Center ( Site 0086)

Palo Alto, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004)

San Francisco, California, United States

Providence Saint John's Health Center ( Site 0059)

Santa Monica, California, United States

University of Colorado Cancer Center ( Site 0021)

Aurora, Colorado, United States

Yale Cancer Center ( Site 0014)

New Haven, Connecticut, United States

Georgetown University Medical Center ( Site 0023)

Washington D.C., District of Columbia, United States

Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022)

Fort Lauderdale, Florida, United States

Baptist MD Anderson Cancer Center ( Site 0083)

Jacksonville, Florida, United States

Mount Sinai Braman Comprehensive Cancer Center ( Site 0031)

Miami Beach, Florida, United States

Moffitt Cancer Center ( Site 0011)

Tampa, Florida, United States

Emory School of Medicine ( Site 0013)

Atlanta, Georgia, United States

Augusta University ( Site 0077)

Augusta, Georgia, United States

Northwest Georgia Oncology Centers PC ( Site 0061)

Marietta, Georgia, United States

Kaiser Permanente Moanalua Medical Center ( Site 0063)

Honolulu, Hawaii, United States

The University of Chicago ( Site 0020)

Chicago, Illinois, United States

University of Iowa Hospital and Clinics ( Site 0026)

Iowa City, Iowa, United States

James Graham Brown Cancer Center ( Site 0058)

Louisville, Kentucky, United States

Mercy Health-Paducah Cancer Center ( Site 0084)

Paducah, Kentucky, United States

Women's Cancer Care ( Site 0088)

Covington, Louisiana, United States

MedStar Franklin Square Medical Center ( Site 0046)

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056)

Baltimore, Maryland, United States

Maryland Oncology Hematology (MOH) ( Site 8000)

Columbia, Maryland, United States

Massachusetts General Hospital ( Site 0041)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute ( Site 0006)

Boston, Massachusetts, United States

Karmanos Cancer Institute ( Site 0047)

Detroit, Michigan, United States

Mayo Clinic in Rochester, Minnesota ( Site 0002)

Rochester, Minnesota, United States

Comprehensive Cancer Centers of Nevada ( Site 0043)

Las Vegas, Nevada, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038)

Hackensack, New Jersey, United States

Cancer Institute of New Jersey ( Site 0025)

New Brunswick, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032)

New York, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0012)

New York, New York, United States

White Plains Hospital-Center for Cancer Care ( Site 0069)

White Plains, New York, United States

WakeMed Cancer Care - Waverly Hematology & Medical Oncology ( Site 0074)

Cary, North Carolina, United States

University of North Carolina at Chapel Hill ( Site 0040)

Chapel Hill, North Carolina, United States

Levine Cancer Institute ( Site 0034)

Charlotte, North Carolina, United States

Duke Cancer Center ( Site 0028)

Durham, North Carolina, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0065)

Fargo, North Dakota, United States

University Hospitals ( Site 0044)

Cleveland, Ohio, United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0082)

Tulsa, Oklahoma, United States

Providence Portland Medical Center ( Site 0051)

Portland, Oregon, United States

St. Luke's University Health Network ( Site 0017)

Easton, Pennsylvania, United States

University of Pennsylvania ( Site 0010)

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center ( Site 0042)

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center ( Site 0008)

Pittsburgh, Pennsylvania, United States

Saint Francis Health System ( Site 0089)

Greenville, South Carolina, United States

Sanford Cancer Center ( Site 0066)

Sioux Falls, South Dakota, United States

West Cancer Center and Research Institute ( Site 0055)

Germantown, Tennessee, United States

Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060)

Nashville, Tennessee, United States

Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0015)

Nashville, Tennessee, United States

Texas Oncology - Central/South Texas ( Site 8001)

Austin, Texas, United States

Texas Oncology-Baylor Sammons Cancer Center ( Site 0062)

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center ( Site 0007)

Houston, Texas, United States

South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001)

San Antonio, Texas, United States

University of Virginia Health System ( Site 0035)

Charlottesville, Virginia, United States

Bon Secours St. Francis Medical Center-Oncology Research ( Site 0075)

Midlothian, Virginia, United States

VCU Health Adult Outpatient Pavillion ( Site 0080)

Richmond, Virginia, United States

Blue Ridge Cancer Care ( Site 0067)

Roanoke, Virginia, United States

Fred Hutchinson Cancer Center ( Site 0024)

Bellevue, Washington, United States

Centro de Oncología e Investigación de Buenos Aires ( Site 1357)

Berazategui, Buenos Aires, Argentina

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 1368)

Buenos Aires., Buenos Aires, Argentina

Fundacion Favaloro ( Site 1367)

CABA, Buenos Aires, Argentina

Derma Internacional SA ( Site 1372)

CABA, Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 1364)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

IDIM - Instituto de Investigaciones Metabólicas ( Site 1362)

Ciudad de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1363)

Mar del Plata, Buenos Aires, Argentina

Instituto Médico Río Cuarto ( Site 1375)

Río Cuarto, Córdoba Province, Argentina

Clinica Viedma ( Site 1353)

Viedma, Río Negro Province, Argentina

Fundacion Estudios Clinicos ( Site 1369)

Rosario, Santa Fe Province, Argentina

Sanatorio Parque ( Site 1355)

Rosario, Santa Fe Province, Argentina

Instituto de Oncologia de Rosario ( Site 1350)

Rosario, Santa Fe Province, Argentina

Hospital Provincial del Centenario ( Site 1359)

Rosario, Santa Fe Province, Argentina

Hospital Aleman-Oncology ( Site 1351)

Buenos Aires, Argentina

Clínica Universitaria Reina Fabiola ( Site 1376)

Córdoba, Argentina

Centro Medico Privado CEMAIC ( Site 1371)

Córdoba, Argentina

Hospital Privado Universitario de Córdoba ( Site 1354)

Córdoba, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1358)

La Rioja, Argentina

Instituto San Marcos ( Site 1366)

San Juan, Argentina

Centro Medico San Roque-Oncology ( Site 1352)

San Miguel de Tucumán, Argentina

Centro Oncologico Norte. ( Site 1370)

Santiago del Estero, Argentina

Chris OBrien Lifehouse ( Site 3003)

Camperdown, New South Wales, Australia

Royal Prince Alfred Hospital-A.W. Morrow Gastroenterology and Liver Centre ( Site 3016)

Camperdown, New South Wales, Australia

Liverpool Hospital-Medical Oncology ( Site 3021)

Liverpool, New South Wales, Australia

Macquarie University ( Site 3010)

Macquarie University, New South Wales, Australia

Mater Hospital Sydney ( Site 3007)

North Sydney, New South Wales, Australia

Orange Hospital-Clinical Trials Unit ( Site 3027)

Orange, New South Wales, Australia

Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3020)

Port Macquarie, New South Wales, Australia

Royal North Shore Hospital-Medical Oncology Clinical Trials ( Site 3025)

St Leonards, New South Wales, Australia

Calvary Mater Newcastle ( Site 3005)

Waratah, New South Wales, Australia

Westmead Hospital ( Site 3000)

Westmead, New South Wales, Australia

Melanoma Institute Australia ( Site 3001)

Wollstonecraft, New South Wales, Australia

Mater Misericordiae Limited-Medical Oncology ( Site 3019)

Brisbane, Queensland, Australia

Gallipoli Medical Research Ltd ( Site 3011)

Brisbane, Queensland, Australia

Royal Brisbane and Women's Hospital ( Site 3009)

Herston, Queensland, Australia

And 682 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (782)