Non Hodgkin Lymphoma Clinical Trial

Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)

Summary

This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs) to frontline chemotherapy.

View Full Description

Full Description

Group 1 will consist of low-risk participants with cHL Stages IA, IB and IIA without bulky disease. Group 2 will consist of high-risk participants with cHL Stages IIEB, IIIEA, IIIEB, IIIB, IVA and IVB.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Group 1: Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma (cHL) at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB
Has measurable disease per investigator assessment
Male participants are eligible to participate if they agree to the following during the intervention period: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic
Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
Performance status: Lansky Play-Performance Scale ≥50 for children up to 16 years of age OR Karnofsky score ≥50 for participants ≥ 16 years of age
Has adequate organ function

Exclusion Criteria:

Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years
WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment
Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%
Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a MSD pembrolizumab (MK-3475) clinical study
Has received any prior systemic anti-cancer therapy,including investigational agents for current diagnosis before randomization
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
Has a known additional malignancy that is progressing or requires active treatment within the past 3 years
Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis
Has severe hypersensitivity (≥Grade 3) to any study therapies including any excipients
An active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/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 Hepatitis B or known active Hepatitis C virus infection
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

340

Study ID:

NCT03407144

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 87 Locations for this study

See Locations Near You

Children's Hospital of Alabama ( Site 0023)
Birmingham Alabama, 35233, United States More Info
Study Coordinator
Contact
205-638-5430
Phoenix Childrens Hospital ( Site 0034)
Phoenix Arizona, 85016, United States More Info
Study Coordinator
Contact
602-933-4649
Arkansas Children's Hospital ( Site 0046)
Little Rock Arkansas, 72202, United States More Info
Study Coordinator
Contact
501-364-1494
Kaiser - Orange County ( Site 0084)
Anaheim California, 92806, United States More Info
Study Coordinator
Contact
323-783-8831
Kaiser Permanente ( Site 0082)
Downey California, 90242, United States More Info
Study Coordinator
Contact
323-783-8831
Kaiser - Fontana ( Site 0083)
Fontana California, 92335, United States More Info
Study Coordinator
Contact
323-783-8831
MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si
Long Beach California, 90806, United States
Kaiser Permanente Downey Medical Center ( Site 0024)
Los Angeles California, 90027, United States More Info
Study Coordinator
Contact
323-783-5307
Kaiser Permanente - Oakland ( Site 0047)
Oakland California, 94611, United States More Info
Study Coordinator
Contact
510-752-6592
Kaiser Permanente - Roseville ( Site 0080)
Roseville California, 95661, United States More Info
Study Coordinator
Contact
510-752-6592
Kaiser Permanente - Santa Clara ( Site 0079)
Santa Clara California, 95051, United States
Children's Hospital - Colorado ( Site 0028)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
720-777-8855
Connecticut Children's Medical Center ( Site 0045)
Hartford Connecticut, 06106, United States
Yale Cancer Center ( Site 0061)
New Haven Connecticut, 06510, United States More Info
Study Coordinator
Contact
203-785-7640
Children's National Medical Center ( Site 0090)
Washington District of Columbia, 20010, United States More Info
Study Coordinator
Contact
202-476-2800
University of Florida ( Site 0051)
Gainesville Florida, 32610, United States More Info
Study Coordinator
Contact
352-273-9120
Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048)
Hollywood Florida, 33021, United States
Arnold Palmer Hospital ( Site 0065)
Orlando Florida, 32806, United States More Info
Study Coordinator
Contact
321-841-2008
Children's Healthcare of Atlanta at Egleston ( Site 0033)
Atlanta Georgia, 30322, United States More Info
Study Coordinator
Contact
404-785-2025
University of Chicago ( Site 0066)
Chicago Illinois, 60637, United States More Info
Study Coordinator
Contact
773-702-6808
Riley Hospital for Children ( Site 0091)
Indianapolis Indiana, 46202, United States More Info
Study Coordinator
Contact
317-944-8784
University of Kentucky Markey Cancer Center ( Site 0057)
Lexington Kentucky, 40536, United States More Info
Study Coordinator
Contact
859-323-6975
University of Louisville-Norton Children's Hospital ( Site 0059)
Louisville Kentucky, 40202, United States More Info
Study Coordinator
Contact
502-588-3600
Johns Hopkins University ( Site 0025)
Baltimore Maryland, 21287, United States More Info
Study Coordinator
Contact
410-502-9302
Children's Hospital of Michigan ( Site 0056)
Detroit Michigan, 48201, United States More Info
Study Coordinator
Contact
313-966-8541
Karmanos Cancer Institute ( Site 0002)
Detroit Michigan, 48201, United States More Info
Study Coordinator
Contact
313-576-8673
Children's Hospitals and Clinics of Minnesota ( Site 0036)
Minneapolis Minnesota, 55404, United States More Info
Study Coordinator
Contact
612-813-5940
St. Louis Children's Hospital ( Site 0038)
Saint Louis Missouri, 63110, United States More Info
Study Coordinator
Contact
314-454-6018
Alliance for Childhood Diseases ( Site 0064)
Las Vegas Nevada, 89135, United States
Hackensack University Medical Center ( Site 0026)
Hackensack New Jersey, 07601, United States More Info
Study Coordinator
Contact
551-996-3457
Rutgers Cancer Institute of New Jersey ( Site 0027)
New Brunswick New Jersey, 08901, United States More Info
Study Coordinator
Contact
732-235-6363
Roswell Park Cancer Institute ( Site 0040)
Buffalo New York, 14263, United States More Info
Study Coordinator
Contact
716-845-1084
Cohen Children's Medical Center of New York ( Site 0052)
New Hyde Park New York, 11040, United States More Info
Study Coordinator
Contact
718-470-3460
Columbia University/Herbert Irving Cancer Center ( Site 0063)
New York New York, 10032, United States More Info
Study Coordinator
Contact
212-305-5808
Memorial Sloan Kettering Cancer Center ( Site 0060)
New York New York, 10065, United States More Info
Study Coordinator
Contact
212-639-5226
Weill Cornell Medicine ( Site 0032)
New York New York, 10065, United States More Info
Study Coordinator
Contact
646-962-9317
UNC Lineberger Comprehensive Cancer ( Site 0044)
Chapel Hill North Carolina, 27514, United States More Info
Study Coordinator
Contact
919-966-0985
Cincinnati Children's Hospital Medical Center ( Site 0035)
Cincinnati Ohio, 45229, United States More Info
Study Coordinator
Contact
513-636-2047
Nationwide Children's Hospital ( Site 0037)
Columbus Ohio, 43205, United States More Info
Study Coordinator
Contact
614-722-3562
St. Francis Hospital Cancer Center ( Site 0001)
Greenville South Carolina, 29607, United States More Info
Study Coordinator
Contact
864-603-6213
Vanderbilt University Medical Center-Ingram Cancer Center ( Site 0054)
Nashville Tennessee, 37232, United States More Info
Study Coordinator
Contact
615-936-1762
Dell Children's Medical Center Of Central Texas ( Site 0058)
Austin Texas, 78723, United States More Info
Study Coordinator
Contact
512-628-1902
Children's Medical Center ( Site 0030)
Dallas Texas, 75235, United States More Info
Study Coordinator
Contact
214-456-2382
Texas Children's Hospital ( Site 0042)
Houston Texas, 77030, United States More Info
Study Coordinator
Contact
832-822-4242
Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute ( Site
San Antonio Texas, 78229, United States More Info
Study Coordinator
Contact
210-575-6240
Inova Fairfax Hospital ( Site 0031)
Falls Church Virginia, 22042, United States More Info
Study Coordinator
Contact
703-531-3627
Seattle Childrens Hospital ( Site 0022)
Seattle Washington, 98105, United States More Info
Study Coordinator
Contact
206-987-2106
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 0507)
Curitiba Parana, 81520, Brazil More Info
Study Coordinator
Contact
+554133615195
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0510)
Natal Rio Grande Do Norte, 59075, Brazil More Info
Study Coordinator
Contact
+558440095595
Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0500)
Sao Paulo , 04023, Brazil More Info
Study Coordinator
Contact
+551150808489
Hospital Pablo Tobon Uribe-Hematology ( Site 0565)
Medellin Antioquia, 05034, Colombia More Info
Study Coordinator
Contact
+576044459753
Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529)
Barranquilla Atlantico, 08002, Colombia
Oncomedica S.A. ( Site 0527)
Monteria Cordoba, 23000, Colombia More Info
Study Coordinator
Contact
+573135124311
Instituto Nacional De Cancerologia ( Site 0566)
Bogotá Distrito Capital De Bogota, 11151, Colombia More Info
Study Coordinator
Contact
+576013905012 Ext.5400-5403
Fakultni nemocnice v Motole ( Site 0356)
Praha 5 , 150 0, Czechia More Info
Study Coordinator
Contact
+420224436457
CHU de Marseille Hopital de la Timone Enfants ( Site 0449)
Marseille Bouches-du-Rhone, 13005, France More Info
Study Coordinator
Contact
+33491386779
CHU de Bordeaux. Hopital Pellegrin ( Site 0447)
Bordeaux Gironde, 33000, France More Info
Study Coordinator
Contact
+33557820438
Institut d'Hematologie-Oncologie Pediatrique (IHOP) ( Site 0448)
Lyon Rhone-Alpes, 69373, France More Info
Study Coordinator
Contact
+33478782642
Institut Gustave Roussy ( Site 0445)
Villejuif Val-de-Marne, 94800, France More Info
Study Coordinator
Contact
+33142116541
Hopital d'Enfants Armand Trousseau ( Site 0443)
Paris , 75012, France More Info
Study Coordinator
Contact
+33144736062
Hopital Universitaire Robert Debre ( Site 0446)
Paris , 75019, France More Info
Study Coordinator
Contact
+33140034740
Klinikum der Universitaet Muenchen-Campus Innenstadt ( Site 0414)
Muenchen Bayern, 80337, Germany More Info
Study Coordinator
Contact
+4989440052759
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411)
Giessen Hessen, 35392, Germany More Info
Study Coordinator
Contact
+4964198559524
Universitaetsklinikum Essen ( Site 0415)
Essen Nordrhein-Westfalen, 45147, Germany More Info
Study Coordinator
Contact
+492017233784
Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Sit
Münster Nordrhein-Westfalen, 48149, Germany More Info
Study Coordinator
Contact
+492518347742
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0413)
Berlin , 13353, Germany More Info
Study Coordinator
Contact
+4930450666897
Athens Childrens Hospital Aglaia Kyriakou ( Site 0361)
Athens Attiki, 115 2, Greece More Info
Study Coordinator
Contact
+306973973179
University of Athens - Aghia Sophia Childrens Hospital ( Site 0362)
Athens Attiki, 115 2, Greece More Info
Study Coordinator
Contact
+306945709592
University General Hospital of Thessaloniki "AHEPA" ( Site 0363)
Thessaloniki Kentriki Makedonia, 546 3, Greece More Info
Study Coordinator
Contact
+306944944777
Oncomedica ( Site 0545)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
+50222781269
Unidad Nacional de Oncologia Pediatrica ( Site 0542)
Guatemala , 01011, Guatemala More Info
Study Coordinator
Contact
+50259010669
Medi-K Cayala ( Site 0544)
Guatemala , 01016, Guatemala
Universita degli Studi di Roma La Sapienza ( Site 0403)
Roma Abruzzo, 00161, Italy More Info
Study Coordinator
Contact
+390649974753
Centro di Riferimento Oncologico CRO ( Site 0404)
Aviano Pordenone, 33081, Italy
Azienda Ospedaliera Santobono - Pausilipon ( Site 0402)
Napoli , 80123, Italy More Info
Study Coordinator
Contact
+390812205404
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400)
Roma , 00165, Italy More Info
Study Coordinator
Contact
+390668592129
Ospedale Infantile Regina Margherita ( Site 0401)
Torino , 10126, Italy More Info
Study Coordinator
Contact
+390113135230
Severance Hospital Yonsei University Health System ( Site 0221)
Seoul , 03722, Korea, Republic of
Samsung Medical Center ( Site 0222)
Seoul , 06351, Korea, Republic of
Hospital Infantil de Mexico Federico Gomez ( Site 0535)
Mexico D.F. Distrito Federal, 06720, Mexico More Info
Study Coordinator
Contact
+525552289917
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0531)
Monterrey Nuevo Leon, 64460, Mexico More Info
Study Coordinator
Contact
+528183486136
UMAE Hospital de Especialidades - CMN La Raza ( Site 0536)
Azcapotzalco , 02990, Mexico More Info
Study Coordinator
Contact
+525557245900
Hematologica Alta Especialidad ( Site 0532)
Huixquilucan , 52787, Mexico More Info
Study Coordinator
Contact
+5215521291399
Prinses Maxima Centrum ( Site 0461)
Utrecht , 3584 , Netherlands More Info
Study Coordinator
Contact
+31889727272
Wits Clinical Research ( Site 0323)
Johannesburg Gauteng, 2193, South Africa More Info
Study Coordinator
Contact
+27113390600
Albert Alberts Stem Cell Transplant Centre ( Site 0324)
Pretoria Gauteng, 0044, South Africa More Info
Study Coordinator
Contact
+27129932555
Wits Clinical Research ( Site 0321)
Soweto Gauteng, 2193, South Africa More Info
Study Coordinator
Contact
+27119339589
Hospital Universitari Vall d Hebron ( Site 0432)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34934894398
Hospital Infantil Universitario Nino Jesus ( Site 0433)
Madrid , 28009, Spain More Info
Study Coordinator
Contact
+34915035900812
Hospital Universitario La Paz ( Site 0434)
Madrid , 28046, Spain More Info
Study Coordinator
Contact
+34917277223
University College London Hospitals NHS Foundation Trust ( Site 0454)
London London, City Of, NW1 2, United Kingdom More Info
Study Coordinator
Contact
+442034567890

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

340

Study ID:

NCT03407144

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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