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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03407144
Collaborator
(none)
340
91
2
106.2
3.7
0

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
340 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667)
Actual Study Start Date :
Apr 9, 2018
Anticipated Primary Completion Date :
Feb 13, 2027
Anticipated Study Completion Date :
Feb 13, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pembrolizumab + AVD (Group 1)

After receiving two 4-week cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) induction therapy, SER participants in Group 1 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) on Day 1 of each 3-week cycle (Q3W) in combination with two cycles of AVD chemotherapy (doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2 and dacarbazine 375 mg/m^2 on Days 1 and 15; cycle frequency every 4 weeks [Q4W]). All SERs in Group 1 will receive radiotherapy (RT) after completing AVD chemotherapy.

Biological: pembrolizumab
2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W
Other Names:
  • MK-3475
  • Drug: doxorubicin
    25 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 40 mg/m^2 IV on Days 1 and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 25 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)

    Drug: vinblastine
    6 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 6 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)

    Drug: dacarbazine
    375 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 375 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1) 250 mg/m^2 IV on Days 1 to 3 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

    Drug: bleomycin
    10 units/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1)

    Radiation: Radiotherapy (RT)
    RT administered daily, dose dependent on randomization group and disease response.

    Experimental: Pembrolizumab + COPDAC-28 (Group 2)

    After receiving two 4-week cycles of OEPA (vincristine, etoposide/etopophos, prednisone/prednisolone and doxorubicin) induction therapy, SER participants in Group 2 will receive pembrolizumab 2 mg/kg up to a maximum of 200 mg (3 to 17 years of age) or 200 mg (18 to 25 years of age) Q3W, in combination with 4 cycles of COPDAC-28 chemotherapy (cyclophosphamide 500 mg/m^2 on Days 1 and 8, vincristine 1.5 mg/m^2 with maximum single dose 2 mg on Days 1 and 8, prednisone/prednisolone 40 mg/m^2/day divided in 3 doses on Days 1 to 15, dacarbazine 250 mg/m^2 on Days 1 to 3; cycle frequency Q4W). SERs in Group 2 will receive RT if they have a positive Positron Emission Tomography (PET) response after completing COPDAC-28 chemotherapy.

    Biological: pembrolizumab
    2 mg/kg intravenous (IV) up to a max of 200 mg (3 to 17 years of age) or 200 mg IV (18 to 25 years of age); cycle frequency Q3W
    Other Names:
  • MK-3475
  • Drug: doxorubicin
    25 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 40 mg/m^2 IV on Days 1 and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 25 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1)

    Drug: dacarbazine
    375 mg/m^2 IV on Days 1 and 15 as part of ABVD induction therapy (cycle frequency: Q4W, Group 1) 375 mg/m^2 IV on Days 1 and 15 as part of AVD chemotherapy (cycle frequency: Q4W, Group 1) 250 mg/m^2 IV on Days 1 to 3 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

    Drug: cyclophosphamide
    500 mg/m^2 IV on days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

    Drug: vincristine
    1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1, 8, and 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 1.5 mg/m^2 IV with maximum single dose 2 mg on Days 1 and 8 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

    Drug: prednisone/prednisolone
    60 mg/m^2/day orally divided in 3 doses on Days 1 to 15 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2) 40 mg/m^2/day orally divided in 3 doses on Days 1 to 15 as part of COPDAC-28 chemotherapy (cycle frequency: Q4W, Group 2)

    Drug: etoposide
    125 mg/m^2 IV on Days 1 to 5 as part of OEPA induction therapy (cycle frequency: Q4W, Group 2)
    Other Names:
  • Etoposide Phosphate
  • Radiation: Radiotherapy (RT)
    RT administered daily, dose dependent on randomization group and disease response.

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as Assessed by Blinded Independent Central Review (BICR) [Up to approximately 8 years]

      ORR is defined as the percentage of SER participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) using IWG revised response criteria and determined by BICR. The ORR will be estimated by risk group in SER participants.

    Secondary Outcome Measures

    1. Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD or COPDAC-28 Chemotherapy [Up to approximately 8 years]

      The rate of PET negativity for SER participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of AVD (Group 1) or four cycles of COPDAC-28 (Group 2), in combination with pembrolizumab. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

    2. Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR [Up to approximately 8 years]

      EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by BICR using IWG criteria.

    3. Overall Survival (OS) in SER Participants By Risk Group (Low, High) [Up to approximately 8 years]

      OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.

    4. Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High) [Up to approximately 8 years]

      The frequency of RT received by eligible participants (positive PET response, i.e. Deauville score of 4 or 5) will be reported.

    5. Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy [Up to approximately 8 years]

      The rate of PET negativity for Group 1 participants is the percentage of participants with PET negativity (defined as Deauville score 1, 2 or 3) after two cycles of ABVD induction as per investigator assessment. The Deauville 5-point scoring system is an internationally accepted and utilized five-point scoring system for the FDG avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG PET scan: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately increased compared to the liver at any site, Score 5= Uptake markedly increased compared to the liver at any site or new lesions, Score X= New areas of uptake unlikely to be related to lymphoma. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

    6. EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator [Up to approximately 8 years]

      EFS is defined as the time from study enrollment to the first documented disease progression or recurrence, or death due to any cause, whichever occurs first. Progression/disease recurrence will be determined by the investigator.

    7. OS in RER Participants By Risk Group (Low, High) [Up to approximately 8 years]

      OS is defined as the time from study enrollment to death due to any cause. Participants without documented death will be censored at the date of the last follow-up.

    8. Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High) [Up to approximately 8 years]

      Serum TARC levels will be measured and evaluated as a potential biomarker in SER participants by risk group at screening, early, and late response assessments.

    9. Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High) [Up to approximately 8 years]

      An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who experience an AE will be reported for each arm.

    10. Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High) [Up to approximately 8 years]

      An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of SER participants who discontinue study treatment due to an AE will be reported for each arm.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama ( Site 0023) Birmingham Alabama United States 35233
    2 Phoenix Childrens Hospital ( Site 0034) Phoenix Arizona United States 85016
    3 Arkansas Children's Hospital ( Site 0046) Little Rock Arkansas United States 72202
    4 Kaiser - Orange County ( Site 0084) Anaheim California United States 92806
    5 Kaiser Permanente ( Site 0082) Downey California United States 90242
    6 Kaiser - Fontana ( Site 0083) Fontana California United States 92335
    7 MemorialCare Health System - Long Beach Medical Center-Cherese Mari Laulhere Children's Village ( Si Long Beach California United States 90806
    8 Kaiser Permanente Downey Medical Center ( Site 0024) Los Angeles California United States 90027
    9 Kaiser Permanente - Oakland ( Site 0047) Oakland California United States 94611
    10 Kaiser Permanente - Roseville ( Site 0080) Roseville California United States 95661
    11 Kaiser Permanente - Santa Clara ( Site 0079) Santa Clara California United States 95051
    12 Children's Hospital - Colorado ( Site 0028) Aurora Colorado United States 80045
    13 Connecticut Children's Medical Center ( Site 0045) Hartford Connecticut United States 06106
    14 Yale Cancer Center ( Site 0061) New Haven Connecticut United States 06510
    15 Children's National Medical Center ( Site 0090) Washington District of Columbia United States 20010
    16 University of Florida ( Site 0051) Gainesville Florida United States 32610
    17 Memorial Regional Hospital/Joe DiMaggio Children's Hospital ( Site 0048) Hollywood Florida United States 33021
    18 Arnold Palmer Hospital ( Site 0065) Orlando Florida United States 32806
    19 Children's Healthcare of Atlanta at Egleston ( Site 0033) Atlanta Georgia United States 30322
    20 University of Chicago ( Site 0066) Chicago Illinois United States 60637
    21 Riley Hospital for Children ( Site 0091) Indianapolis Indiana United States 46202
    22 University of Kentucky Markey Cancer Center ( Site 0057) Lexington Kentucky United States 40536-0293
    23 University of Louisville-Norton Children's Hospital ( Site 0059) Louisville Kentucky United States 40202
    24 Johns Hopkins University ( Site 0025) Baltimore Maryland United States 21287
    25 Children's Hospital of Michigan ( Site 0056) Detroit Michigan United States 48201
    26 Karmanos Cancer Institute ( Site 0002) Detroit Michigan United States 48201
    27 Children's Hospitals and Clinics of Minnesota ( Site 0036) Minneapolis Minnesota United States 55404
    28 St. Louis Children's Hospital ( Site 0038) Saint Louis Missouri United States 63110
    29 Alliance for Childhood Diseases ( Site 0064) Las Vegas Nevada United States 89135
    30 Hackensack University Medical Center ( Site 0026) Hackensack New Jersey United States 07601
    31 Rutgers Cancer Institute of New Jersey ( Site 0027) New Brunswick New Jersey United States 08901
    32 Roswell Park Cancer Institute ( Site 0040) Buffalo New York United States 14263
    33 Cohen Children's Medical Center of New York ( Site 0052) New Hyde Park New York United States 11040
    34 Columbia University/Herbert Irving Cancer Center ( Site 0063) New York New York United States 10032
    35 Memorial Sloan Kettering Cancer Center ( Site 0060) New York New York United States 10065
    36 Weill Cornell Medicine ( Site 0032) New York New York United States 10065
    37 UNC Lineberger Comprehensive Cancer ( Site 0044) Chapel Hill North Carolina United States 27514
    38 Cincinnati Children's Hospital Medical Center ( Site 0035) Cincinnati Ohio United States 45229
    39 Nationwide Children's Hospital ( Site 0037) Columbus Ohio United States 43205-2696
    40 St. Francis Hospital Cancer Center ( Site 0001) Greenville South Carolina United States 29607
    41 Vanderbilt University Medical Center-Ingram Cancer Center ( Site 0054) Nashville Tennessee United States 37232
    42 Dell Children's Medical Center Of Central Texas ( Site 0058) Austin Texas United States 78723
    43 Children's Medical Center ( Site 0030) Dallas Texas United States 75235
    44 Texas Children's Hospital ( Site 0042) Houston Texas United States 77030
    45 Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute ( Site San Antonio Texas United States 78229
    46 Inova Fairfax Hospital ( Site 0031) Falls Church Virginia United States 22042
    47 Seattle Childrens Hospital ( Site 0022) Seattle Washington United States 98105
    48 Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 0507) Curitiba Parana Brazil 81520-060
    49 Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0510) Natal Rio Grande Do Norte Brazil 59075-740
    50 Instituto de Oncologia Pediatrica - GRAACC - Unifesp ( Site 0500) Sao Paulo Brazil 04023-062
    51 Hospital Pablo Tobon Uribe-Hematology ( Site 0565) Medellin Antioquia Colombia 05034
    52 Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0529) Barranquilla Atlantico Colombia 080020
    53 Oncomedica S.A. ( Site 0527) Monteria Cordoba Colombia 230001
    54 Instituto Nacional De Cancerologia ( Site 0566) Bogotá Cundinamarca Colombia 111511
    55 Fakultni nemocnice v Motole ( Site 0356) Praha 5 Czechia 150 06
    56 CHU de Marseille Hopital de la Timone Enfants ( Site 0449) Marseille Bouches-du-Rhone France 13005
    57 CHU de Bordeaux. Hopital Pellegrin ( Site 0447) Bordeaux Gironde France 33000
    58 Institut d'Hematologie-Oncologie Pediatrique (IHOP) ( Site 0448) Lyon Rhone-Alpes France 69373
    59 Institut Gustave Roussy ( Site 0445) Villejuif Val-de-Marne France 94800
    60 Hopital d'Enfants Armand Trousseau ( Site 0443) Paris France 75012
    61 Hopital Universitaire Robert Debre ( Site 0446) Paris France 75019
    62 Klinikum der Universitaet Muenchen-Campus Innenstadt ( Site 0414) Muenchen Bayern Germany 80337
    63 Universitaetsklinikum Giessen und Marburg GmbH ( Site 0411) Giessen Hessen Germany 35392
    64 Universitaetsklinikum Essen ( Site 0415) Essen Nordrhein-Westfalen Germany 45147
    65 Universitätsklinikum Münster - Albert Schweitzer Campus-Pädiatrische Hämatologie und Onkologie ( Sit Münster Nordrhein-Westfalen Germany 48149
    66 Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0413) Berlin Germany 13353
    67 Athens Childrens Hospital Aglaia Kyriakou ( Site 0361) Athens Attiki Greece 115 27
    68 University of Athens - Aghia Sophia Childrens Hospital ( Site 0362) Athens Attiki Greece 115 27
    69 University General Hospital of Thessaloniki "AHEPA" ( Site 0363) Thessaloniki Kentriki Makedonia Greece 546 36
    70 Oncomedica ( Site 0545) Guatemala Guatemala 01010
    71 Unidad Nacional de Oncologia Pediatrica ( Site 0542) Guatemala Guatemala 01011
    72 Medi-K Cayala ( Site 0544) Guatemala Guatemala 01016
    73 Universita degli Studi di Roma La Sapienza ( Site 0403) Roma Abruzzo Italy 00161
    74 Centro di Riferimento Oncologico CRO ( Site 0404) Aviano Pordenone Italy 33081
    75 Azienda Ospedaliera Santobono - Pausilipon ( Site 0402) Napoli Italy 80123
    76 IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0400) Roma Italy 00165
    77 Ospedale Infantile Regina Margherita ( Site 0401) Torino Italy 10126
    78 Severance Hospital Yonsei University Health System ( Site 0221) Seoul Korea, Republic of 03722
    79 Samsung Medical Center ( Site 0222) Seoul Korea, Republic of 06351
    80 Hospital Infantil de Mexico Federico Gomez ( Site 0535) Mexico D.F. Distrito Federal Mexico 06720
    81 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0531) Monterrey Nuevo Leon Mexico 66460
    82 UMAE Hospital de Especialidades - CMN La Raza ( Site 0536) Azcapotzalco Mexico 02990
    83 Hematologica Alta Especialidad ( Site 0532) Huixquilucan Mexico 52787
    84 Prinses Maxima Centrum ( Site 0461) Utrecht Netherlands 3584 CS
    85 Wits Clinical Research ( Site 0323) Johannesburg Gauteng South Africa 2193
    86 Albert Alberts Stem Cell Transplant Centre ( Site 0324) Pretoria Gauteng South Africa 0044
    87 Wits Clinical Research ( Site 0321) Soweto Gauteng South Africa 2193
    88 Hospital Universitari Vall d Hebron ( Site 0432) Barcelona Spain 08035
    89 Hospital Infantil Universitario Nino Jesus ( Site 0433) Madrid Spain 28009
    90 Hospital Universitario La Paz ( Site 0434) Madrid Spain 28046
    91 University College London Hospitals NHS Foundation Trust ( Site 0454) London London, City Of United Kingdom NW1 2PG

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT03407144
    Other Study ID Numbers:
    • 3475-667
    • MK-3475-667
    • 2017-001123-53
    First Posted:
    Jan 23, 2018
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merck Sharp & Dohme LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2022