Clinical trial • Phase III • Oncology

PEMBROLIZUMAB for Non-small cell lung cancer

Phase III trial of PEMBROLIZUMAB for Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
28-02-2024
First CTIS Authorization Date
10-06-2024

Trial design

Randomised, pembrolizumab plus placebo (placebo to mk-1084) — pembrolizumab (keytruda 25 mg/ml concentrate for solution for infusion) with oral placebo to mk-1084 (comparator arm: pembrolizumab + placebo).-controlled Phase III trial in Italy, Bulgaria, Germany and others.

Randomised
Yes
Comparator
Pembrolizumab plus placebo (placebo to MK-1084) — pembrolizumab (KEYTRUDA 25 mg/mL concentrate for solution for infusion) with oral placebo to MK-1084 (comparator arm: pembrolizumab + placebo).
Biomarker Stratified
True, KRAS G12C mutation status and PD-L1 TPS ≥50%
Target Sample Size
445
Trial Duration For Participant
1095

Eligibility

Recruits 445 No vulnerable population selected (isVulnerablePopulationSelected: false). Standard informed consent process for adult participants is documented (site-specific L1_ICF main consent and optional consent/addenda documents are provided for participating countries)..

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). Standard informed consent process for adult participants is documented (site-specific L1_ICF main consent and optional consent/addenda documents are provided for participating countries).

Inclusion criteria

  • {"criterion_text":"- Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)\n- Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8\n- Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research\n- If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to < Grade 1 or baseline\n- If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)\n- If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n- If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable"}

Exclusion criteria

  • {"criterion_text":"- Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible.\n- Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC\n- Known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Has active autoimmune disease that has required systemic treatment in the past 2 years\n- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n- Is HIV-infected and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- Has history of allogenic tissue/solid organ transplant\n- Has not fully recovered from any effects of major surgical procedure\n- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease\n- Has known history of, or active, neurologic paraneoplastic syndrome\n- Has an active infection requiring systemic therapy, with exceptions\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n- Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease\n- Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC\n- Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention\n- Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1.\tProgression-free survival (PFS)","definition_or_measurement_approach":"PFS assessed according to RECIST 1.1 by Blinded Independent Central Review (BICR) (as specified in main objectives)"}
  • {"endpoint_text":"- 2.\tOverall survival (OS)","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomisation to death from any cause"}

Secondary endpoints

  • {"endpoint_text":"- 1.\tObjective response rate (ORR)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- 2.\tDuration of response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by BICR"}
  • {"endpoint_text":"- 3.\tNumber of participants who experience one or more Adverse Events (AEs)","definition_or_measurement_approach":"Safety reporting of AEs (count of participants with ≥1 AE)"}
  • {"endpoint_text":"- 4.\tNumber of participants who discontinue study treatment due to an AE","definition_or_measurement_approach":"Count of participants discontinuing treatment for AE"}
  • {"endpoint_text":"- 5.\tChange from baseline in global health status/quality of life (items 29 and 30) score, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)","definition_or_measurement_approach":"Change from baseline on EORTC QLQ-C30 global health status/QoL (items 29-30)"}
  • {"endpoint_text":"- 6.\tChange from baseline in the physical functioning (items 1-5) score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline on EORTC QLQ-C30 physical functioning (items 1-5)"}
  • {"endpoint_text":"- 7.\tChange from baseline in the role functioning (items 6-7) score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline on EORTC QLQ-C30 role functioning (items 6-7)"}
  • {"endpoint_text":"- 8.\tChange from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30","definition_or_measurement_approach":"Change from baseline on EORTC QLQ-C30 dyspnea (item 8)"}
  • {"endpoint_text":"- 9.\tChange from baseline in the cough (item 31) score, on the EORTC QLQ- LC13","definition_or_measurement_approach":"Change from baseline on EORTC QLQ-LC13 cough score (item 31)"}
  • {"endpoint_text":"- 10.\tChange from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13","definition_or_measurement_approach":"Change from baseline on EORTC QLQ-LC13 chest pain score (item 40)"}
  • {"endpoint_text":"- 11.\tTime to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30","definition_or_measurement_approach":"TTD based on EORTC QLQ-C30 global health status/QoL (items 29-30)"}
  • {"endpoint_text":"- 12.\tTTD in the physical functioning (items 1-5) score, on the EORTC-QLQ-C30","definition_or_measurement_approach":"TTD based on EORTC QLQ-C30 physical functioning (items 1-5)"}
  • {"endpoint_text":"- 13.\tTTD in the role functioning (items 6-7) score, on the EORTC QLQ-C30","definition_or_measurement_approach":"TTD based on EORTC QLQ-C30 role functioning (items 6-7)"}
  • {"endpoint_text":"- 14.\tTTD in the dyspnea (item 8) score, on the EORTC QLQ-C30","definition_or_measurement_approach":"TTD based on EORTC QLQ-C30 dyspnea (item 8)"}
  • {"endpoint_text":"- 15.\tTTD in the cough (item 31) score, on the EORTC QLQ-Lung Cancer version (LC13)","definition_or_measurement_approach":"TTD based on EORTC QLQ-LC13 cough (item 31)"}
  • {"endpoint_text":"- 16.\tTTD in the chest pain (item 40) score, on the EORTC QLQ-LC13","definition_or_measurement_approach":"TTD based on EORTC QLQ-LC13 chest pain (item 40)"}

Recruitment

Planned Sample Size
445
Recruitment Window Months
81
Consent Approach
Informed consent obtained from adult participants. Site-specific L1_ICF main consent forms and optional/ addendum consent documents are provided (multiple country/language versions listed in the application documents). Optional limited screening consents and addenda for disease progression and participant services are available. No assent for minors (no paediatric population selected).

Geography

Total Number Of Sites
61
Total Number Of Participants
194

Italy

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
394
Number Of Sites
10
Number Of Participants
34

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Oncologia clinica sperimentale Toraco-Polmonare
Contact Person Name
Alessandro Morabito
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOSD Sperimentazioni Cliniche: fase 1 e Medicina di Precisione
Contact Person Name
Gabriele Minuti
Contact Person Email
gabriele.minuti@ifo.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica Livorno
Contact Person Name
Giacomo Allegrini
Site Name
Istituto Nazionale Dei Tumori
Department Name
SC Oncologia Medica 1
Contact Person Name
Giuseppe Lo Russo
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia 2
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncologia Medica e dei tumori immuno-correlati
Contact Person Name
Brigida Stanzione
Contact Person Email
brigida.stanzione@cro.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Oncologia Toracica
Contact Person Name
Antonio Passaro
Contact Person Email
antonio.passaro@ieo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia Medica
Contact Person Name
Emilio Bria
Site Name
Azienda Ospedaliera Dei Colli
Department Name
UOSD DH Pneumologico e Pneumoncologico
Contact Person Name
Fabiana Vitiello
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncology Unit
Contact Person Name
Chiara Bennati
Contact Person Email
chiara.bennati@auslromagna.it

Bulgaria

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
94
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name
Department of medical oncology
Contact Person Name
Rossitsa Ruseva
Contact Person Email
uni@unihospitalbg.bg
Site Name
MBAL Serdika Ltd.
Department Name
Second department of medical oncology
Contact Person Name
Krassimir Koynov
Contact Person Email
infoct@mbalserdika.com
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
Clinic of Medical Oncology
Contact Person Name
Nataliya Chilingirova
Contact Person Email
info@cardiacinstitute.bg
Site Name
Medical Centre Futuremeds EOOD
Contact Person Name
Nikolay Shopov
Contact Person Email
info@futuremeds.bg
Site Name
Complex Oncological Center Plovdiv EOOD
Department Name
Base II, Department of medical oncology and oncology diseases in pneumology
Contact Person Name
Ivan Tonev
Contact Person Email
kocplovdiv@onkoplov.com

Germany

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
20
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Klinik für Innere Medizin, Hämatologie/ Onkologie
Contact Person Name
Florian Weissinger
Contact Person Email
florian.weissinger@evkb.de
Site Name
Krankenhaus Bethanien gGmbH
Department Name
Institut für Pneumologie an der Universität zu Köln
Contact Person Name
Lars Hagmeyer
Contact Person Email
institut@klinik-bethanien.de
Site Name
Vinzenz Von Paul Kliniken gGmbH
Department Name
Zentrum für Innere Medizin II
Contact Person Name
Christian-Friedrich Jehn
Contact Person Email
studienzentrum@vinzenz.de

France

Earliest CTIS Part Ii Submission Date
31-05-2024
Latest Decision Or Authorization Date
11-06-2024
Processing Time Days
11
Number Of Sites
8
Number Of Participants
26

Sites

Site Name
Centre Hospitalier Intercommunal De Cornouaille
Department Name
Pneumologie Oncologie
Contact Person Name
Romain Corre
Contact Person Email
romain.corre@ch-cornouaille.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pneumology, Thoracic Oncology & intensive respiratory care
Contact Person Name
Jacques Boutros
Contact Person Email
boutros.j@chu-nice.fr
Site Name
Centre Jean Perrin
Department Name
Oncologie thoracique et sarcome
Contact Person Name
Pascale Dubray-Longeras
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Centre Hospitalier Universitaire de Nîmes Institut de Cancérologie du Gard
Contact Person Name
Sylvie Van Hulst
Contact Person Email
sylvie.vanhulst@chu-nimes.fr
Site Name
Assoc Hospitaliere Nord Artois Clinique
Department Name
Oncologie thoracique
Contact Person Name
Géraldine Lauridant
Contact Person Email
glauridant@ahnac.com
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service d'oncologie thoracique
Contact Person Name
Ayoube Zouak
Contact Person Email
ayoube.zouak@chu-dijon.fr
Site Name
Hopital Ambroise Pare
Department Name
Maladies respiratoires et Oncologie thoracique
Contact Person Name
Etienne Giroux-Leprieur
Site Name
Centre Hospitalier D Avignon
Department Name
Hématologie clinique et oncologie médicale
Contact Person Name
Nicolas Cloarec
Contact Person Email
cloarec.nicolas@ch-avignon.fr

Spain

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
24
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Hospital Universitario De La Princesa
Department Name
Medical Oncology
Contact Person Name
Jacobo Rogado Revuelta
Contact Person Email
jacobo.rogado@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
David Vicente Baz
Contact Person Email
david.vbaz@gmail.com
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Contact Person Name
Delvys Rodriguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Vanesa Gutiérrez Calderon
Contact Person Email
vanesa_gutierrez78@hotmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology & Hematology
Contact Person Name
Manuel Dominé Gómez
Contact Person Email
lungtrialsfjd@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Medical Oncology
Contact Person Name
Jose Benitez Montañez
Contact Person Email
fasestempranas@ibima.eu

Romania

Earliest CTIS Part Ii Submission Date
15-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
33
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Centrul De Diagnostic Si Tratament Provita S.A.
Department Name
Oncology
Contact Person Name
Mircea Dediu
Contact Person Email
office@nord.ro
Site Name
Sigmedical Services S.R.L.
Department Name
Medical Oncology
Contact Person Name
Doina Ganea
Contact Person Email
motan_doina@yahoo.com
Site Name
Oncomed S.R.L.
Department Name
Medical Oncology
Contact Person Name
Daniela Sirbu
Contact Person Email
cabinet_oncomed@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Medical Oncology
Contact Person Name
Tudor Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Onco Card S.R.L.
Department Name
Medical Oncology
Contact Person Name
Bogdan Carlan
Contact Person Email
office@oncocard.ro

Greece

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
12-06-2024
Processing Time Days
89
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Clinic of Aristotle University of Thessaloniki
Contact Person Name
Dionisios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
Saint Savvas Oncology Hospital
Department Name
Β΄ Medical - Oncology Department
Contact Person Name
Anastasios Grivas
Contact Person Email
tssgrvs@gmail.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Vasileios Ramfidis
Contact Person Email
ramfidis@gmail.com
Site Name
St. Luke's Hospital S.A.
Department Name
Oncology Department
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3rd University Department of Internal Medicine
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
A’ Pathological Sector - Oncology Clinic
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@uth.gr
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology, Department of Medicine
Contact Person Name
Angelos Koutras
Contact Person Email
koutras@uop.gr

Netherlands

Earliest CTIS Part Ii Submission Date
22-05-2024
Latest Decision Or Authorization Date
10-06-2024
Processing Time Days
19
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Ziekenhuis Gelderse Vallei Stichting
Department Name
Pulmonology
Contact Person Name
Arthur Mulders
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Devisie Hart en Long
Contact Person Name
W.K. de Jong
Contact Person Email
w.k.dejong-9@umcutrecht
Site Name
Ziekenhuis St Jansdal
Department Name
Medical oncology
Contact Person Name
Lisenka Boom
Contact Person Email
LN.Boom@stjansdal.nl
Site Name
Ziekenhuisgroep Twente Stichting
Department Name
Pulmonology
Contact Person Name
Jeske Staal-van den Berkel
Contact Person Email
researchlong@zgt.nl
Site Name
Ziekenhuisgroep Twente Stichting
Department Name
Pulmonology
Contact Person Name
Jeske Staal-van den Berkel
Contact Person Email
researchlong@zgt.nl
Site Name
Isala Klinieken Stichting
Department Name
Medical oncology
Contact Person Name
P.M.J Plomp
Contact Person Email
p.m.j.plomp@isala.nl

Poland

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
14-06-2024
Processing Time Days
28
Number Of Sites
6
Number Of Participants
25

Sites

Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Anna Drosik-Kwaśniewska
Contact Person Email
biuro.mcm@pratia.com
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Oddział Wieloprofilowy Zachowawczy
Contact Person Name
Tomasz Jankowski
Contact Person Email
cwbk@umlub.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Contact Person Name
Jarosław KOŁB-SIELECKI
Contact Person Email
sekretariat@wmccp.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Płuca i Klatki Piersiowej
Contact Person Name
Dariusz Kowalski
Contact Person Email
paulina.kukwa@nio.gov.pl
Site Name
Szpital Specjalistyczny Im. Henryka Klimontowicza W Gorlicach
Department Name
Oddział Onkologii Klinicznej i Hematologii z Pododdziałem Dziennym Chemioterapii
Contact Person Name
Łukasz Pierzchała
Contact Person Email
l.pierzchala@gmail.com

Austria

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
22-09-2024
Processing Time Days
12
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Medical University Of Graz
Department Name
Klinische Abteilung für Pulmonologie
Contact Person Name
Robert Wurm
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Abteilung für Innere Medizin und Pneumologie
Contact Person Name
Maximilian Hochmair

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon (Lr) Limited
Responsibilities
sponsorDuties codes: 4
Name
Bioclinica Inc.
Responsibilities
central imaging
Name
Syneos Health Clinique Inc.
Responsibilities
sponsorDuties codes: 4
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Hematogenix Laboratory Services LLC
Responsibilities
sponsorDuties codes: 4
Name
Eresearchtechnology Inc.
Responsibilities
sponsorDuties codes: 7
Name
Almac Clinical Technologies LLC
Responsibilities
sponsorDuties codes: 3

Third parties

  • {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Marketing authorisation in EU (product dictionary shows EU authorisation details)
Maximum Dose
200 mg (maxDailyDoseAmount)
Investigational Product Name
MK-1084
Active Substance
MK-1084
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Investigational / no marketing authorisation listed for study use
Investigational Product Name
Placebo to MK-1084 25 MG
Modality
Other
Investigational Product Name
Placebo to MK-1084 50 mg
Modality
Other
Combination Treatment
Yes

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