Clinical trial • Phase III • Oncology

SACITUZUMAB TIRUMOTECAN for Metastatic non-small cell lung cancer (NSCLC)

Phase III trial of SACITUZUMAB TIRUMOTECAN for Metastatic non-small cell lung cancer (NSCLC).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic non-small cell lung cancer (NSCLC)
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody

Key dates

Initial CTIS Submission Date
02-11-2023
First CTIS Authorization Date
12-03-2024

Trial design

Randomised, open-label, arm a: mk-2870 (sacituzumab tirumotecan) intravenous infusion (product mk-2870; dose unit mg/kg; max daily dose listed 4 mg/kg) in combination with pembrolizumab (keytruda 25 mg/ml concentrate for solution for infusion; intravenous infusion; maximum dose listed 400 mg) versus arm b: pembrolizumab (keytruda) monotherapy (intravenous infusion; marketing authorisation eu/1/15/1024/002).-controlled Phase III trial in Denmark, Czechia, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: MK-2870 (sacituzumab tirumotecan) intravenous infusion (product MK-2870; dose unit mg/kg; max daily dose listed 4 mg/kg) in combination with pembrolizumab (KEYTRUDA 25 mg/mL concentrate for solution for infusion; intravenous infusion; maximum dose listed 400 mg) versus Arm B: pembrolizumab (KEYTRUDA) monotherapy (intravenous infusion; marketing authorisation EU/1/15/1024/002).
Target Sample Size
455

Eligibility

Recruits 455 adults.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)\n- Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy\n- Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory\n- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization\n- A life expectancy of at least 3 months\n- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n- Known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n- Known intolerance to MK-2870 or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary\n- Known hypersensitivity to MK-2870 or other biologic therapy\n- Active autoimmune disease that has required systemic treatment in the past 2 years\n- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD\n- Active infection requiring systemic therapy\n- Has Grade ≥2 peripheral neuropathy\n- Concurrent active Hepatitis B and Hepatitis C virus infection\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease\n- History of allogeneic tissue/solid organ transplant\n- Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study\n- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)\n- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention\n- Received prior systemic anticancer therapy for their metastatic NSCLC\n- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\n- Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization\n- Received radiation therapy to the lung within 6 months of start of study intervention"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"To compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to OS"}

Secondary endpoints

  • {"endpoint_text":"- Progression free survival (PFS)","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- Objective Response (OR)","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- Change from Baseline in Global Health Status/Quality of Life (QOL) Score [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Items 29 and 30]","definition_or_measurement_approach":"Mean change from baseline in global health status/quality of life measured by EORTC QLQ-C30 (items 29 and 30)"}
  • {"endpoint_text":"- Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-C30 item 8 (dyspnea)"}
  • {"endpoint_text":"- Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-LC13 item 31 (cough)"}
  • {"endpoint_text":"- Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)","definition_or_measurement_approach":"Change from baseline measured by EORTC QLQ-LC13 item 40 (chest pain)"}
  • {"endpoint_text":"- Time to Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Items 29 and 30)","definition_or_measurement_approach":"Time to deterioration based on change from baseline in EORTC QLQ-C30 items 29 and 30"}
  • {"endpoint_text":"- TTD Based on Change from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)","definition_or_measurement_approach":"Time to deterioration based on change from baseline in EORTC QLQ-C30 item 8"}
  • {"endpoint_text":"- TTD Based on Change from Baseline in Cough Score (EORTC QLQ-LC13 Item 31)","definition_or_measurement_approach":"Time to deterioration based on change from baseline in EORTC QLQ-LC13 item 31"}
  • {"endpoint_text":"- TTD Based on Change from Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)","definition_or_measurement_approach":"Time to deterioration based on change from baseline in EORTC QLQ-LC13 item 40"}
  • {"endpoint_text":"- Percentage of Participants that Experience at Least One Adverse Event (AE)","definition_or_measurement_approach":"Proportion of participants experiencing ≥1 AE"}
  • {"endpoint_text":"- Percentage of Participants who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Proportion of participants discontinuing study treatment because of an AE"}

Recruitment

Planned Sample Size
455
Recruitment Window Months
75
Consent Approach
Informed consent is obtained from each participant using country-specific Subject Information and Informed Consent Forms (L1_ICF_Main consent documents are available for Denmark, Czechia, Poland, Spain, France, Italy, Portugal, Netherlands, Germany, etc.). Optional consent components and addenda are included (examples in document list: optional limited screening consent, optional pregnancy follow-up, genetic consent, addendum disease progression, prescreening consent). Consent materials are provided in local languages as indicated by country-specific ICF documents.

Geography

Total Number Of Sites
60
Total Number Of Participants
196

Denmark

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
783
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Odense University Hospital
Department Name
Department of Oncology R, Clinical Research Unit
Contact Person Name
Lotte Holm Land
Contact Person Email
ouh.ode.r.ctis@rsyd.dk
Site Name
Aalborg University Hospital
Department Name
Department of Oncology
Contact Person Name
Tine McCulloch
Contact Person Email
tine.mcculloch@rn.dk
Site Name
Region Midtjylland
Department Name
Department of Oncology
Contact Person Name
Trine Heide Øllegaard
Contact Person Email
trine.oellegaard@auh.rm.dk

Czechia

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
784
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Nemocnice AGEL Ostrava-Vitkovice a.s.
Department Name
Plicní oddělení
Contact Person Name
Jaromír Roubec
Contact Person Email
jaromir.roubec@vtn.agel.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologická klinika
Contact Person Name
Milada Zemanová
Contact Person Email
milada.zemanova@vfn.cz
Site Name
University Hospital Olomouc
Department Name
Klinika plicních nemocí a tuberkulózy
Contact Person Name
Juraj Kultan
Contact Person Email
juraj.kultan@fnol.cz
Site Name
Multiscan s.r.o.
Department Name
Onkologické a radiologické centrum
Contact Person Name
Karel Odrážka
Contact Person Email
odrazka@multiscan.cz

Poland

Earliest CTIS Part Ii Submission Date
23-02-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
780
Number Of Sites
7
Number Of Participants
32

Sites

Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Contact Person Name
Anna Kowalczyk-Tekiela
Contact Person Email
atekiela@interia.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
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
Department Name
Oddział Onkologii Klinicznej
Contact Person Name
Uszula Sadowska
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
National Institute Of Tuberculosis And Lung Diseases
Department Name
III Klinika Chorób Płuc i Onkologii
Contact Person Name
Mateusz Polaczek
Contact Person Email
3klinika@igichp.edu.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski
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
dariusz.kowalski@nio.gov.pl

Spain

Earliest CTIS Part Ii Submission Date
20-11-2023
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
875
Number Of Sites
9
Number Of Participants
22

Sites

Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology
Contact Person Name
Elena Almagro Casado
Contact Person Email
elena.almagro@quironsalud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Reyes Bernabe Caro
Contact Person Email
bernabeensayos@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Hospital Universitario Nuestra Senora De Candelaria
Department Name
Oncology
Contact Person Name
Karla Mercedes Medina Sanchez
Contact Person Email
Karlamedinas510@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Sergio Sandiego Contreras
Contact Person Email
ssandiego@fivo.org
Site Name
Hospital De Jerez De La Frontera
Department Name
Oncology
Contact Person Name
Jesús Corral Jaime
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncology
Contact Person Name
María Rosario García Campelo
Site Name
Hospital Universitario De La Princesa
Department Name
Oncology
Contact Person Name
Berta Hernández Marín
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Enriqueta Felip Font
Contact Person Email
efelip@vhio.net

Germany

Earliest CTIS Part Ii Submission Date
30-01-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
800
Number Of Sites
12
Number Of Participants
36

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Infektiologie/Pneumologie Charité
Contact Person Name
Nicolaj Frost
Contact Person Email
studien-pneumologie@charite.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik für Pneumologie
Contact Person Name
Jürgen Alt
Site Name
Westfaelische Wilhelms-Universitaet Muenster
Department Name
Medizinische Klinik A - Hämatologie, Onkologie und Pneumologie
Contact Person Name
Annalen Bleckmann
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
SRH Wald-Klinikum Gera GmbH
Contact Person Name
Dagmar Täuscher
Contact Person Email
studienzentrum.wkg@srh.de
Site Name
Studienzentrum Onkologie Ravensburg GmbH
Department Name
Studienzentrum Onkologie Ravensburg GmbH
Contact Person Name
Tobias Dechow
Contact Person Email
dechow@onkonet.eu
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik V, Pneumologie, Thorakale Onkologie
Contact Person Name
Amanda Tufmann
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Pneumologie
Contact Person Name
Heiko Golpon
Contact Person Email
Golpon.heiko@mh-hannover.de
Site Name
Philipps-Universitaet Marburg
Department Name
Anneliese Pohl Krebszentrum Marburg, Comprehensive Cancer Center
Contact Person Name
Charis Faoro
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Pneumologie und Pneumologische Onkologie
Contact Person Name
Konrad Kokowski
Site Name
Klinikum Nuernberg
Department Name
Klinik für Innere Medizin 3, Schwerpunkt Pneumologie
Contact Person Name
Wolfgang Brückl
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
LungenClinic Grosshansdorf GmbH
Contact Person Name
Martin Reck
Contact Person Email
a.gaebler@lungenclinic.de
Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
Stifung Krankenhaus Bethanien Für Die Grafschaft Moers
Contact Person Name
Karl-Otto Kambartel

France

Earliest CTIS Part Ii Submission Date
23-01-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
806
Number Of Sites
8
Number Of Participants
32

Sites

Site Name
Clinique de l'Europe
Department Name
Department of Pneumology
Contact Person Name
Charles Dayen
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Institut Regional Du Cancer De Montpellier
Contact Person Name
Xavier Quantin
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Unité d'oncologie thoracique et cutané
Contact Person Name
Thomas Egenod
Contact Person Email
thomas.egenod@chu-limoges.fr
Site Name
Les Hopitaux Nord-Ouest
Department Name
Service de Pneumologie et Cancérologie Thoracique
Contact Person Name
Lionel Falchero
Contact Person Email
lfalchero@lhopitalnordouest.fr
Site Name
Hopital Saint Joseph
Department Name
Oncologie Thoracique
Contact Person Name
Arnaud Boyer
Contact Person Email
aboyer@hopital-saint-joseph.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Service de Pneumologie
Contact Person Name
Marielle Sabatini
Contact Person Email
msabatini@ch-cotebasque.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Pôle Régional de Cancérologie
Contact Person Name
Hela SKHIRI
Contact Person Email
hela.skhiri@chu-poitiers.fr
Site Name
Medipole De Nancy
Department Name
Medical Oncology
Contact Person Name
Fabien Brocard
Contact Person Email
f.brocard@ilcgroupe.fr

Italy

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
790
Number Of Sites
8
Number Of Participants
23

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Oncologia Medica
Contact Person Name
Lorenzo Antonuzzo
Contact Person Email
lorenzo.antonuzzo@gmail.com
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Dipartimento di Oncoematologia
Contact Person Name
Salvatore Intaglata
Contact Person Email
sintagliata@asst-pg23.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Oncologia Medica
Contact Person Name
Emilio Bria
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@teseo.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Oncology Department
Contact Person Name
Giacomo Pellizzari
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
S.O.C. Oncologia Medica
Contact Person Name
Vito Barbieri
Contact Person Email
vitobarbieri@yahoo.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica 1
Contact Person Name
Giuseppe Lo Russo

Portugal

Earliest CTIS Part Ii Submission Date
22-02-2024
Latest Decision Or Authorization Date
09-04-2026
Processing Time Days
777
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Ana Barroso
Contact Person Email
abarroso@chvng.min-saude.pt
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Telma Sequeira
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Serviço de Oncologia
Contact Person Name
Mafalda Costa
Site Name
Hospital Cuf Tejo S.A.
Department Name
Serviço de Oncologia
Contact Person Name
Simão Torres
Contact Person Email
simao.torres@cuf.pt
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Pneumologia - Unidade Pneumologia Oncológica
Contact Person Name
Paula Alves
Site Name
Servico de Saude da Regiao Autonoma Da Madeira EPERAM
Department Name
Serviço de Oncologia
Contact Person Name
Carolina Camacho
Contact Person Email
carolina.camacho@sesaram.pt

Netherlands

Earliest CTIS Part Ii Submission Date
16-02-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
782
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Isala Klinieken Stichting
Department Name
Pulmonary medicine
Contact Person Name
Peter Plomp
Contact Person Email
p.m.j.plomp@isala.nl
Site Name
St. Elisabeth Hospital Tilburg
Department Name
Pulmonary medicine
Contact Person Name
Mart Schiefer
Contact Person Email
ETZ_NL_lung_trial@etz.nl
Site Name
Amphia Hospital
Department Name
Pulmonary medicine
Contact Person Name
Kornelis van der Leest

Sponsor

Primary sponsor

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

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Central imaging; Provides Central Adjudication Services
Name
Iqvia Laboratories Limited
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Pharmaceutical Product Development LLC
Name
Eresearchtechnology Inc.
Name
Frontage Laboratories Inc.
Name
Signant Health Global Solutions Limited
Name
Roche Diagnostics GmbH

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"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":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Provides Central Adjudication Services","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Roche Diagnostics GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-2870
Active Substance
SACITUZUMAB TIRUMOTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Maximum Dose
4 mg/kg (max daily dose amount listed)
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: EU/1/15/1024/002
Maximum Dose
400 mg (max daily dose amount listed)
Combination Treatment
Yes

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