Clinical trial • Phase III • Oncology
PEMBROLIZUMAB for Melanoma | Non-small cell lung cancer | Non-squamous non-small cell lung cancer
Phase III trial of PEMBROLIZUMAB for Melanoma | Non-small cell lung cancer | Non-squamous non-small cell lung cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Melanoma | Non-small cell lung cancer | Non-squamous non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 07-06-2024
- First CTIS Authorization Date
- 16-09-2024
Trial design
open-label, none/not specified-controlled Phase III trial across 27 sites in Spain, Lithuania, Romania.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 454
- Trial Duration For Participant
- 730
Eligibility
Recruits 454 adults.
Inclusion criteria
- {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study."}
- {"criterion_text":"- Participant must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) on the day of signing informed consent."}
- {"criterion_text":"- Participants of Study 101 or Study 301 who are judged to benefit from continued treatment with pembrolizumab by their Investigator."}
- {"criterion_text":"- Participants who have demonstrated compliance with Study 101 or Study 301 protocol requirements as assessed by their Investigator."}
- {"criterion_text":"- Participants who completed Study 101 or Study 301 as per protocol OR who discontinued treatment and consequently study participation in Study 101 or 301 Note: Examples for discontinued participants: • Study 101, e.g. participants who did not receive pembrolizumab within the predefined visit schedule window, • Study 301, e.g. participants with unacceptable toxicity to background chemotherapy Cis-/Carboplatin and/or Pemetrexed."}
- {"criterion_text":"- Participants who discontinued from Study 301 based on Sponsor´s decision to terminate Study 301"}
Exclusion criteria
- {"criterion_text":"- Participants who experienced disease recurrence during Study 101 or Study 301"}
- {"criterion_text":"- Participants who experienced disease progression during Study 301"}
- {"criterion_text":"- Participants who experienced unacceptable toxicity related to pembrolizumab during Study 101 or Study 301"}
- {"criterion_text":"- Participants who have full reimbursable access to Keytruda for their indication."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Cohort A (Melanoma): SAEs up to 6 – 12 months (EOS/ED) after start of treatment in Study 302 Cohort B (NSCLC): SAEs up to 12- 24 months (EOS/ED) after start of treatment in Study 302","definition_or_measurement_approach":"To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEs; measured as occurrence of SAEs within the cohort-specific time windows (Cohort A: up to 6–12 months; Cohort B: up to 12–24 months after start of treatment in Study 302)."}
Recruitment
- Planned Sample Size
- 454
- Recruitment Window Months
- 31
- Consent Approach
- Signed informed consent must be obtained prior to participation in the study. Participants must be at least 18 years of age (or the legal age of consent in the jurisdiction). Country- and cohort-specific informed consent forms are provided (documents available in English, Spanish, Lithuanian, Romanian and country/cohort specific ICFs for Cohort A and Cohort B). No assent process for minors is described in the available material.
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 75
Spain
- Earliest CTIS Part Ii Submission Date
- 04-04-2025
- Latest Decision Or Authorization Date
- 26-09-2025
- Processing Time Days
- 175
- Number Of Sites
- 15
- Number Of Participants
- 29
Sites
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- 3614: Oncología Médica
- Principal Investigator Name
- Isidoro Carlos Barneto Aranda
- Principal Investigator Email
- isidoroc.barneto.sspa@juntadeandalucia.es
- Contact Person Name
- Isidoro Carlos Barneto Aranda
- Contact Person Email
- isidoroc.barneto.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- 3612: Oncología Médica
- Principal Investigator Name
- Emilio Esteban González
- Principal Investigator Email
- eestebang@seom.org
- Contact Person Name
- Emilio Esteban González
- Contact Person Email
- eestebang@seom.org
- Site Name
- Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
- Department Name
- 3613: Oncología Médica
- Principal Investigator Name
- Margarita Amenedo Gancedo
- Principal Investigator Email
- margarita.amenedo@cog.es
- Contact Person Name
- Margarita Amenedo Gancedo
- Contact Person Email
- margarita.amenedo@cog.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- 3607; Oncología Médica
- Principal Investigator Name
- Teresa Curiel Garcia
- Principal Investigator Email
- teresa.curiel.garcia@sergas.es
- Contact Person Name
- Teresa Curiel Garcia
- Contact Person Email
- teresa.curiel.garcia@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- 3602; Oncología Médica
- Principal Investigator Name
- Margarita Majem Tarruella
- Principal Investigator Email
- mmajem@santpau.cat
- Contact Person Name
- Margarita Majem Tarruella
- Contact Person Email
- mmajem@santpau.cat
- Site Name
- Hospital San Pedro De Alcantara
- Department Name
- 3611; Oncología
- Principal Investigator Name
- Pablo Ayala
- Principal Investigator Email
- pablo.ayala@salud-juntaex.es
- Contact Person Name
- Pablo Ayala
- Contact Person Email
- pablo.ayala@salud-juntaex.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- 3610; Oncología Médica
- Principal Investigator Name
- Luis de la Cruz Merino
- Principal Investigator Email
- luis.cruz.sspa@juntadeandalucia.es
- Contact Person Name
- Luis de la Cruz Merino
- Contact Person Email
- luis.cruz.sspa@juntadeandalucia.es
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- 3600; Oncología
- Principal Investigator Name
- Pablo Cerezuela Fuentes
- Principal Investigator Email
- pcerezuelaf@seom.org
- Contact Person Name
- Pablo Cerezuela Fuentes
- Contact Person Email
- pcerezuelaf@seom.org
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- 3609; Onco-Hematologia Pediatrica
- Principal Investigator Name
- Roberto Pedro Diaz Beveridge
- Principal Investigator Email
- diaz_rob@gva.es
- Contact Person Name
- Roberto Pedro Diaz Beveridge
- Contact Person Email
- diaz_rob@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- 3601; Oncología Médica
- Principal Investigator Name
- Augusto Alejandro Valdivia Bustamante
- Principal Investigator Email
- augustovaldivia@vhio.net
- Contact Person Name
- Augusto Alejandro Valdivia Bustamante
- Contact Person Email
- augustovaldivia@vhio.net
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- 3606; Oncología
- Principal Investigator Name
- Maria José Juan Fita
- Principal Investigator Email
- mjjuan@fivo.org
- Contact Person Name
- Maria José Juan Fita
- Contact Person Email
- mjjuan@fivo.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- 3604; Oncología Médica
- Principal Investigator Name
- Manuel Pedregal Trujillo
- Principal Investigator Email
- Manuel.pedregal@startmadrid.com
- Contact Person Name
- Manuel Pedregal Trujillo
- Contact Person Email
- Manuel.pedregal@startmadrid.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- 3603; Oncología Médica
- Principal Investigator Name
- José Luis Manzano Mozo
- Principal Investigator Email
- jmanzano@iconcologia.net
- Contact Person Name
- José Luis Manzano Mozo
- Contact Person Email
- jmanzano@iconcologia.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- 3608; Oncología
- Principal Investigator Name
- Alejandro Falcón González
- Principal Investigator Email
- alejandro.falcon.sspa@juntadeandalucia.es
- Contact Person Name
- Alejandro Falcón González
- Contact Person Email
- alejandro.falcon.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- 3605; Oncología
- Principal Investigator Name
- Teresa Puertolas Hernandez
- Principal Investigator Email
- tjpuertolas@gmail.com
- Contact Person Name
- Teresa Puertolas Hernandez
- Contact Person Email
- tjpuertolas@gmail.com
Lithuania
- Earliest CTIS Part Ii Submission Date
- 25-02-2025
- Latest Decision Or Authorization Date
- 23-09-2025
- Processing Time Days
- 210
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Nacionalinis vezio institutas
- Department Name
- #2601: Conservative Tumour Therapy
- Principal Investigator Name
- Vincas Urbonas
- Principal Investigator Email
- vincas.urbonas@nvi.lt
- Contact Person Name
- Vincas Urbonas
- Contact Person Email
- vincas.urbonas@nvi.lt
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- #2600: Chemotherapy
- Principal Investigator Name
- Alvydas Cesas
- Principal Investigator Email
- cesasalvydas@gmail.com
- Contact Person Name
- Alvydas Cesas
- Contact Person Email
- cesasalvydas@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 13-10-2025
- Processing Time Days
- 480
- Number Of Sites
- 10
- Number Of Participants
- 36
Sites
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- 3210: Oncology
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- mike_schenker@yahoo.com
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Centrul De Oncologie-Euroclinic S.R.L.
- Department Name
- 3208: Oncology
- Principal Investigator Name
- Constantin Volovat
- Principal Investigator Email
- cvolovat@yahoo.com
- Contact Person Name
- Constantin Volovat
- Contact Person Email
- cvolovat@yahoo.com
- Site Name
- Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
- Department Name
- 3200: Medical Oncology II Department, Radiotherapy I Department
- Principal Investigator Name
- Laurentia Gales
- Principal Investigator Email
- laurentia.gales.ext@arensia-em.com
- Contact Person Name
- Laurentia Gales
- Contact Person Email
- laurentia.gales.ext@arensia-em.com
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- 3201: Radiotherapy Department
- Principal Investigator Name
- Tudor Ciuleanu
- Principal Investigator Email
- tudor_ciuleanu@hotmail.com
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
- Site Name
- Medisprof S.R.L.
- Department Name
- 3202: Oncology
- Principal Investigator Name
- Anghel Adrian Udrea
- Principal Investigator Email
- adrianudrea@medisprof.ro
- Contact Person Name
- Anghel Adrian Udrea
- Contact Person Email
- adrianudrea@medisprof.ro
- Site Name
- Radiotherapy Center Cluj S.R.L.
- Department Name
- 3203: Oncology
- Principal Investigator Name
- Andrei Ungureanu
- Principal Investigator Email
- andrei.ungureanu@amethyst-radiotherapy.com
- Contact Person Name
- Andrei Ungureanu
- Contact Person Email
- andrei.ungureanu@amethyst-radiotherapy.com
- Site Name
- Onco Clinic Consult S.A.
- Department Name
- 3207: Oncology
- Principal Investigator Name
- Patricia Visan
- Principal Investigator Email
- p.visan@oncoclinic.ro
- Contact Person Name
- Patricia Visan
- Contact Person Email
- p.visan@oncoclinic.ro
- Site Name
- Oncolab S.R.L.
- Department Name
- 3206: Medical oncology
- Principal Investigator Name
- Dan Lungulescu
- Principal Investigator Email
- dan.lungulescu@yahoo.com
- Contact Person Name
- Dan Lungulescu
- Contact Person Email
- dan.lungulescu@yahoo.com
- Site Name
- Oncocenter Oncologie Clinica S.R.L.
- Department Name
- 3204: Oncology
- Principal Investigator Name
- Roxana Scheusan
- Principal Investigator Email
- roxana.scheusan@oncocenter.ro
- Contact Person Name
- Roxana Scheusan
- Contact Person Email
- roxana.scheusan@oncocenter.ro
- Site Name
- Oncomed S.R.L.
- Department Name
- 3205: Medical Oncology
- Principal Investigator Name
- Daniela Sirbu
- Principal Investigator Email
- desirbu@yahoo.com
- Contact Person Name
- Daniela Sirbu
- Contact Person Email
- desirbu@yahoo.com
Sponsor
Primary sponsor
- Full Name
- H e x a l AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: 1,10,11,12,13,14,2,5,6,7,8
Third parties
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,14,2,5,6,7,8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- pembrolizumab
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Maximum Dose
- 400 mg (max daily dose amount); max total amount 3200 mg
- Investigational Product Name
- Pemetrexed STADA® 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- PEMETREXED DISODIUM HEMIPENTAHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Maximum Dose
- 500 mg/m2 (max daily dose amount); max total amount 17000 mg/m2
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