Clinical trial • Not applicable • Oncology

encorafenib for Solid tumors

Not applicable trial of encorafenib for Solid tumors.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Solid tumors
Trial Stage
Not applicable
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
15-07-2024
First CTIS Authorization Date
27-08-2024

Trial design

open-label, pembrolizumab (concentrate for solution for injection, intravenous use) ; nivolumab (concentrate for solution for infusion, intravenous use) — dose/schedule not specified in the provided record-controlled Not applicable trial in France, Netherlands, Spain and others.

Open Label
Yes
Comparator
PEMBROLIZUMAB (concentrate for solution for injection, intravenous use) ; NIVOLUMAB (concentrate for solution for infusion, intravenous use) — dose/schedule not specified in the provided record
Target Sample Size
30

Eligibility

Recruits 30 Vulnerable population is selected. Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3; consent is provided by the participant (signed informed consent). No assent procedures for minors are described in the available criteria..

Vulnerable Population
Vulnerable population is selected. Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3; consent is provided by the participant (signed informed consent). No assent procedures for minors are described in the available criteria.

Inclusion criteria

  • {"criterion_text":"- Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment."}
  • {"criterion_text":"- Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol."}
  • {"criterion_text":"- Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol."}
  • {"criterion_text":"- Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol."}

Exclusion criteria

  • {"criterion_text":"- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- AEs leading to permanent discontinuation of study interventiona","definition_or_measurement_approach":"Adverse events leading to permanent discontinuation of study intervention; AEs collected and graded per standard AE reporting (NCI CTCAE referenced in protocol)."}
  • {"endpoint_text":"- All SAEs","definition_or_measurement_approach":"All serious adverse events (SAEs) captured and reported according to regulatory SAE definitions and the study's safety reporting procedures."}

Recruitment

Planned Sample Size
30
Recruitment Window Months
105
Consent Approach
Participants must provide signed informed consent as described in Appendix 1, Section 10.1.3; consent documents (ICDs/ICFs) are available in multiple languages (documents listed for EN, FR, ES, IT, NL, PT, HU, CZ, DE, GR). Consent is provided by the participant; the protocol references compliance with requirements and restrictions listed in the ICD and protocol.

Geography

Total Number Of Sites
38
Total Number Of Participants
71

France

Earliest CTIS Part Ii Submission Date
26-09-2024
Latest Decision Or Authorization Date
08-08-2025
Processing Time Days
316
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Institut Gustave Roussy
Contact Person Name
Caroline Robert

Netherlands

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
534
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Isala Klinieken Stichting
Contact Person Name
Jan Willem Berend de Groot
Contact Person Email
j.w.b.de.groot@isala.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Contact Person Name
A.J. de Langen
Contact Person Email
j.d.langen@nki.nl
Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Contact Person Name
Ingrid M.E. Desar
Contact Person Email
ingrid.desar@radboudumc.nl

Spain

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
534
Number Of Sites
13
Number Of Participants
21

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Centro integral Oncologico Clara Campal
Contact Person Name
Rafael Alvarez Gallego
Site Name
Hospital Clinic De Barcelona
Department Name
ICMHO Oncologia Medica
Contact Person Name
Ana Maria Arance Fernandez
Contact Person Email
amarance@clinic.cat
Site Name
Hospital Germans Trias I Pujol
Department Name
Servicio de Oncologia Medica
Contact Person Name
Jose Luis Manzano Mozo
Contact Person Email
jmanzano@iconcologia.net
Site Name
Hospital Universitario Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Servicio de Oncologia
Contact Person Name
Eleonor Paola Murata Yonamine
Contact Person Email
paolamurata@gmail.com
Site Name
Hospital Universitario Central De Asturias
Department Name
Servicio de Oncología
Contact Person Name
Isabel Palacio Vazquez
Contact Person Email
isabel.palacio@sespa.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Oncología
Contact Person Name
Alvaro Montesa Pino
Contact Person Email
amontesa76@hotmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Consultas Externas de Oncologia
Contact Person Name
Mariano Provencio Pulla
Site Name
Hospital Universitari Vall D Hebron
Department Name
ICMHO Oncologia Medica / Servicio de Oncologia Medica (two entries)
Contact Person Name
Josep Tabernero Caturla / Eva Munoz Couselo
Site Name
Hospital Teresa Herrera C.H.U.A.C.
Department Name
Servicio Oncología Médica
Contact Person Name
Maria Quindos Varela
Contact Person Email
Maria.Quindos.Varela@sergas.es
Site Name
Institut Catala D'oncologia
Department Name
Oncologia Médica
Contact Person Name
Laura Jimenez Colomo
Contact Person Email
ljcolomo@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncologia
Contact Person Name
Guillermo Antonio de Velasco Oria de Rueda
Contact Person Email
gdvelasco.gdv@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Servicio de Oncologia Medica
Contact Person Name
Marta Sotelo Garcia
Contact Person Email
marta.sotelo@scsalud.es

Hungary

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
540
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
University Of Pecs
Department Name
Bor-/ Nemikortani es Onkodermatologiai Klinika
Contact Person Name
Zsuzsanna Lengyel
Contact Person Email
Iengyel.zsuzsanna@pte.hu
Site Name
Orszagos Onkologiai Intezet
Department Name
Oncodermatology
Contact Person Name
Gabriella Lliszkay
Contact Person Email
liszkay.gabriella@oncol.hu
Site Name
University Of Debrecen
Department Name
Klinikai Központ - Department of Dermatology
Contact Person Name
Eva Remenyik
Contact Person Email
remenyik@med.unideb.hu
Site Name
Semmelweis University
Department Name
Bor-/ Nemikortani es Boronkologiai Klinika
Contact Person Name
Veronika Toth
Contact Person Email
toveroka@yahoo.com

Portugal

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
533
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Paula Silva Ferreira
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Medical Oncology Department
Contact Person Name
Patricia Matos Cruz da Silva Pereira
Contact Person Email
pmsilva@ipolisboa.min-saude.pt

Italy

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
528
Number Of Sites
9
Number Of Participants
25

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncology and Hematology
Contact Person Name
Stefania Salvagni
Contact Person Email
stefania.salvagni@aosp.bo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Contact Person Name
Michele Guida
Contact Person Email
m.guida@oncologico.bari.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
S.C. Onc. Clinica Sperimentale Del Melanoma – Immunoterapia e Terapie Innovative
Contact Person Name
Ester Simeone
Contact Person Email
ester.simeone@gmail.com
Site Name
IRCCS- Regina Elena National Cancer Institute
Contact Person Name
Virginia Ferraresi
Contact Person Email
virginia.ferraresi@ifo.it
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
GIC cutaneous tumors
Contact Person Name
Fabrizio Carnevale Schianca
Contact Person Email
fabrizio.carnevale@ircc.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncologia 2
Contact Person Name
Luisa Piccin
Contact Person Email
luisa.piccin@iov.veneto.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Contact Person Name
Ascierto, Paolo Antonio
Site Name
Azienda Ospedaliera Di Perugia
Department Name
Department of medical oncology
Contact Person Name
Mario Mandalà
Contact Person Email
mario.mandala@unipg.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology Melanoma, Sarcoma and Rare Tumors
Contact Person Name
Carolina Cimminiello
Contact Person Email
carolina.cimminiello@ieo.it

Germany

Earliest CTIS Part Ii Submission Date
28-08-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
532
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Contact Person Name
Thomas Kurt Eigentler
Contact Person Email
thomas.eigentler@charite.de
Site Name
Universitaetsklinikum Tuebingen AöR
Contact Person Name
Teresa Amaral
Site Name
Otto Von Guericke Universitaet Magdeburg
Contact Person Name
Thomas Tueting
Contact Person Email
thomas.tueting@med.ovgu.de

Czechia

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
542
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Dermatovenerologická klinika
Contact Person Name
Ivana Krajsova
Contact Person Email
ivana.krajsova@vfn.cz

Greece

Earliest CTIS Part Ii Submission Date
24-04-2026
Latest Decision Or Authorization Date
24-04-2026
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Laiko General Hospital Of Athens
Department Name
First Department of Internal Medicine
Contact Person Name
Helen Gogas
Contact Person Email
helgogas@gmail.com

Sponsor

Primary sponsor

Full Name
Pfizer Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Study Management; contact Kimberley.Clarke-Wynn@ppdi.com

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Study Management","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Encorafenib
Active Substance
encorafenib
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus: 1
Maximum Dose
maxDailyDoseAmount 450 mg (as provided)
Investigational Product Name
Braftovi 50 mg hard capsules
Active Substance
ENCORAFENIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
maxDailyDoseAmount 450 mg (as provided)
Investigational Product Name
Braftovi 75 mg hard capsules
Active Substance
ENCORAFENIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
maxDailyDoseAmount 450 mg (as provided)
Investigational Product Name
Mektovi 15 mg film-coated tablets
Active Substance
BINIMETINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
maxDailyDoseAmount 90 mg (as provided)
Investigational Product Name
Zelboraf 240 mg film-coated tablets
Active Substance
VEMURAFENIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
maxDailyDoseAmount 1920 mg (as provided)
Investigational Product Name
Erbitux 5 mg/mL solution for infusion
Active Substance
CETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
prodAuthStatus: 2
Maximum Dose
maxDailyDoseAmount 500 mg/m2 (as provided)
Investigational Product Name
Ribociclib
Active Substance
RIBOCICLIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus: 1
Maximum Dose
maxDailyDoseAmount 600 mg (as provided)
Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
prodAuthStatus: 2 (part1MpRoleTypeCode indicates comparator role in record)
Maximum Dose
maxDailyDoseAmount 7000 mg (as provided)
Investigational Product Name
NIVOLUMAB
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
prodAuthStatus: 2 (part1MpRoleTypeCode indicates comparator role in record)
Maximum Dose
maxDailyDoseAmount 11800 mg (as provided)
Combination Treatment
Yes

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