Clinical trial • Phase III • Oncology
AVELUMAB for Cancer
Phase III trial of AVELUMAB for Cancer. open-label, none/not specified-controlled. 44 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cancer
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 10-07-2024
- First CTIS Authorization Date
- 07-08-2024
Trial design
open-label, none/not specified-controlled Phase III trial across 13 sites in Belgium, Denmark, France and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 44
Eligibility
Recruits 44 No vulnerable populations selected. Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3..
- Pregnancy Exclusion
- 1. Female participants who are pregnant or breastfeeding.
- Vulnerable Population
- No vulnerable populations selected. Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3.
Inclusion criteria
- {"criterion_text":"- 1. Any participant who is receiving study treatment and deriving significant clinical benefit (as determined by the Principal Investigator) or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study."}
- {"criterion_text":"- 2. 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 Avelumab Continuation Sub-Study Protocol."}
- {"criterion_text":"- 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the appliable Avelumab Continuation Sub- Study Protocol."}
- {"criterion_text":"- 4. 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":"- 1. Female participants who are pregnant or breastfeeding."}
- {"criterion_text":"- 2. 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 intervention","definition_or_measurement_approach":""}
- {"endpoint_text":"- All SAEs","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 44
- Recruitment Window Months
- 54
- Consent Approach
- Participants must be capable of giving signed informed consent as described in Appendix 1, Section 10.1.3. Subject information and informed consent forms (ICFs) are provided in multiple languages (English, Danish, French, Spanish, Polish, Hungarian, Italian, Dutch) across country-specific documents.
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 14
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-08-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 613
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Oncology and Hematology Department
- Contact Person Name
- Jean-Luc Canon
- Contact Person Email
- Jean-Luc.Canon@ghdc.be
- Number Of Participants
- 1
Denmark
- Earliest CTIS Part Ii Submission Date
- 13-08-2024
- Latest Decision Or Authorization Date
- 13-08-2024
- Processing Time Days
- 0
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Aalborg University Hospital
- Contact Person Name
- Andreas Carus
- Contact Person Email
- andreas.carus@rn.dk
- Number Of Participants
- 1
France
- Earliest CTIS Part Ii Submission Date
- 03-09-2024
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 440
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Institut De Cancerologie De Lorraine
- Contact Person Name
- Yolanda Fernandez
- Contact Person Email
- y.fernandez@nancy.unicancer.fr
- Number Of Participants
- 1
Hungary
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 16-04-2025
- Processing Time Days
- 247
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Országos Onkológiai Intézet Department: Kemoterápia B
- Contact Person Name
- Gabor Rubovszky
- Contact Person Email
- garub@oncol.hu
- Number Of Participants
- 1
Italy
- Earliest CTIS Part Ii Submission Date
- 16-09-2024
- Latest Decision Or Authorization Date
- 10-04-2026
- Processing Time Days
- 571
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Struttura Complessa Oncologia Medica 1
- Contact Person Name
- Elena Verzoni
- Contact Person Email
- Elena.Verzoni@Istitutotumori.Mi.It
- Number Of Participants
- 1
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- UO Oncologia medica ed Ematologia
- Contact Person Name
- Armando Santoro
- Contact Person Email
- trials.santoro@cancercenter.humanitas.it
- Number Of Participants
- 1
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Contact Person Name
- Silvia Damian
- Contact Person Email
- silvia.damian@istitutotumori.mi.it
- Number Of Participants
- 1
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica Oncologica
- Contact Person Name
- Rossana Berardi
- Contact Person Email
- rossana.berardi@ospedaliriuniti.marche.it
- Number Of Participants
- 0
Spain
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 614
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- Ampliacion. Unidad de Oncologia. Planta baja
- Contact Person Name
- Jose Fuentes Pradera
- Contact Person Email
- fuentespradera@hotmail.com
- Number Of Participants
- 2
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Edificio General Servicio de Oncologia
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Number Of Participants
- 2
- Site Name
- Hospital Universitari Vall D Hebron
- Contact Person Name
- Rafael Morales Barrer
- Contact Person Email
- rmorales@vhio.net
- Number Of Participants
- 1
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- START Madrid FJD.Phase 1 Trials
- Contact Person Name
- Bernard Doger de Speville Uribe
- Contact Person Email
- Bernard.doger@startmadrid.com
- Number Of Participants
- 1
Poland
- Earliest CTIS Part Ii Submission Date
- 09-08-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 612
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Contact Person Name
- Pawel Nurzynski
- Contact Person Email
- pawenur@gmail.com
- Number Of Participants
- 1
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- Site monitoring, Site Contract Amendment Negotiations, EC/IRB submission/preparation
Third parties
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Site monitoring, Site Contract Amendment Negotiations, EC/IRB submission/preparation","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- AVELUMAB
- Active Substance
- AVELUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Maximum Dose
- 1200 mg
- Investigational Product Name
- LORLATINIB
- Active Substance
- LORLATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Maximum Dose
- 100 mg
- Investigational Product Name
- AXITINIB
- Active Substance
- AXITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Maximum Dose
- 20 mg
- Investigational Product Name
- TALAZOPARIB
- Active Substance
- TALAZOPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Maximum Dose
- 1 mg
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