Clinical trial • Phase I/II • Oncology

Avelumab for Gestational trophoblastic neoplasia (low-risk)

Phase I/II trial of Avelumab for Gestational trophoblastic neoplasia (low-risk). None/Not specified-controlled. 26 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Gestational trophoblastic neoplasia (low-risk)
Trial Stage
Phase I/II
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
05-07-2024
First CTIS Authorization Date
06-08-2024

Trial design

None/Not specified-controlled Phase I/II trial across 9 sites in France.

Comparator
None/Not specified
Target Sample Size
26

Recruitment

Planned Sample Size
26
Recruitment Window Months
37

Geography

Total Number Of Sites
9
Total Number Of Participants
26

France

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
31-01-2025
Processing Time Days
203
Number Of Sites
9
Number Of Participants
26

Sites

Site Name
Hospices Civils De Lyon
Department Name
Oncologie médicale
Principal Investigator Name
Benoit You
Principal Investigator Email
benoit.you@chu-lyon.fr
Contact Person Name
Benoit You
Contact Person Email
benoit.you@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie médicale
Principal Investigator Name
Jean-Pierre LOTZ
Principal Investigator Email
jean-pierre.lotz@tnn.aphp.fr
Contact Person Name
Jean-Pierre LOTZ
Contact Person Email
jean-pierre.lotz@tnn.aphp.fr
Site Name
Centre de Coordination en Cancérologie François Baclesse
Department Name
Oncologie médicale
Principal Investigator Name
Florence JOLY
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence JOLY
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut Bergonie
Department Name
ONCOLOGIE MEDICALE
Principal Investigator Name
Coriolan LEBRETON
Principal Investigator Email
c.lebretont@bordeaux.unicancer.fr
Contact Person Name
Coriolan LEBRETON
Site Name
Institut Paoli Calmettes
Department Name
Oncologie médicale
Principal Investigator Name
Magali PROVANSAL
Principal Investigator Email
provansalm@ipc.unicancer.fr
Contact Person Name
Magali PROVANSAL
Contact Person Email
provansalm@ipc.unicancer.fr
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie médicale
Principal Investigator Name
Philippe FOLLANA
Principal Investigator Email
PHILIPPE.FOLLANA@NICE.UNICANCER.FR
Contact Person Name
Philippe FOLLANA
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie médicale
Principal Investigator Name
Laurence GLADIEFF
Principal Investigator Email
gladieff.laurence@iuct-oncopole.fr
Contact Person Name
Laurence GLADIEFF
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
Oncologie médicale
Principal Investigator Name
Thibault DE LA MOTTE ROUGE
Principal Investigator Email
t.delamotterouge@rennes.unicancer.fr
Contact Person Name
Thibault DE LA MOTTE ROUGE
Site Name
Hospices Civils De Lyon
Department Name
Oncologie médicale
Principal Investigator Name
Benoit You
Principal Investigator Email
benoit.you@chu-lyon.fr
Contact Person Name
Benoit You
Contact Person Email
benoit.you@chu-lyon.fr

Sponsor

Primary sponsor

Full Name
Hospices Civils De Lyon
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Avelumab
Active Substance
Avelumab
Modality
Monoclonal antibody
Investigational Product Name
Methotrexate
Active Substance
Methotrexate
Modality
Small molecule
Combination Treatment
Yes

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