Clinical trial • Phase III • Oncology

BI 3820768 for Advanced relapsed or refractory ovarian cancer|Advanced relapsed or refractory endometrial cancer|Advanced relapsed or refractory germ cell tumours

Phase III trial of BI 3820768 for Advanced relapsed or refractory ovarian cancer|Advanced relapsed or refractory endometrial cancer|Advanced relapsed or r…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced relapsed or refractory ovarian cancer|Advanced relapsed or refractory endometrial cancer|Advanced relapsed or refractory germ cell tumours
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
16-12-2025
First CTIS Authorization Date
20-04-2026

Trial design

Phase III trial across 7 sites in Germany, Belgium, France and others.

Target Sample Size
102

Recruitment

Planned Sample Size
102
Recruitment Window Months
38

Geography

Total Number Of Sites
7
Total Number Of Participants
102

Germany

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
13
Number Of Sites
2
Number Of Participants
28

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum mit ECTU
Principal Investigator Name
Cyrus Sayehli
Principal Investigator Email
sayehli_c@ukw.de
Contact Person Name
Cyrus Sayehli
Contact Person Email
sayehli_c@ukw.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Klinik für Geburtshilfe und Gynäkologie
Principal Investigator Name
Bastian Czogalla
Principal Investigator Email
bastian.czogalla@med.uni-muenchen.de
Contact Person Name
Bastian Czogalla

Belgium

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
27
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Department of Oncology, route 42
Principal Investigator Name
Jean-François Baurain
Contact Person Name
Jean-François Baurain

France

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
27
Number Of Sites
2
Number Of Participants
28

Sites

Site Name
Institut Paoli Calmettes
Department Name
Oncologie Médicale
Principal Investigator Name
Cecile Vicier
Principal Investigator Email
vicierc@ipc.unicancer.fr
Contact Person Name
Cecile Vicier
Contact Person Email
vicierc@ipc.unicancer.fr
Site Name
Institut Gustave Roussy
Department Name
Département de Médecine Oncologique
Principal Investigator Name
Kaissa Ouali
Principal Investigator Email
kaissa.ouali@gustaveroussy.fr
Contact Person Name
Kaissa Ouali
Contact Person Email
kaissa.ouali@gustaveroussy.fr

Spain

Earliest CTIS Part Ii Submission Date
25-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
33
Number Of Sites
2
Number Of Participants
37

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Unitat d’Investigació en Terapia Molecular (UITM)
Principal Investigator Name
Giulia Pretelli
Principal Investigator Email
giuliapretelli@vhio.net
Contact Person Name
Giulia Pretelli
Contact Person Email
giuliapretelli@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Antonio González
Principal Investigator Email
agonzalezma@unav.es
Contact Person Name
Antonio González
Contact Person Email
agonzalezma@unav.es

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
BI 3820768

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