Clinical trial • Phase II • Oncology

Durvalumab for Solid tumours|Solid tumours with homologous recombination repair (HRR) gene mutation

Phase II trial of Durvalumab for Solid tumours|Solid tumours with homologous recombination repair (HRR) gene mutation. None/Not specified-controlled.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Solid tumours|Solid tumours with homologous recombination repair (HRR) gene mutation
Trial Stage
Phase II
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
26-09-2024
First CTIS Authorization Date
15-10-2024

Trial design

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

Comparator
None/Not specified
Biomarker Stratified
True, biomarker: homologous recombination repair (HRR) gene mutation
Target Sample Size
230

Eligibility

Recruits 230 No vulnerable population selected; consent/assent handling not specified..

Vulnerable Population
No vulnerable population selected; consent/assent handling not specified.

Recruitment

Planned Sample Size
230
Recruitment Window Months
64

Geography

Total Number Of Sites
9
Total Number Of Participants
230

France

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
460
Number Of Sites
9
Number Of Participants
230

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
Oncology
Principal Investigator Name
François GHIRINGHELLI
Principal Investigator Email
fghiringhelli@cgfl.fr
Contact Person Name
François GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
IHFB Cognacq Jay
Department Name
Oncology
Principal Investigator Name
Benoist CHIBAUDEL
Principal Investigator Email
benoist.chibaudel@ihfb.org
Contact Person Name
Benoist CHIBAUDEL
Contact Person Email
benoist.chibaudel@ihfb.org
Site Name
Centre Oscar Lambret
Department Name
Oncology
Principal Investigator Name
Nicolas PENEL
Principal Investigator Email
n-penel@o-lambret.fr
Contact Person Name
Nicolas PENEL
Contact Person Email
n-penel@o-lambret.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncology
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
Centre Leon Berard
Department Name
Oncology
Principal Investigator Name
Olivier TREDAN
Principal Investigator Email
olivier.tredan@lyon.unicancer.fr
Contact Person Name
Olivier TREDAN
Site Name
Institut Bergonie
Department Name
Oncology
Principal Investigator Name
Antoine ITALIANO
Principal Investigator Email
a.italiano@bordeaux.unicancer.fr
Contact Person Name
Antoine ITALIANO
Site Name
CHU Besancon
Department Name
Oncology
Principal Investigator Name
Angélique VIENOT
Principal Investigator Email
angelique.vienot@chu-besancon.fr
Contact Person Name
Angélique VIENOT
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
HGE
Principal Investigator Name
Antoine DROUILLARD
Principal Investigator Email
antoine.drouillard@chu-dijon.fr
Contact Person Name
Antoine DROUILLARD
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncology
Principal Investigator Name
Nicolas ISAMBERT
Principal Investigator Email
nicolas.isambert@chu-poitiers.fr
Contact Person Name
Nicolas ISAMBERT

Sponsor

Primary sponsor

Full Name
Centr Georges Francois Leclerc
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Durvalumab
Active Substance
Durvalumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Investigational Product Name
Tremelimumab
Active Substance
Tremelimumab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Investigational Product Name
Olaparib
Active Substance
Olaparib
Modality
Small molecule
Routes Of Administration
Oral
Combination Treatment
Yes

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