Clinical trial • Phase IV • Oncology
Nivolumab for Metastatic colorectal cancer
Phase IV trial of Nivolumab for Metastatic colorectal cancer. open-label. 30 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic colorectal cancer
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 23-08-2024
- First CTIS Authorization Date
- 07-10-2024
Trial design
open-label Phase IV trial across 9 sites in France.
- Open Label
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 Vulnerable population selected; no further details on consent or assent handling are provided in the record..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling are provided in the record.
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 93
- Consent Approach
- No information on informed consent or assent process provided in the record.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 30
France
- Earliest CTIS Part Ii Submission Date
- 06-09-2024
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 553
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- Hopital Saint Antoine
- Department Name
- Oncology
- Contact Person Name
- Romain COHEN
- Contact Person Email
- romain.cohen@aphp.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncology
- Contact Person Name
- Ludovic EVESQUE
- Contact Person Email
- ludovic.evesque@nice.unicancer.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Oncology
- Contact Person Name
- Thibault MAZARD
- Contact Person Email
- thibault.Mazard@icm.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Oncology
- Contact Person Name
- David TOUGERON
- Contact Person Email
- David.TOUGERON@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Oncology
- Contact Person Name
- Anthony TURPIN
- Contact Person Email
- anthony.turpin@chru-lille.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Oncology
- Contact Person Name
- Frédéric THUILLIER
- Contact Person Email
- frederic.thuillier@chu-limoges.fr
- Site Name
- Institut Bergonie
- Department Name
- Oncology
- Contact Person Name
- Lola-Jade PALMIERI
- Contact Person Email
- l.palmieri@bordeaux.unicancer.fr
- Site Name
- Centre De Recherche En Cancerologie De Lyon
- Department Name
- Oncology
- Contact Person Name
- Clélia COUTZAC
- Contact Person Email
- clelia.coutzac@lyon.unicancer.fr
- Site Name
- CHU Besancon
- Department Name
- Oncology
- Contact Person Name
- Angelique VIENOT
- Contact Person Email
- A3vienot@xn--chu-besanon-u9a.fr
Sponsor
Primary sponsor
- Full Name
- Association Gercor
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Nivolumab
- Active Substance
- Nivolumab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Ipilimumab
- Active Substance
- Ipilimumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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