Clinical trial • Phase II | Phase IV • Oncology
Relatlimab for Cervical cancer | Cervical squamous cell carcinoma | Cervical adenosquamous carcinoma
Phase II | Phase IV trial of Relatlimab for Cervical cancer | Cervical squamous cell carcinoma | Cervical adenosquamous carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cervical cancer | Cervical squamous cell carcinoma | Cervical adenosquamous carcinoma
- Trial Stage
- Phase II | Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 07-06-2024
- First CTIS Authorization Date
- 24-09-2024
Trial design
Randomised, open-label, relatlimab + nivolumab versus nivolumab alone (dose and schedule not specified)-controlled Phase II | Phase IV trial across 31 sites in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Relatlimab + Nivolumab versus Nivolumab alone (dose and schedule not specified)
- Target Sample Size
- 72
Eligibility
Recruits 72 No vulnerable populations selected (isVulnerablePopulationSelected=false). Trial includes only female subjects; specific consent/assent handling not specified in the record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected=false). Trial includes only female subjects; specific consent/assent handling not specified in the record.
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 66
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 72
France
- Earliest CTIS Part Ii Submission Date
- 13-08-2024
- Latest Decision Or Authorization Date
- 19-09-2025
- Processing Time Days
- 402
- Number Of Sites
- 31
- Number Of Participants
- 72
Sites
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Bertrand BILLEMONT
- Principal Investigator Email
- b.billemont@isc84.org
- Contact Person Name
- Bertrand BILLEMONT
- Contact Person Email
- b.billemont@isc84.org
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Marie Christine KAMINSKY
- Principal Investigator Email
- mc.kaminsky@nancy.unicancer.fr
- Contact Person Name
- Marie Christine KAMINSKY
- Contact Person Email
- mc.kaminsky@nancy.unicancer.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Elise DELUCHE
- Principal Investigator Email
- elise.deluche@chu-limoges.fr
- Contact Person Name
- Elise DELUCHE
- Contact Person Email
- elise.deluche@chu-limoges.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Gilles FREYER
- Principal Investigator Email
- gilles.freyer@univ-lyon1.fr
- Contact Person Name
- Gilles FREYER
- Contact Person Email
- gilles.freyer@univ-lyon1.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Abel CORDOBA
- Principal Investigator Email
- a-cordoba@o-lambret.fr
- Contact Person Name
- Abel CORDOBA
- Contact Person Email
- a-cordoba@o-lambret.fr
- Site Name
- CHU de Besançon
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Laura MANSI
- Principal Investigator Email
- lmansi@chu-besancon.fr
- Contact Person Name
- Laura MANSI
- Contact Person Email
- lmansi@chu-besancon.fr
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Sylvain DEMONTOY
- Principal Investigator Email
- sylvain.demontoy@icm.unicancer.fr
- Contact Person Name
- Sylvain DEMONTOY
- Contact Person Email
- sylvain.demontoy@icm.unicancer.fr
- Site Name
- Institut de Cancérologie de l'Ouest - site de Saint Herblain
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Dominique BERTON
- Principal Investigator Email
- dominique.berton@ico.unicancer.fr
- Contact Person Name
- Dominique BERTON
- Contact Person Email
- dominique.berton@ico.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Isabelle RAY COQUARD
- Principal Investigator Email
- isabelle.ray-coquard@lyon.unicancer.fr
- Contact Person Name
- Isabelle RAY COQUARD
- Contact Person Email
- isabelle.ray-coquard@lyon.unicancer.fr
- Site Name
- Societe De Recherche Oncologique Clinique 37
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Pierre COMBE
- Principal Investigator Email
- p.combe@cort37.fr
- Contact Person Name
- Pierre COMBE
- Contact Person Email
- p.combe@cort37.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Alexandra LEARY
- Principal Investigator Email
- alexandra.leary@gustaveroussy.fr
- Contact Person Name
- Alexandra LEARY
- Contact Person Email
- alexandra.leary@gustaveroussy.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- ONCOLOGY
- 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
- Centre Hospitalier Universitaire De Lille
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Yohan KERBAGE
- Principal Investigator Email
- yohan.kerbage@chu-lille.fr
- Contact Person Name
- Yohan KERBAGE
- Contact Person Email
- yohan.kerbage@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Gilles FREYER
- Principal Investigator Email
- gilles.freyer@chu-st-etienne.fr
- Contact Person Name
- Gilles FREYER
- Contact Person Email
- gilles.freyer@chu-st-etienne.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Renaud SABATIER
- Principal Investigator Email
- sabatierr@ipc.unicancer.fr
- Contact Person Name
- Renaud SABATIER
- Contact Person Email
- sabatierr@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Soumya ANANE-ABROUS
- Principal Investigator Email
- Soumya.Anane@chicreteil.fr
- Contact Person Name
- Soumya ANANE-ABROUS
- Contact Person Email
- Soumya.Anane@chicreteil.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Sarah BETRIAN LAGARDE
- Principal Investigator Email
- betrian.sarah@iuct-oncopole.fr
- Contact Person Name
- Sarah BETRIAN LAGARDE
- Contact Person Email
- betrian.sarah@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Laura DEIANA
- Principal Investigator Email
- laura.deiana@chu-brest.fr
- Contact Person Name
- Laura DEIANA
- Contact Person Email
- laura.deiana@chu-brest.fr
- Site Name
- Institut Bergonié
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Adeline PETIT
- Principal Investigator Email
- A.Petit@bordeaux.unicancer.fr
- Contact Person Name
- Adeline PETIT
- Contact Person Email
- A.Petit@bordeaux.unicancer.fr
- Site Name
- Groupe Hospitalier Diaconesses Croix Saint Simon
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Antoine ANGELERGUES
- Principal Investigator Email
- AAngelergues@hopital-dcss.org
- Contact Person Name
- Antoine ANGELERGUES
- Contact Person Email
- AAngelergues@hopital-dcss.org
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Jean-David FUMET
- Principal Investigator Email
- jdfumet@cgfl.fr
- Contact Person Name
- Jean-David FUMET
- Contact Person Email
- jdfumet@cgfl.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Sheik EMAMBUX
- Principal Investigator Email
- sheik.emambux@chu-poitiers.fr
- Contact Person Name
- Sheik EMAMBUX
- Contact Person Email
- sheik.emambux@chu-poitiers.fr
- Site Name
- CARIO Centre Armoricain de Radiotherapie D'Imagerie medicale et D'Oncologie
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Anne Claire HARDY BESSARD
- Principal Investigator Email
- ac.hardy@cario-sante.fr
- Contact Person Name
- Anne Claire HARDY BESSARD
- Contact Person Email
- ac.hardy@cario-sante.fr
- Site Name
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Thibault DE LA MOTTE ROUGE
- Principal Investigator Email
- t.delamotterouge@rennes.unicancer.fr
- Contact Person Name
- Thibault DE LA MOTTE ROUGE
- Contact Person Email
- t.delamotterouge@rennes.unicancer.fr
- Site Name
- Centre Jean Perrin
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Elsa KALBACHER
- Principal Investigator Email
- Elsa.KALBACHER@clermont.unicancer.fr
- Contact Person Name
- Elsa KALBACHER
- Contact Person Email
- Elsa.KALBACHER@clermont.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Marie CHAIX
- Principal Investigator Email
- marie.chaix@chu-dijon.fr
- Contact Person Name
- Marie CHAIX
- Contact Person Email
- marie.chaix@chu-dijon.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Sofia BAKKAR
- Principal Investigator Email
- s.bakkar@chu-tours.fr
- Contact Person Name
- Sofia BAKKAR
- Contact Person Email
- s.bakkar@chu-tours.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Philippe FOLLANA
- Principal Investigator Email
- philippe.follana@nice.unicancer.fr
- Contact Person Name
- Philippe FOLLANA
- Contact Person Email
- philippe.follana@nice.unicancer.fr
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Lauriane EBERST
- Principal Investigator Email
- l.eberst@icans.eu
- Contact Person Name
- Lauriane EBERST
- Contact Person Email
- l.eberst@icans.eu
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Paule AUGEREAU
- Principal Investigator Email
- paule.augereau@ico.unicancer.fr
- Contact Person Name
- Paule AUGEREAU
- Contact Person Email
- paule.augereau@ico.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- ONCOLOGY
- Principal Investigator Name
- Helene SALAUN
- Principal Investigator Email
- helene.salaun@curie.fr
- Contact Person Name
- Helene SALAUN
- Contact Person Email
- helene.salaun@curie.fr
Sponsor
Primary sponsor
- Full Name
- Asso De Recherche Cancers Gynecologiques
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Relatlimab
- Active Substance
- Relatlimab
- Modality
- Monoclonal antibody
- Investigational Product Name
- Nivolumab
- Active Substance
- Nivolumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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