Etude : NORSE / CR108445



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : NORSE

Nom : CR108445

Traitement : Métastatique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 28/02/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude de phase 1b-2 visant à évaluer la tolérance, l’efficacité, la pharmacocinétique et la pharmacodynamique de l’Erdafitinib combiné à JNJ-63723283 (Cetrelimab), un anticorps monoclonal anti-PD-1, chez des patients présentant un cancer urothélial métastatique ou localement avancé avec des altérations sélectionnées du gène FGFR

Spécialité : Voies urinaires
Localisation : C67 - Tumeur maligne de la vessie
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This open-label (all people know identity of intervention) and multicenter (when more than one hospital or medical school team work on a medical research study) study of erdafitinib plus cetrelimab in participants with advanced urothelial cancer with selected fibroblast growth factor receptor (FGFR) gene alterations, will consists of 2 parts. Participants enrolled in Part 1 may have received any number of lines of prior therapy, and participants enrolled in Part 2 will have had no prior systemic therapy for metastatic disease and cis-ineligible. Part 1 (Phase 1b: Dose Escalation) will establish recommended Phase 2 dose (RP2D) for erdafitinib in combination with cetrelimab, and Part 2 (Phase 2: Dose Expansion) will evaluate safety and efficacy of RP2D. The study will be conducted in 3 phases: screening phase, treatment phase, and follow-up phase. Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers, and safety.

Phase : I/II

Stade : Localement avancé à Métastasique

1, 2, 3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion :
Histologic demonstration of transitional cell carcinoma of the urothelium. Variant urothelial carcinoma histologies such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
Metastatic or locally advanced urothelial cancer
Must have measurable disease by radiological imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
Prior systemic therapy for metastatic urothelial cancer: (a) Phase 1b: Any number of lines of prior therapy; (b) Phase 2: No prior systemic therapy for metastatic disease and cisplatin-ineligible
Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of: 0, 1, or 2

Critères de non-inclusion :
Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to Cycle 1 Day 1. For Phase 1b, participants who have received the following prior antitumor therapy: received nitrosoureas and mitomycin C within 6 weeks
Chemotherapy within 3 weeks of Cycle 1 Day 1
Prior anti-programmed death receptor-1 (PD-1), anti-programmed death ligand-1 (PD-L1), or anti-programmed death ligand-2 (PD-L2) therapy. Prior neoadjuvant/adjuvant checkpoint inhibitor therapy is allowed if the last dose was given more than (>)12 months prior to recurrent disease progression and did not result in drug-related toxicity leading to treatment discontinuation
Active malignancies requiring concurrent therapy other than urothelial cancer
Symptomatic central nervous system metastases
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03473743
Promoteur :
JANSSEN
Type de sponsor : Industriel
JANSSEN - JANSSEN
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Elodie COQUAN

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Statut de l'essai : OUVERT

MAJ : 17/01/2020