OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

April 10, 2021

Primary Completion Date

December 9, 2024

Study Completion Date

December 31, 2025

Conditions
Pancreatic Ductal AdenocarcinomaLocally Advanced CancerMetastatic Cancer
Interventions
DRUG

FOLFIRI

Intravenous (IV); folinic acid 400 mg/m\^2, irinotecan 180 mg/m\^2, 5-FU bolus 400 mg/m\^2 and continuous infusion 2,400 mg/m\^2

DRUG

OSE2101

subcutaneous injection on days 1 and 15, every 4 weeks for 6 doses then every 8 weeks until month 12 and then every 12 weeks for a maximum treatment duration of 24 months

Trial Locations (28)

Unknown

Clinique de l'Europe, Amiens

Hôpital Sud CHU Amiens, Amiens

CH Beauvais, Beauvais

CHRU Jean Minjoz, Besançon

Clinique Tivoli Ducos, Bordeaux

CHU Morvan, Brest

GHPSO Site de Creil, Creil

Hôpital Henri Mondor, Créteil

Centre Georges François Leclerc, Dijon

CHU Dijon, Dijon

CHRU Lille, Lille

centre Léon Bérard, Lyon

Hôpital Edouard Herriot, Lyon

Hôpital la Croix Rousse, Lyon

Hôpital Lyon Sud Hospices Civils de Lyon, Lyon

Hôpital Privé Jean Mermoz, Lyon

Hôpital Européen, Marseille

Institut Paoli Calmette, Marseille

Hôpital Pitié Salpêtrière, Paris

Hôpital Saint Antoine, Paris

Institut Mutualiste Montsouris, Paris

CHU Poitiers, Poitiers

CHU Robert Debré, Reims

Institut Curie, Saint-Cloud

Centre Paul Strauss, Strasbourg

Clinique Pasteur, Toulouse

Hôpital TROUSSEAU, Tours

Insitut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

OSE Immunotherapeutics

INDUSTRY

lead

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

NCT03806309 - OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC | Biotech Hunter | Biotech Hunter