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

NCT03806309 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: TEDOPAM D17-01 PRODIGE 63
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 28

Brief Summary

TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX.

Conditions

Pancreatic Ductal Adenocarcinoma; Locally Advanced Cancer; Metastatic Cancer

Keywords

Immunotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  The OS is defined according to the DATECAN (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) consensus as the time from randomization to death for any reason. In the absence of confirmation of death, survival time will be censored at the date of the last clinical assessment

  At 12 months

Secondary Outcomes (6)

• Progression free survival (PFS) by centralized review of CT-scan imaging.

  assessed up to 60 months

• Rate of patients with success of the strategy (SSR)

  At 6 months

• Number of participants with treatment-related adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCICTCAE] v5.0

  from signature of informed consent to 28 days after the last administration of the investigational product in Arm A and B and 100 days after the last administration of the investigational product in Arm C.

• Objective response rate (ORR)

  assessed up to 60 months

• Health-related Quality of life (HRQoL) evaluation assessed by EORTC QLQ (quality of life questionnaire) -C30 questionnaire

  Baseline, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12, Month 14, Month 16, Month 18, Month 20, Month 22, Month 24 (until the date of first documented progression or date of death, assessed up 60 months)

Study Arms (2)

Arm A : maintenance with FOLFIRI

ACTIVE COMPARATOR

FOLFIRI (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\^2/46h (dose adjustment will be accepted).

Drug: FOLFIRI

Arm B : maintenance with OSE2101 plus FOLFIRI

EXPERIMENTAL

OSE2101 - subcutaneous injection on day 1 and day 15, every 4 weeks for 6 doses then every 8 weeks until month 12 then every 12 weeks up to 24 months. FOLFIRI - schedules as in Arm A until disease progression on unacceptable toxicity

Drug: FOLFIRI; Drug: OSE2101

Interventions

FOLFIRI DRUG

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

Also known as: Leucovorin (Folinic Acid), Fluorouracil, Irinotecan

Arm A : maintenance with FOLFIRI; Arm B : maintenance with OSE2101 plus FOLFIRI

OSE2101 DRUG

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

Also known as: Tedopi

Arm B : maintenance with OSE2101 plus FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent document, willing and able to comply with protocol requirements,
• Histologically or cytologically proven pancreatic ductal adenocarcinoma,
• Age ≥ 18 years,
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1,
• Human Leukocyte Antigen (HLA-A2) genotype,
• Recurrent or advanced disease not amenable to surgery with curative intent (previous resection of primary tumor allowed),
• Measurable or evaluable (radiologically detectable disease which does not fulfill RECIST criteria for measurable disease) lesions according to RECIST v1.1 criteria (CT-scan \< 4 weeks),
• Stable disease or tumor response according to RECIST v1.1 after a 4-month (8 cycles) course of first-line FOLFIRINOX or modified FOLFIRINOX induction chemotherapy,
• Have archival tissue sample that has been identified and confirmed as available for study, or newly obtained core or excisional biopsy of a tumor lesion,
• Adequate organ function, as defined by the following:
• Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) \< 3 x upper limit of normal (ULN),
• Total serum bilirubin \< 1.5 ULN,
• Prothrombin ratio \> 70%,
• Serum albumin ≥ 2.8 g/dL,
• Hemoglobin ≥ 10,0 g/dl,

You may not qualify if:

• Obstructive jaundice (bilirubin \> 1.5 ULN) without adequate biliary drainage,
• Allograft recipient,
• Active HBV (hepatitis B virus), HCV (hepatitis C virus ), or HIV infection, Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive HBc (hepatitis B core antigen) antibody test are eligible.
• Note: Patients positive for HCV antibody are eligible only if polymerase chain reaction testing is negative for HCV ribonucleic acid (RNA).
• Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri,
• Known active central nervous system metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurological symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids at a dose \> 10 mg/day of prednisone or equivalent for at least 14 days prior to trial treatment,
• Uncontrolled massive pleural effusion or massive ascites,
• Evidence of interstitial lung disease, any active, non-infectious pneumonitis, or known active tuberculosis,
• Active uncontrolled infection, or current unstable or uncompensated respiratory or cardiac conditions, or bleeding,
• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study,
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant, in the opinion of the treating investigator,
• Known or suspected drug hypersensitivity to OSE2101 vaccine,
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug,
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product, Note: Local surgery of isolated lesions for palliative intent is acceptable.
• Treatment with any investigational medicinal product within 28 days prior to study entry,

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead
• OSE Immunotherapeutics: collaborator

Study Sites (28)

Clinique de l'Europe

Amiens, France

Location

Hôpital Sud CHU Amiens

Amiens, France

Location

CH Beauvais

Beauvais, France

Location

CHRU Jean Minjoz

Besançon, France

Location

Clinique Tivoli Ducos

Bordeaux, France

Location

CHU Morvan

Brest, France

Location

GHPSO Site de Creil

Creil, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Centre Georges François Leclerc

Dijon, France

Location

CHU Dijon

Dijon, France

Location

CHRU Lille

Lille, France

Location

centre Léon Bérard

Lyon, France

Location

Hôpital Edouard Herriot

Lyon, France

Location

Hôpital la Croix Rousse

Lyon, France

Location

Hôpital Lyon Sud Hospices Civils de Lyon

Lyon, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

Hôpital Européen

Marseille, France

Location

Institut Paoli Calmette

Marseille, France

Location

Hôpital Pitié Salpêtrière

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Robert Debré

Reims, France

Location

Institut Curie

Saint-Cloud, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Clinique Pasteur

Toulouse, France

Location

Hôpital TROUSSEAU

Tours, France

Location

Insitut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

IFL protocol; Leucovorin; Fluorouracil; Irinotecan

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Officials

• Cindy NEUZILLET, MD

  Institut Curie site de Saint Cloud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2018
• First Posted: January 16, 2019
• Study Start: April 10, 2021
• Primary Completion: December 9, 2024
• Study Completion: December 1, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (28)