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Pancreatic Ductal AdenocarcinomaPhase 2TEDOPAMNCT03806309

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

A Phase 2 study testing FOLFIRI and OSE2101 in people with Pancreatic Ductal Adenocarcinoma and Locally Advanced Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 28 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FOLFIRI and OSE2101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
28 sitesFrance
Study dates
10 Apr 2021to Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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),
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  • 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,
  • White blood cell count (WBC) ≥ 3,000/μL,
  • Absolute neutrophil count (ANC) ≥ 1,500/μL,
  • Platelets ≥ 100,000/μL,
  • Serum creatinine ≤ 1.5 ULN or creatinine clearance > 50 mL/min (Modification of diet in renal disease [MDRD]),
  • Life expectancy ≥ 3 months,
  • Women participants of childbearing potential must have a negative serum pregnancy test within the 3 days prior to the first treatment administration. Both women participants of childbearing potential and men participants who are sexually active with women of childbearing potential must agree to use a reliable method of birth control (i.e. pregnancy rate < 1% per year) until 6 months after the last dose of FOLFIRI, and 90 days after the last dose of OSE2101,
  • Registration in a national health care system (PUMA included).

Who cannot join

  • 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,
  • Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of neuropathy, alopecia, and the laboratory values defined in the inclusion criteria,
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  • 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,
  • Prior intolerance/severe toxicity with 5-fluorouracil (5-FU) or irinotecan (including dihydropyrimidinedehydrogenase [DPD] and UGT1A1 deficiency),
  • Pregnancy/lactation,
  • Tutelage or guardianship.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • 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

Other trials in France

About this study

Official title: A Randomized Non-comparative Phase II Study of Maintenance Therapy With OSE2101 Plus FOLFIRI, or FOLFIRI After Induction Therapy With FOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (TEDOPaM-D17-01 PRODIGE 63 Study)

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.

Read the detailed description

Current standard of care for patients with advanced pancreatic ductal adenocarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5FU, leucovorin, irinotecan, and oxaliplatin) in fit patients (PS 0-1, bilirubin < 1.5 ULN). The question of how and when the FOLFIRINOX regimen and doses can be deescalated after a period of disease control (i.e. maintenance therapy) remains unanswered. In routine practice, oxaliplatin is usually stopped after 6-8 cycles due to limiting neuropathy, and the fluoropyrimidine is continued, either alone or, more frequently, in combination with irinotecan (FOLFIRI regimen), until disease progression.

Immune therapies have opened new opportunities in cancer therapy. However, results of immunotherapy in PDAC have been disappointing so far, with failure of checkpoint inhibitor monotherapies (anti-CTLA4 and anti-PD-L1 monoclonal antibodies [mAb]) in progressive advanced PDAC, while monovalent vaccines were demonstrated to be safe but with limited activity.

Being tested
FOLFIRI, OSE2101
Keywords
Immunotherapy, Chemotherapy
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFIRIDrug

    Also called Leucovorin (Folinic Acid), Fluorouracil, Irinotecan

    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

  • OSE2101Drug

    Also called Tedopi

    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

Study groups in NCT03806309
Study groupRoleWhat they receive
Arm A : maintenance with FOLFIRIActive comparatorFOLFIRI (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).
Receives: Drug: FOLFIRI
Arm B : maintenance with OSE2101 plus FOLFIRIExperimentalOSE2101 - 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
Receives: Drug: FOLFIRI; Drug: OSE2101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 12 months

Secondary outcomes (6)

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

    The PFS is defined according to the DATECAN consensus as the time from randomization to first progression or death for any reason, whichever occurs first. In the absence of event (confirmation of progression or death), PFS status will be censored at the date of the last radiological assessment.

    PFS according to RECIST (Response Evaluation Criteria In Solid Tumors) v1.1 in the FOLFIRI arm (Arm A) and iRECIST (immune Response Evaluation Criteria In Solid Tumors) in the immune therapy arms (Arm B and C) by centralized review of CT-scan imaging

    Measured: assessed up to 60 months

  2. Rate of patients with success of the strategy (SSR)

    The SSR is derived from the duration of disease control (DDC), which is defined as the PFS, or, if FOLFIRI is reintroduced and achieves partial response (PR) or stable disease (SD), as the addition of the initial PFS (PFS1) and the PFS of the reintroduction PFS (PFS2)

    Measured: At 6 months

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

    All grade and severe (grade 3-5) toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: 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.

  4. Objective response rate (ORR)

    Response according to RECIST v1.1 in the FOLFIRI arm (Arm A) and iRECIST in the immune therapy arms (Arms B and C) (centralized review of CT-scan imaging); a comparative analysis of tumor response according to these two evaluation rules will be performed in Arm B and C

    Measured: assessed up to 60 months

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

    Rate of patients with an improvement of their quality of life score according to EORTC QLQ-C30. A quality of life score is obtained according to the answers to the 30 questions. The Minimal Clinically Important Difference (MCID) will be fixed to 10 points.

    Measured: 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)

  6. Estimate the Quality-Adjusted Time Without Symptoms of Disease or Toxicity of Treatment (Q-Twist) for each participant

    Q-TWiST analysis considers three health states, TOX (toxicity), TWiST, and REL (The duration of the relapse), and the duration of each state is calculated for every patient.

    The TOX state comprises the total number of days after randomisation and before strategy failure spent with toxicity, regardless of when the toxicity started or whether there were gaps between toxicities. All grade 3 or 4 toxicities attributable to the study drugs are included in the analysis, apart from those starting after strategy failure.

    The TWiST state is defined as DDC time minus time with toxicities.

    The duration of the relapse or REL state is defined as OS time minus DDC time, or the period of time from progression to death. Patients alive at the end of the study are censored for the OS endpoint.

    Measured: assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2019
  2. Study start10 Apr 2021
  3. Primary completion9 Dec 2024
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03806309
Sponsor's protocol ID
TEDOPAM D17-01 PRODIGE 63
Acronym
TEDOPAM
Status last verified
Jul 2025
First submitted
24 Nov 2018
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRI and OSE2101 in people with Pancreatic Ductal Adenocarcinoma and Locally Advanced Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03806309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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