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Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (TEDOPAM)
EU CTIS ID: 2024-518139-12-00
What this study is testing
To assess the overall survival (OS) of OSE2101 plus FOLFIRI or FOLFIRI alone as maintenance therapy in patients with locally advanced or metastatic PDAC, HLA-A2 positive, having experienced 4-month induction chemotherapy with FOLFIRINOX without disease progression
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent document, willing and able to comply with protocol requirements
- 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, CT-scan at C8 ± 2 weeks) 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 (MDRD)
You likely can't join if
- Obstructive jaundice (bilirubin > 1.5 ULN) without adequate biliary drainage
- 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
- Live vaccine administration within 30 days prior to the first dose of study treatment
- 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
See the full eligibility criteria
Who can join
- Signed and dated informed consent document, willing and able to comply with protocol requirements
- 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, CT-scan at C8 ± 2 weeks) 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 (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 until 180 days after the last dose of FOLFIRI, and after the last dose of OSE2101 for women and 90 days after the last dose of OSE2101 for men. 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);
- Registration in a national health care system (PUMA included)
- Histologically or cytologically proven PDAC
- Age ≥ 18 years
- ECOG Performance Status (PS) 0-1
- HLA-A2 genotype
What rules you out
- Obstructive jaundice (bilirubin > 1.5 ULN) without adequate biliary drainage
- 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
- Live vaccine administration within 30 days prior to the first dose of study treatment
- 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
- Treatment with any investigational medicinal product within 28 days prior to study entry
- Prior intolerance/severe toxicity with 5FU or irinotecan (including DPD and UGT1A1 deficiency)
- Any systemic steroid therapy (> 10 mg daily dose of prednisone or equivalent) for more than seven days one month before inclusion
- Pregnancy/lactation
- Tutelage or guardianship
- Allograft recipient
- Active HBV, HCV, or HIV infection
- 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
- 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 neurologic 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
- History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, that has required systemic treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.