MPS-112, MPS-106, MPS-213, MPS-102, MPS-216, MPS-103, MPS-215, MPS-214, D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA, MPS-200 for Pancreatic ductal adenocarcinoma|Locally advanced or metastatic pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Signed and dated informed consent document, willing and able to comply with protocol requirements\n- Recurrent or advanced disease not amenable to surgery with curative intent (previous resection of primary tumor allowed)\n- 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)\n- 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\n- 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\n- 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)\n- Life expectancy ≥ 3 months\n- 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);\n- Registration in a national health care system (PUMA included)\n- Histologically or cytologically proven PDAC\n- Age ≥ 18 years\n- ECOG Performance Status (PS) 0-1\n- HLA-A2 genotype"}

Exclusion criteria

• {"criterion_text":"- Obstructive jaundice (bilirubin > 1.5 ULN) without adequate biliary drainage\n- Any systemic steroid therapy (> 10 mg daily dose of prednisone or equivalent) for more than seven days one month before inclusion\n- Allograft recipient\n- Active HBV, HCV, or HIV infection\n- 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\n- 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\n- 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\n- Uncontrolled massive pleural effusion or massive ascites\n- 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)\n- Evidence of interstitial lung disease, any active, non-infectious pneumonitis, or known active tuberculosis\n- Active uncontrolled infection, or current unstable or uncompensated respiratory or cardiac conditions, or bleeding\n- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study\n- Live vaccine administration within 30 days prior to the first dose of study treatment\n- 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\n- Known or suspected drug hypersensitivity to OSE2101 vaccine\n- 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\n- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of investigational product\n- Treatment with any investigational medicinal product within 28 days prior to study entry\n- Prior intolerance/severe toxicity with 5FU or irinotecan (including DPD and UGT1A1 deficiency)\n- Pregnancy/lactation\n- Tutelage or guardianship"}

Primary endpoints

• {"endpoint_text":"- Evaluable patients for OS rate at 12 months will be patients alive at 12 months and patients dead within 12 months; patients lost to follow-up before 12 months without confirmation of death will be non-evaluable. The OS is defined according to the DATECAN 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.","definition_or_measurement_approach":"OS defined according to the DATECAN consensus as the time from randomization to death for any reason. Patients lost to follow-up before 12 months without confirmation of death will be non-evaluable. In absence of confirmation of death, survival time censored at date of last clinical assessment."}

Secondary endpoints

• {"endpoint_text":"- PFS by centralized review of CT-scan imaging.","definition_or_measurement_approach":"Progression-free survival assessed by centralized review of CT-scan imaging (RECIST v1.1)."}
• {"endpoint_text":"- All grade and severe (grade 3-5) toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0","definition_or_measurement_approach":"Adverse events graded per NCI CTCAE v5.0; report all-grade and grade 3-5 toxicities."}
• {"endpoint_text":"- Response according to RECIST v1.1 77 (centralized review of CT-scan imaging)","definition_or_measurement_approach":"Objective tumor response assessed per RECIST v1.1 by centralized CT-scan review."}
• {"endpoint_text":"- HRQoL assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire","definition_or_measurement_approach":"Health-related quality of life measured using EORTC QLQ-C30 questionnaire."}
• {"endpoint_text":"- Q-TWiST","definition_or_measurement_approach":"Quality-Adjusted Time Without Symptoms of Disease or Toxicity of Treatment (Q-TWiST) methodology."}
• {"endpoint_text":"- Potential predictive biomarkers (blood and tumor tissue)","definition_or_measurement_approach":"Assessment of potential predictive biomarkers from blood and tumor tissue samples (laboratory and imaging markers as indicated in protocol)."}
• {"endpoint_text":"- Immune-related AEs (imAEs) according to sarcopenia","definition_or_measurement_approach":"Evaluation of immune-related adverse events in relation to sarcopenia status."}

France

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

14-11-2024

Processing Time Days

9

Number Of Sites

34

Number Of Participants

106

Primary sponsor

Full Name

Association Gercor

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France