Safety, tolerability, and efficacy of mFOLFIRINOX ±BNT321 as adjuvant therapy following curative resection in patients with pancreatic adenocarcinoma
- Conditions
- Resected (R0 or R1) pancreatic ductal adenocarcinomaMedDRA version: 21.0Level: LLTClassification code: 10033602Term: Pancreatic adenocarcinoma resectable Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10051971Term: Pancreatic adenocarcinoma Class: 10029104Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506014-47-00
- Lead Sponsor
- BioNTech SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
Has signed the informed consent form (ICF) before initiation of any trial-specific procedures., Willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the trial., Has an ECOG performance status of 0 to 1., Men who are sexually active with a POCBP and have not had a bilateral vasectomy or orchidectomy must agree to use condoms with a spermicidal agent and to require their female partners to practice a highly effective form of contraception during the trial, starting after signing of the ICF and continuously until 111 days after receiving the last dose of BNT321 and for 6 months after the last oxaliplatin dose., Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)., Had macroscopically complete resection (R0 or R1 resection) performed between =21 and =84 days prior to first trial medication (C1D1). Submission of tumor tissue from resection or biopsy is required., Has no radiologic (CT/MRI) evidence of metastatic disease, malignant ascites, or pleural effusion through an assessment obtained within 4 weeks of first trial medication (i.e., C1D1)., Men who are willing to refrain from sperm donation, starting after signing of ICF and continuously until 111 days (one sperm cycle) after receiving the last dose of BNT321 and for 6 months after the last oxaliplatin dose., POCBP who agree to practice a highly effective form of contraception (for guidance on highly effective forms of contraception, see Section 10.5) and to require their male partners to use condoms with a spermicidal agent, starting after signing of the ICF and continuously throughout trial and for a period of 111 days after the last dose of BNT321 and for 9 months after the last oxaliplatin dose. If the highly effective method of contraception is medically contraindicated, then only the use of condoms with a spermicidal agent is acceptable (Section 4.2.3)., Full recovery from surgery and able to receive chemotherapy., Has acceptable laboratory parameters including: a) absolute neutrophil count (ANC) =1.5x 10E9/L, b) hemoglobin =10.0 g/dL, c) platelet count >100,000/mm10E3, d) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.0x upper limit of normal range (ULN), e) total bilirubin =ULN, f) serum creatinine =1.5x ULN or estimated glomerular filtration rate (eGFR) >50 mL/min, g) serum albumin >3.0 g/dL, Patient of childbearing potential (POCBP) must have a negative urine beta human chorionic gonadotropin (ßhCG) test at screening. Patients that are postmenopausal or permanently sterilized (verified by medical records; for definitions, see Section 10.5) will not be considered POCBP, and therefore are not required to undergo pregnancy testing., Is willing to allow collection of pharmacokinetic samples., POCBP who agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after signing of the ICF and continuously throughout trial and for a period of 3 months after the last dose of BNT321 and for 9 months after the last oxaliplatin dose., Agrees not to enroll in another trial of an investigational medicinal product (IMP), starting after signing of the informed consent form (ICF) and continuously until the last planned visit in this trial., Is >18 years of age or is deemed to be an adult per local authorities at the time of giving written informed consent.
Is pregnant or breastfeeding or is planning a pregnancy or to father children during the trial or within 60 days after last treatment with the investigational medicinal product (IMP)., Had major surgery within 3 weeks of first dose of the trial treatment, where participation in the trial could compromise the patient’s wellbeing in the opinion of the investigator., Has abnormal electrocardiograms (ECGs) that are clinically significant, such as Fridericia-corrected QT prolongation >470 msec (for women) and >450 msec (for men), (average of three ECGs at least 5 minutes apart)., Has a history of anaphylactic reactions to human or humanized antibodies., Has serum CA19-9 >180 U/mL within 3 weeks of first treatment with trial medication (C1D1)., Incomplete macroscopic tumor removal (R2 resection)., Complete dihydropyrimidine dehydrogenase (DPD) deficiency, if testing required by local regulations., Have other known active cancer(s) likely to require treatment in the next 2 years., Had prior radiotherapy or systemic treatment for pancreatic ductal adenocarcinoma (PDAC)., Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic anti-infective therapy that has been administered less than 2 weeks prior to the first dose of BNT321., Is subject to exclusion periods from another investigational trial., Significant cardiovascular risk (past medical history of coronary stenting or myocardial infarction within 6 months, or NYHA Class III/IV, heart failure, or concurrent unstable angina) or risk factors for QT prolongation (sustained Grade 3 or higher hypokalemia, history of unstable arrhythmia, family history of long QT syndrome)., Is a vulnerable individual as per ICH E6 definition, i.e., individuals whose willingness to participate in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate., Known hypersensitivity to any of the excipients of the experimental product BNT321., Has a history/positive serology for Hepatitis B requiring active antiviral therapy., Received a live vaccine within 3 weeks prior to the first dose of trial treatment., Patients with a contraindication to receiving mFOLFIRINOX., Patients with active or latent tuberculosis or history of Mycobacterium tuberculosis infection currently or within the last 2 years., Individuals committed to an institution by virtue of an order issued either by the judicial or the administrative authorities., Has pre-existing neuropathy., Active Hepatitis C virus infection (patients who have completed curative antiviral treatment with Hepatitis C virus viral load below the limit of quantification are allowed)., Homozygous UGT1A1*28 mutation, if testing required by local regulations., Has inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe post-operative uncontrolled diarrhea., Has used any investigational medicinal product (IMP) or device within 21 days before administration of first dose of trial treatment or ongoing participation in the active treatment phase of another interventional clinical trial., Has a history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell counts <350 cells/µL and a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections., Has a medical, psychological, or social condition which
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method