mFOLFIRINOX + BNT321 for Pancreatic Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you should discuss your current medications with the trial investigators to ensure they don't interfere with the trial treatments.
What data supports the idea that mFOLFIRINOX + BNT321 for Pancreatic Cancer is an effective treatment?
The available research shows that modified FOLFIRINOX (mFOLFIRINOX) is effective for treating advanced pancreatic cancer. In a study, the 6-month and 1-year survival rates for patients with locally advanced pancreatic cancer were 90.9% and 76.2%, respectively. For metastatic pancreatic cancer, the rates were 79.7% and 47.6%. Additionally, the treatment had a disease control rate of 76.7%, meaning most patients experienced some benefit. Compared to the standard dose, mFOLFIRINOX has fewer side effects, making it a more tolerable option for patients.12345
What safety data is available for mFOLFIRINOX and BNT321 in treating pancreatic cancer?
The safety data for mFOLFIRINOX shows that it is a modified version of the standard FOLFIRINOX regimen, designed to reduce toxicity while maintaining efficacy. Studies indicate that mFOLFIRINOX is generally better tolerated than the standard regimen, with common adverse events including neutropenia, thrombocytopenia, fatigue, nausea, vomiting, and diarrhea. Grade 3/4 adverse events are reported, but no chemotherapy-induced deaths were documented. The safety of BNT321 in combination with mFOLFIRINOX specifically is not detailed in the provided studies, suggesting that further research may be needed to fully understand the safety profile of this combination treatment.12367
Is mFOLFIRINOX + BNT321 a promising drug for pancreatic cancer?
What is the purpose of this trial?
This trial is designed as a Phase I/randomized Phase II open-label trial of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection.The Phase I, dose escalation part of this trial will be a limited evaluation of two planned BNT321 dose levels in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks). Following determination of the combination recommended Phase II dose (RP2D), the Phase II (randomized treatment) part of this trial will be initiated as an open-label 2-arm evaluation of mFOLFIRINOX ± BNT321 (24 weeks) followed by BNT321 monotherapy (24 weeks) in the combination arm only to complete the adjuvant therapy course. Treatment cycles are every 2 weeks (14 days).
Research Team
BioNTech Responsible Person
Principal Investigator
BioNTech SE
Eligibility Criteria
Adults with confirmed pancreatic ductal adenocarcinoma who've had a complete tumor removal surgery can join this trial. They must have no metastatic disease, be fully recovered from surgery to start chemotherapy, and agree to use effective contraception. Exclusions include pregnancy, major recent surgery, significant heart risks, certain infections or allergies, other active cancers needing treatment soon.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose escalation of BNT321 in combination with mFOLFIRINOX chemotherapy
Phase I BNT321 Monotherapy
BNT321 monotherapy following combination treatment
Phase II Treatment
Randomized treatment with mFOLFIRINOX ± BNT321
Phase II BNT321 Monotherapy
BNT321 monotherapy in the combination arm
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BNT321 Dose Level 1
- BNT321 Dose Level 2
- BNT321 RP2D
- mFOLFIRINOX
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University