2 Participants Needed

mFOLFIRINOX + BNT321 for Pancreatic Cancer

Recruiting at 3 trial locations
Bc
Overseen ByBioNTech clinical trials patient information
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: BioNTech SE
Must be taking: mFOLFIRINOX
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Yes, mFOLFIRINOX is a promising drug for pancreatic cancer. It is a modified version of a chemotherapy regimen that has shown to be effective and better tolerated, leading to improved survival rates in patients with advanced pancreatic cancer.12346

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

BR

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

Has signed an informed consent form (ICF) before initiation of any trial-specific procedures
My pancreatic cancer diagnosis was confirmed through lab tests.
Your lab test results are normal.
See 10 more

Exclusion Criteria

You have had a severe allergic reaction to a specific type of antibody.
Your blood test showed high levels of CA19-9 within 3 weeks before the start of the trial.
My surgery did not remove all of my tumor.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Dose escalation of BNT321 in combination with mFOLFIRINOX chemotherapy

24 weeks
Bi-weekly visits for treatment cycles

Phase I BNT321 Monotherapy

BNT321 monotherapy following combination treatment

24 weeks
Bi-weekly visits for treatment cycles

Phase II Treatment

Randomized treatment with mFOLFIRINOX ± BNT321

24 weeks
Bi-weekly visits for treatment cycles

Phase II BNT321 Monotherapy

BNT321 monotherapy in the combination arm

24 weeks
Bi-weekly visits for treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 60 months

Treatment Details

Interventions

  • BNT321 Dose Level 1
  • BNT321 Dose Level 2
  • BNT321 RP2D
  • mFOLFIRINOX
Trial Overview The study tests the safety and effectiveness of mFOLFIRINOX alone or combined with varying doses of BNT321 as post-surgery therapy for pancreatic cancer. It's in two parts: first determining safe dosage levels (Phase I), then comparing treatments (Phase II) over 48 weeks with cycles every two weeks.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 - BNT321 RP2D + mFOLFIRINOXExperimental Treatment2 Interventions
BNT321 in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks)
Group II: Phase 1 - BNT321 Dose Level 2 + mFOLFIRINOXExperimental Treatment2 Interventions
BNT321 in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks)
Group III: Phase 1 - BNT321 Dose Level 1 + mFOLFIRINOXExperimental Treatment2 Interventions
BNT321 in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks)
Group IV: Phase 2 - mFOLFIRINOXActive Control1 Intervention
mFOLFIRINOX chemotherapy (24 weeks) as monotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials
84
Recruited
120,000+

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

Findings from Research

Modified-dose FOLFIRINOX (mFOLFIRINOX) demonstrated comparable efficacy to standard-dose FOLFIRINOX (sFOLFIRINOX) in treating pancreatic cancer, with similar objective response rates and overall survival outcomes among 130 patients studied.
mFOLFIRINOX was associated with significantly lower rates of severe adverse events, such as neutropenia, anorexia, and diarrhea, suggesting it is a safer option for patients who may be concerned about toxicity while maintaining effective treatment.
Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer.Kang, H., Jo, JH., Lee, HS., et al.[2022]
In a study of 15 patients with advanced biliary tract cancer who had not responded to previous chemotherapy, the modified FOLFIRINOX (mFOLFIRINOX) regimen showed promising efficacy, with a 26.7% objective response rate and an 80% disease control rate.
The treatment was well-tolerated, with a median overall survival of 13.2 months and manageable side effects, primarily grade 3/4 neutropenia, indicating that mFOLFIRINOX could be a viable salvage therapy option for these patients.
Efficacy and safety of modified FOLFIRINOX as salvage therapy for patients with refractory advanced biliary tract cancer: a retrospective study.Ye, LF., Ren, C., Bai, L., et al.[2022]
The modified FOLFIRINOX (mFOLFIRINOX) regimen demonstrated a high treatment efficacy in patients with locally advanced pancreatic cancer (LAPC) and metastatic pancreatic cancer (MPC), achieving a response rate of 55.2% among 29 evaluable patients.
The treatment was well-tolerated, with only 9 patients experiencing grade 3 or 4 adverse effects, and no patients discontinued treatment due to side effects, indicating a favorable safety profile for this regimen.
[Modified FOLFIRINOX for advanced pancreatic cancer: a tertiary center experience from China].Bai, X., Su, R., Ma, T., et al.[2018]

References

Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer. [2022]
Efficacy and safety of modified FOLFIRINOX as salvage therapy for patients with refractory advanced biliary tract cancer: a retrospective study. [2022]
[Modified FOLFIRINOX for advanced pancreatic cancer: a tertiary center experience from China]. [2018]
Efficacy and safety of SOXIRI versus mFOLFIRINOX in advanced pancreatic cancer. [2023]
The benefits of modified FOLFIRINOX for advanced pancreatic cancer and its induced adverse events: a systematic review and meta-analysis. [2022]
[The Treatment Outcomes of FOLFIRINOX for Unresectable and Recurrent Pancreatic Cancer]. [2018]
A Single-Center Retrospective Study to Compare the Efficacy and Safety of Modified FOLFIRINOX with S-1 as Adjuvant Chemotherapy in 71 Patients with Resected Pancreatic Carcinoma. [2023]
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