← Back to Search

mFOLFIRINOX + BNT321 for Pancreatic Cancer

Phase 1 & 2

Recruiting

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically or cytologically confirmed PDAC

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

Study Summary

This trial tests a modified chemotherapy + BNT321 combo to treat pancreatic cancer after surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to BNT321 or typical chemotherapy-related issues like nausea, fatigue, blood cell count changes leading to increased infection risk, nerve damage symptoms such as tingling or numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My pancreatic cancer diagnosis was confirmed through lab tests.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I have fully recovered from surgery and can start chemotherapy.

Select...

I had surgery to remove my cancer completely between 3 and 12 weeks ago and can provide a tissue sample.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1 - The proportion (%) of patients with at least one dose of IMP reporting occurrence of dose limiting toxicities (DLTs)

Phase 1 - The proportion (%) of patients with at least one dose of investigational medicinal product (IMP) reporting treatment emergent adverse events (TEAEs)

Phase 2 - Disease-free survival (DFS)

Secondary outcome measures

Phase 1 and 2 - Change from baseline for patient-reported HRQoL using EORTC Quality of Life Questionnaire for pancreatic cancer (QLQ-Pan26) questionnaires

Phase 1 and 2 - Change from baseline for patient-reported health-related quality of life (HRQoL) using the European organisation for research and treatment of cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30)

Phase 1 and 2 - Change from baseline in combined item scores from EORTC QLQ-C30

+11 more

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mFOLFIRINOX

2013

Completed Phase 2

~40

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor

64 Previous Clinical Trials

107,398 Total Patients Enrolled

BioNTech Responsible PersonStudy DirectorBioNTech SE

33 Previous Clinical Trials

9,484 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this clinical research?

"Affirmative. According to clinicaltrials.gov, this medical trial has been open for recruitment since November 1st 2023 and is still actively seeking participants at a single site. It anticipates enrolling 300 individuals in total."

Answered by AI

Are there currently any openings for participation in this medical experiment?

"Affirmative. The details listed on clinicaltrials.gov demonstrate that this experiment, initially posted November 1st 2023, is in the process of recruiting participants. 300 people need to be enrolled from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

2024. "Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06069778.