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

Participants were pregnant or breastfeeding or planning pregnancy or to father children during the study or within 60 days after last IMP treatment

A medical, psychological, or social condition which, in the opinion of the investigator, could have compromised their wellbeing if they participated in the study, or that could have prevented, limited, or confounded the protocol specified assessments or procedures, or that could have impacted adherence to protocol-described requirements

Had major surgery within 3 weeks of first dose of the study treatment, where participation in the study could have compromised the participant's wellbeing in the opinion of the investigator

Had abnormal electrocardiograms (ECGs) that were 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)

Had a history of anaphylactic reaction to human, or humanized, antibody

Have had other known active cancer(s) likely to require treatment in the next 2 years

Had prior radiotherapy or systemic treatment for PDAC

Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic antiinfective therapy that has been administered less than 2 weeks prior to the first dose of BNT321

Known hypersensitivity to any of the excipients of the experimental product BNT321

Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell counts \<350 cells/μL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections

Known history/positive serology for Hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy; participants with positive serology must have had Hepatitis B virus viral load below the limit of quantification)

Active Hepatitis C virus infection (participants who have had completed curative antiviral treatment with Hepatitis C virus viral load below the limit of quantification were allowed)

Use of any IMP or device within 21 days before administration of first dose of study treatment or ongoing participation in the active treatment phase of another interventional clinical study

Was subject to exclusion periods from another investigational study

Were vulnerable individuals as per ICH E6 definition, i.e., individuals whose willingness to participate in a clinical study 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.

Serum CA19-9 \>180 U/mL within 3 weeks of C1D1

Incomplete macroscopic tumor removal (R2 resection)

Significant cardiovascular risk (past medical history of coronary stenting or myocardial infarction within 6 months, or New York Heart Association (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 or family history of long QT syndrome)

Pre-existing neuropathy

Homozygous UDP glucuronosyltransferase family 1 member A1 (UGT1A1)\*28 mutation, if testing was required by local regulations

Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe post-operative uncontrolled diarrhea

Complete dihydropyrimidine dehydrogenase deficiency, if testing was required by local regulations

Received a live vaccine within 3 weeks prior to the first dose of study treatment

Participants with a contraindication to receiving mFOLFIRINOX

Participants 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

What this study is about