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A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

ConditionAdenocarcinoma, Pancreatic Ductal
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of PDAC

Pancreatic cancer tumor, lymph node, metastasis (TNM) pathological staging values of T1-T3, N0-N2, and M0 per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual

Macroscopically complete (R0 or R1) resection of PDAC

Unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to treatment initiation

Disqualifiers

Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer

Plan for further adjuvant anti-cancer therapy for PDAC (e.g., radiotherapy and/or chemotherapy), not mandated per protocol, to be initiated after completion of mFOLFIRINOX treatment

Absence of spleen; distal pancreatectomy with splenectomy is exclusionary

Preexisting Grade >/=2 neuropathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autogene cevumeran

    Drug

    Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.

  • Atezolizumab

    Drug

    Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.

  • mFOLFIRINOX

    Drug

    mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOXExperimental treatment 3 interventions
Group B: Arm 2: mFOLFIRINOXActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease Free Survival (DFS)

Time frame
From randomization to first recurrence of PDAC or first occurrence of new cancer, as determined by the investigator, or death from any cause (whichever occurs first), up to approximately 6 years

Secondary outcomes

1

DFS Rates at 12, 24, and 36 Months

Time frame
Months 12, 24, 36
2

Overall Survival (OS)

Time frame
From randomization to death from any cause (up to approximately 6 years)
3

OS Rates at 3 and 5 Years

Time frame
Years 3 and 5
4

Percentage of Participants With Adverse Events (AEs)

Time frame
Up to approximately 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov
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