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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma

Conditions
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Adenocarcinoma, Pancreatic Ductal

Intervention / Treatment
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* Drug: Autogene cevumeran
* Drug: Atezolizumab
* Drug: mFOLFIRINOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 randomization CA19-9 level measured within 14 days prior to randomization Interval of between 6 and 12 weeks since resection of PDAC Full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mFOLFIRINOX in the investigator's judgment Adequate hematologic and end-organ function Female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 90 days after the final dose of autogene cevumeran, for 6 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab. Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. Men must refrain from donating sperm during this same period. Exclusion Criteria: Prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer Absence of spleen; distal pancreatectomy with splenectomy is exclusionary Pregnancy or breastfeeding Active or history of autoimmune disease or immune deficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX<br>Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX. | Drug: Autogene cevumeran<br>* Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.<br>Drug: Atezolizumab<br>* Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.<br>* Other names: Tecentriq;Drug: mFOLFIRINOX<br>* mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.<br>|
| Active Comparator: Arm 2: mFOLFIRINOX<br>Participants will receive mFOLFIRINOX. | Drug: mFOLFIRINOX<br>* mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival (DFS) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS Rates at 12, 24, and 36 Months |  | Months 12, 24, 36 | 
| Overall Survival (OS) |  | From randomization to death from any cause (up to approximately 6 years) | 
| OS Rates at 3 and 5 Years |  | Years 3 and 5 | 
| Percentage of Participants With Adverse Events (AEs) |  | Up to approximately 6 years |