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 (IMCODE003)

• ClinicalTrials.gov Identifier: NCT05968326
• Recruitment Status: Recruiting
• First Posted: August 1, 2023
• Last Update Posted: April 26, 2024
• Sponsor: Genentech, Inc.
• Collaborator: BioNTech SE
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: July 21, 2023
• First Posted Date: August 1, 2023
• Last Update Posted Date: April 26, 2024
• Actual Study Start Date: October 18, 2023
• Estimated Primary Completion Date: December 27, 2029 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 21, 2023): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 21, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Adenocarcinoma, Pancreatic Ductal

Intervention

• Drug: Autogene cevumeran
  Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
• Drug: Atezolizumab
  Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
  Other Name: Tecentriq
• Drug: mFOLFIRINOX
  mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.

Study Arms

• Experimental: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
  Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
  Interventions:

  • Drug: Autogene cevumeran
  • Drug: Atezolizumab
  • Drug: mFOLFIRINOX
• Active Comparator: Arm 2: mFOLFIRINOX
  Participants will receive mFOLFIRINOX.
  Intervention: Drug: mFOLFIRINOX

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 21, 2023): 260
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 27, 2029
• Estimated Primary Completion Date: December 27, 2029 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 initiation of study treatment
• 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 28 days after the final dose of autogene cevumeran, for 9 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
• 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
• Known complete dihydropyrimidine dehydrogenase (DPD) deficiency including homozygous or compound heterozygous mutations of DPYD genetic locus associated with DPD deficiency
• Disorders of the colon or rectum, or postoperative complication leading to Grade >/=2 diarrhea
• Pregnancy or breastfeeding
• Active or history of autoimmune disease or immune deficiency
• Treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of DPD, within 4 weeks prior to initiation of study treatment
• Current or planned treatment with strong inhibitors or inducers of CYP3A4 and/or UGT1A1.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Reference Study ID Number: GO44479 https://forpatients.roche.com/; 888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05968326
• Other Study ID Numbers: GO44479; 2022-502404-73-00 ( Registry Identifier: EU CT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: BioNTech SE

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Genentech, Inc.
• Verification Date: April 2024