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NCT Number: NCT05968326

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Antwerp University Hospital, Edegem, VAN, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 treatment initiation
  • 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. They must refrain from donating eggs for 9 months after the last dose of chemotherapy.
  • 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 cytochrome P450 3A4 (CYP3A4) and/or uridine diphosphate glucoronosyltransferase 1A1 (UGT1A1).

Treatment and study plan

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.

Other names: Tecentriq

mFOLFIRINOX

Drug

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: GO44479 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • BioNTech SE

Registry information

Official study 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

Acronym: IMCODE003

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Aug 1, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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