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

NCT05968326
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
260
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Lead sponsor
Genentech, Inc.
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Start date
2023-10-18
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Number of sites
87
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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.
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Acronym
IMCODE003
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Short title
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2031-01-01
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First posted
2023-08-01
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Registry last updated
2026-09-09
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Primary completion date
2031-01-01
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Start date
2023-10-18
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Participants
260
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Participant count basis
Estimated
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Planned participants
260
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Protocol amendments
3
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Number of sites
87
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Genentech, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05968326
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ClinicalTrials.gov ID
NCT05968326
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Disease Free Survival (DFS)

    Timeframe: 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

  1. DFS Rates at 12, 24, and 36 Months

    Timeframe: Months 12, 24, 36

  2. Overall Survival (OS)

    Timeframe: From randomization to death from any cause (up to approximately 6 years)

  3. OS Rates at 3 and 5 Years

    Timeframe: Years 3 and 5

  4. Percentage of Participants With Adverse Events (AEs)

    Timeframe: Up to approximately 6 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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).
Sources for eligibility
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  • USC Norris Comprehensive Cancer CenterLos Angeles, United States
  • USC Norris Cancer CenterNewport Beach, United States
  • University of California, San Francisco (UCSF)San Francisco, United States
  • University of California Los AngelesSanta Monica, United States
  • St. Francis Hospital and Medical CenterHartford, United States
  • Yale Cancer CenterNew Haven, United States
  • Smilow Cancer Hospital Care Center at TrumbullTrumbull, United States
  • Northwestern Memorial HospitalChicago, United States
  • Indiana University Health Melvin & Bren Simon Cancer CenterIndianapolis, United States
  • University of Kentucky Medical CenterLexington, United States
  • Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer CenterBoston, United States
  • Boston Medical Center (BMC) - Cancer Care CenterBoston, United States
  • Henry Ford Health SystemDetroit, United States
  • University of NebraskaOmaha, United States
  • Memorial Sloan Kettering Cancer Center Basking RidgeBasking Ridge, United States
  • Memorial Sloan Kettering Cancer CenterMiddletown, United States
  • Memorial Sloan Kettering Cancer Center at BergenMontvale, United States
  • Memorial Sloan Kettering Cancer Center - CommackCommack, United States
  • Memorial Sloan Kettering Cancer Center at WestchesterHarrison, United States
  • Northwell HealthLake Success, United States
  • Mount SInai Medical CenterNew York, United States
  • Columbia University Medical CenterNew York, United States
  • MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHHNew York, United States
  • Memorial Sloan Kettering Cancer CenterNew York, United States
  • Memorial Sloan Kettering Cancer Center at NassauUniondale, United States

And 62 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-502404-73-00
Sources for references
clinicaltrials.gov

Related records

Drugs (6)

Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (3)