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IMCODE003: 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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05968326
Collaborator
BioNTech SE (Industry)
260
Enrollment
1
Location
2
Arms
70
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 22, 2023
Anticipated Primary Completion Date :
May 22, 2029
Anticipated Study Completion Date :
May 22, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX

Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

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 Names:
  • Tecentriq

    • Drug: mFOLFIRINOX
    mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
    Active Comparator: Arm 2: mFOLFIRINOX

    Participants will receive mFOLFIRINOX.

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

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

    2. Overall Survival (OS) [From randomization to death from any cause (up to approximately 6 years)]

    3. OS Rates at 3 and 5 Years [Years 3 and 5]

    4. Percentage of Participants With Adverse Events (AEs) [Up to approximately 6 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 11101

    Sponsors and Collaborators

    • Genentech, Inc.
    • BioNTech SE

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT05968326
    Other Study ID Numbers:
    • GO44479
    • 2022-502404-73-00
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Atezolizumab

    Study Results

    No Results Posted as of Aug 1, 2023