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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)

Primary Purpose

Adenocarcinoma, Pancreatic Ductal

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autogene cevumeran
Atezolizumab
mFOLFIRINOX
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma, Pancreatic Ductal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center Basking RidgeRecruiting
  • Memorial Sloan Kettering Cancer Center; MSK MonmouthRecruiting
  • Memorial Sloan Kettering Cancer Center at BergenRecruiting
  • Memorial Sloan Kettering Cancer Center - CommackRecruiting
  • Memorial Sloan Kettering Cancer Center at WestchesterRecruiting
  • Columbia University Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering Cancer Center at NassauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX

Arm 2: mFOLFIRINOX

Arm Description

Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.

Participants will receive mFOLFIRINOX.

Outcomes

Primary Outcome Measures

Disease Free Survival (DFS)

Secondary Outcome Measures

DFS Rates at 12, 24, and 36 Months
Overall Survival (OS)
OS Rates at 3 and 5 Years
Percentage of Participants With Adverse Events (AEs)

Full Information

First Posted
July 21, 2023
Last Updated
October 5, 2023
Sponsor
Genentech, Inc.
Collaborators
BioNTech SE
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1. Study Identification

Unique Protocol Identification Number
NCT05968326
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
Acronym
IMCODE003
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Anticipated)
Primary Completion Date
May 22, 2029 (Anticipated)
Study Completion Date
May 22, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
BioNTech SE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Pancreatic Ductal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Arm Type
Experimental
Arm Description
Participants will receive autogene cevumeran, atezolizumab and mFOLFIRINOX.
Arm Title
Arm 2: mFOLFIRINOX
Arm Type
Active Comparator
Arm Description
Participants will receive mFOLFIRINOX.
Intervention Type
Drug
Intervention Name(s)
Autogene cevumeran
Intervention Description
Autogene cevumeran will be administered intravenously (IV) at a recommended dose at specified timepoints.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified timepoints.
Intervention Type
Drug
Intervention Name(s)
mFOLFIRINOX
Intervention Description
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at specified timepoints.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
DFS Rates at 12, 24, and 36 Months
Time Frame
Months 12, 24, 36
Title
Overall Survival (OS)
Time Frame
From randomization to death from any cause (up to approximately 6 years)
Title
OS Rates at 3 and 5 Years
Time Frame
Years 3 and 5
Title
Percentage of Participants With Adverse Events (AEs)
Time Frame
Up to approximately 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GO44479 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center; MSK Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center at Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center at Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center at Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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