Trial 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
NCT ID:
NCT05968326
Condition:
Adenocarcinoma, Pancreatic Ductal
Conditions: Official terms:
Adenocarcinoma
Atezolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Autogene cevumeran
Description:
Autogene cevumeran will be administered intravenously (IV) at a recommended dose at
specified timepoints.
Arm group label:
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab will be administered IV at a dose of 1680 milligrams (mg) at specified
timepoints.
Arm group label:
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Other name:
Tecentriq
Intervention type:
Drug
Intervention name:
mFOLFIRINOX
Description:
mFOLFIRINOX (oxaliplatin, leucovorin, irinotecan, 5-FU) will be administered IV at
specified timepoints.
Arm group label:
Arm 1: Autogene Cevumeran + Atezolizumab + mFOLFIRINOX
Arm group label:
Arm 2: mFOLFIRINOX
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
USC Norris Cancer Center; USC Oncology Hematology Newport Beach
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California, San Francisco (UCSF)
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Los Angeles
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Facility:
Name:
St. Francis Hospital and Medical Center
Address:
City:
Hartford
Zip:
06105
Country:
United States
Status:
Recruiting
Facility:
Name:
Smilow Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Withdrawn
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
Smilow Cancer Hospital Care Center at Trumbull
Address:
City:
Trumbull
Zip:
06611
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern Memorial Hospital; Division of Gastroenterology and Hepatology
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Indiana University Health Melvin & Bren Simon Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kentucky Medical Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Facility:
Name:
Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center
Address:
City:
Boston
Zip:
02114-2621
Country:
United States
Status:
Recruiting
Facility:
Name:
Boston Medical Center (BMC) - Cancer Care Center
Address:
City:
Boston
Zip:
02118
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center; MSK Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center at Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center at Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health; Monter Cancer Center
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Health
Address:
City:
Mineola
Zip:
11501
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University Medical Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
11101
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center at Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Institute
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Cincinnati Cancer Institute
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Facility:
Name:
Miriam Hospital
Address:
City:
Providence
Zip:
02906
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Research Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Suspended
Facility:
Name:
St Michael Hospital; Hematology and Oncology
Address:
City:
Toronto
Zip:
M5B 1W8
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Centre hospitalier de l'Universite de Montreal (CHUM)
Address:
City:
Montreal
Zip:
H2X 0A9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Régional Universitaire de Lille
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Leon Berard; Service Oncologie Medicale
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)
Address:
City:
Bochum
Zip:
44892
Country:
Germany
Status:
Recruiting
Facility:
Name:
Clinica Universitaria de Navarra (CUN)
Address:
City:
Pamplona/iruña
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universitaria de Navarra de Madrid; Servicio de Hepatologia; Servicio de Hepatologia
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Centro Integral Oncológico Clara Campal Ensayos Clínicos START
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Sahlgrenska Universitetssjukhuset; Onkology
Address:
City:
Gothenburg
Zip:
41 343
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Karolinska Universitetssjukhuset
Address:
City:
Stockholm
Zip:
171 76
Country:
Sweden
Status:
Recruiting
Facility:
Name:
University Hospitals Birmingham NHS Foundation Trust; QEHB Pharmacy Department
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Hammersmith Hospital; Dept of Oncology
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Status:
Recruiting
Start date:
October 18, 2023
Completion date:
December 27, 2029
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Collaborator:
Agency:
BioNTech SE
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05968326
