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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 PDAC
Trial Status: active
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.
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. 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).
Additional locations may be listed on ClinicalTrials.gov for NCT05968326.
