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Compares treatment options for Adenocarcinoma, Pancreatic Ductal
Official title A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
ClinicalTrials.gov ID: NCT05968326
What this study is testing
What is Autogene cevumeran?
Autogene cevumeran is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenocarcinoma, pancreatic ductal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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...
- Disorders of the colon or rectum, or postoperative complication leading to Grade \>/=2 diarrhea
See the full eligibility 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 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Newport Beach, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Omaha, Nebraska, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- Lake Success, New York, United States
- New York, New York, United States
+ 50 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Newport Beach, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Hartford, Connecticut, United States; New Haven, Connecticut, United States and 64 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.