ClinicaliQ Trial Snapshot
- A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC — Recruiting • Phase II • Oncology • NCT05968326.
- What is being tested: Adjuvant autogene cevumeran (personalised neoantigen vaccine) combined with atezolizumab (PD-L1 inhibitor) plus mFOLFIRINOX chemotherapy versus mFOLFIRINOX chemotherapy alone in patients with surgically resected pancreatic ductal adenocarcinoma (PDAC).
- Patient eligibility overview: Adults with completely resected PDAC who are fit enough to tolerate adjuvant chemotherapy and immunotherapy; typically includes patients with high-risk disease features who would otherwise receive standard mFOLFIRINOX treatment.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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, 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.