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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502404-73-00

Acronym

GO44479

Enrollment

204

Registered

2023-12-19

Start date

2024-06-03

Completion date

Unknown

Last updated

2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic ductal adenocarcinoma

Brief summary

1. DFS after randomization

Detailed description

1. OS after randomization, 2. DFS rates at 12, 24, and 36 months, 3. OS rates at 3 and 5 years, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) grading scale, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. DFS after randomization	—

Secondary

Measure	Time frame
1. OS after randomization, 2. DFS rates at 12, 24, and 36 months, 3. OS rates at 3 and 5 years, 4. Incidence and severity of adverse events, with severity determined according to National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) grading scale, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Netherlands, Spain, Sweden

Outcome results