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RECRUITING Phase 2

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

NCT05968326 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Atezolizumab
  • DRUG mFOLFIRINOX
  • DRUG Autogene cevumeran

Study Locations (20)

California

  • USC Norris Comprehensive Cancer Center — Los Angeles
  • USC Norris Cancer Center — Newport Beach
  • University of California, San Francisco (UCSF) — San Francisco
  • University of California Los Angeles — Santa Monica

Connecticut

  • St. Francis Hospital and Medical Center — Hartford
  • Smilow Cancer Center — New Haven
  • Yale Cancer Center — New Haven
  • Smilow Cancer Hospital Care Center at Trumbull — Trumbull

New Jersey

  • Memorial Sloan Kettering Cancer Center Basking Ridge — Basking Ridge
  • Memorial Sloan Kettering Cancer Center — Middletown
  • Memorial Sloan Kettering Cancer Center at Bergen — Montvale

Massachusetts

  • Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center — Boston
  • Boston Medical Center (BMC) - Cancer Care Center — Boston

New York

  • Memorial Sloan Kettering Cancer Center - Commack — Commack
  • Memorial Sloan Kettering Cancer Center at Westchester — Harrison

Illinois

  • Northwestern Memorial Hospital — Chicago

Indiana

  • Indiana University Health Melvin & Bren Simon Cancer Center — Indianapolis

Kentucky

  • University of Kentucky Medical Center — Lexington

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2023-10-18
Est. Completion 2031-01-01
Phase Phase 2

Sponsor

Genentech

206 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05968326

The ClinicalTrials.gov registry entry for NCT05968326 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Adenocarcinoma, Pancreatic Ductal appearing as the primary indexed condition, and to 3 interventions — of which Atezolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05968326 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Connecticut, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05968326 about?

NCT05968326 is a clinical study titled "A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC". 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) w...

What is the current status of trial NCT05968326?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2023-10-18. Estimated completion is 2031-01-01.

What conditions does trial NCT05968326 study?

This clinical trial studies the following conditions: Adenocarcinoma, Pancreatic Ductal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05968326?

The interventions under investigation include: Atezolizumab (DRUG), mFOLFIRINOX (DRUG), Autogene cevumeran (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05968326?

This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05968326 being conducted?

This trial has 20 study locations across California, Connecticut, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial