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New triple therapy aims to stop pancreatic Cancer's return after surgery

NCT ID NCT05968326

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 8 times

Summary

This Phase 2 trial tests whether adding a personalized cancer vaccine (autogene cevumeran) and an immunotherapy drug (atezolizumab) to standard chemotherapy (mFOLFIRINOX) can keep pancreatic cancer from coming back after surgery. About 260 people whose tumors were completely removed and who have no signs of remaining cancer will be randomly assigned to receive either the combination or chemo alone. The main goal is to see how long participants stay cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autogene cevumeran (personalized cancer vaccine) plus atezolizumab (immunotherapy) and mFOLFIRINOX (chemotherapy)
What this could lead to
If it works, this combination could help prevent pancreatic cancer from coming back after surgery, offering a new option for long-term disease control.
What could go wrong
This is an early Phase 2 trial with only 260 participants. The approach is complex and may cause significant side effects. Success is not guaranteed, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 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).

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Conditions

The condition(s) this trial relates to.

adenocarcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenocarcinoma, pancreatic ductal

Contacts and locations

Locations

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV, Netherlands

  • Antwerp University Hospital

    Edegem, VAN, 2650, Belgium

  • Barts Health NHS Trust

    London, EC1A 7BE, United Kingdom

  • Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • Boston Medical Center (BMC) - Cancer Care Center

    Boston, Massachusetts, 02118, United States

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496, South Korea

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, 59037, France

  • Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital

    Montreal, Quebec, H2L 4M1, Canada

  • Centre Leon Berard

    Lyon, 69008, France

  • Centro Integral Oncológico Clara Campal Ensayos Clínicos START

    Madrid, 28050, Spain

  • Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

    Berlin, 13353, Germany

  • Clatterbridge Cancer Centre Liverpool

    Liverpool, LIV, L7 8YA, United Kingdom

  • Clinica Universitaria de Navarra (CUN)

    Pamplona/iruña, Navarre, 31008, Spain

  • Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia

    Madrid, 28027, Spain

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710-4000, United States

  • Erasmus MC

    Rotterdam, 3000 CA, Netherlands

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • Guys Hospital

    London, SE1 9RT, United Kingdom

  • Harvard Medical School - Massachusetts General Hospital (MGH) - Cancer Center

    Boston, Massachusetts, 02114-2621, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202-2610, United States

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, Malaga, 29010, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall d Hebron

    Barcelona, 08035, Spain

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Indiana University Health Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Catala d?Oncologia Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Karolinska Universitetssjukhuset

    Solna, 171 64, Sweden

  • Katholisches Klinikum Bochum gGmbH;St. Josef-Hospital

    Bochum, 44791, Germany

  • Klinikum Bogenhausen

    München, 81925, Germany

  • Krankenhaus Nordwest GmbH

    Frankfurt, 60488, Germany

  • Ludwig-Maximilians-Universität München

    München, 81377, Germany

  • MEETH-LHH Northwell Health Cancer Clinical Trials Office at MEETH-LHH

    New York, New York, 10065-7471, United States

  • Memorial Sloan Kettering Cancer Center

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center - Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center at Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center at Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Cancer Center at Westchester

    Harrison, New York, 10604, United States

  • Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • Mount SInai Medical Center

    New York, New York, 10029, United States

  • National Cancer Center (NCC) Hospital - Center for Liver and Pancreatobiliary Cancer

    Goyang-si, 410-769, South Korea

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41 343, Sweden

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620, South Korea

  • Severance Hospital - Yonsei Cancer Center

    Seoul, 120-752, South Korea

  • Smilow Cancer Hospital Care Center at Trumbull

    Trumbull, Connecticut, 06611, United States

  • St Michael Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105, United States

  • The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)

    Seocho, 06591, South Korea

  • ULB Hôpital Erasme

    Brussels, 1070, Belgium

  • UMC Radboud Nijmegen

    Nijmegen, 6500 HB, Netherlands

  • USC Norris Cancer Center

    Newport Beach, California, 92663, United States

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uniklinikum Würzburg, Med. Klinik und Poliklinik II

    Würzburg, 97080, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University College London Cancer Institute

    London, WC1E 6DD, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH, United Kingdom

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94158-2350, United States

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45219, United States

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536, United States

  • University of Nebraska

    Omaha, Nebraska, 68198-5300, United States

  • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)

    Songpa-gu, 05505, South Korea

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Essen

    Essen, 45122, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Ulm, Klinik für Innere MedizinInnere Medizin III Studienzentrale

    Ulm, 89081, Germany

  • Yale Cancer Center

    New Haven, Connecticut, 06520, United States