Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery
Phase 1 Clinical Trial of Personalized Neoantigen Tumor Vaccines and Programmed Death-Ligand 1 (PD-L1) Blockade in Patients With Surgically Resected Pancreatic Cancer
1 other identifier
interventional
29
1 country
7
Brief Summary
The purpose of this study is to evaluate the safety or treating pancreatic cancer with surgery to remove cancerour tissue, followed by atezolizumab, followed by a personalized cancer vaccine (PCV), and then with chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pancreatic-cancer
Started Dec 2019
Longer than P75 for phase_1 pancreatic-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedStudy Start
First participant enrolled
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 11, 2026
January 7, 2026
January 1, 2026
6.9 years
November 12, 2019
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Drug related toxicity
The primary objective of this trial is to evaluate the safety of a personalized tumor vaccine combined with atezolizumab and mFOLFIRINOX
2 years
Study Arms (1)
Pancreatic Cancer
EXPERIMENTALRadiologically resectable primary pancreatic tumors
Interventions
Atezolizumab will be administered 6 weeks post-tumor resection (+/- 2 weeks)
RO7198457 will be administered 9 weeks post-tumor resection (+/- 2 weeks)
mFOLFIRINOX regimen will be administered 21 weeks post-tumor resection (+/- 2 weeks)
Eligibility Criteria
You may qualify if:
- Subjects must be \>/= 18 years of age at time of informed consent
- Able to comply with the study protocol, in the investigator's judgment
- Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection
- Tumors must be radiographically resectable, defined as:
- A clear fat plane around the celiac and superior mesenteric arteries
- patent superior mesenteric and portal veins without primary tumor involvement
- No encasement of the superior mesenteric vein or portal veins
- No encasement of the superior mesenteric or hepatic arteries
- No metastatic disease
- No extra-regional nodal disease
- Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation. Subjects with neuroendocrine (and mixed type) tumors are excluded
- Pancreatic cancer surgical staging: T 1-3, N0-2, M0
- ° Per AJCC 8th edition staging
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status (Section 20.0 APPENDICES, Appendix1)
- Subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for PDAC
- +7 more criteria
You may not qualify if:
- Prior neoadjuvant treatment or radiation therapy for PDAC
- Prior therapy with uPD-1 antibody or any other immune therapy
- Borderline resectable, locally unresectable or metastatic PDAC
- Pancreas tumor histology other than PDAC
- Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment
- Life expectancy less than 12 weeks
- Inability to comply with study and/or follow-up procedures
- Any other malignancy for which the patient is undergoing active treatment which will be concurrent with the investigational agent in this study.
- Patients with unresolved Clavien-Dindo \>/= Grade 3 (Section 20.0 APPENDICES ,Appendix 2) postoperative complications
- Actie, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Active tuberculosis
- Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications
- Known hypersensitivity or allergy to the active substance or to any of the excipients of RO7198457, atezolizumab, oxaliplatin, leucovorin, irinotecan, or fluorouracil
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
- History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa)
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- Genentech, Inc.collaborator
- Massachusetts Institute of Technologycollaborator
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Rockville Centre, New York, 11570, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vinod Balachandran, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2019
First Posted
November 13, 2019
Study Start
December 13, 2019
Primary Completion (Estimated)
November 11, 2026
Study Completion (Estimated)
November 11, 2026
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.