NCT04172532 · National Cancer Institute (NCI)
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
What this study is about
This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
View original scientific description
This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Interventions
PROCEDURE
Biopsy Procedure
Undergo tissue collection
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Computed Tomography
Undergo CT
RADIATION
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
Peposertib
Given PO
OTHER
Placebo Administration
Given PO
Primary outcome measures
Maximum tolerated dose (Phase I)
Time frame: Up to 14 days
Recommended phase 2 dose (Phase I)
Time frame: Up to 14 days
Progression-free survival rate (Phase II)
Time frame: Time from randomization to progression or death whichever occurs first, assessed up to 2 years
The 95% confidence intervals will be provided.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients must have pathologically confirmed pancreatic adenocarcinoma. Patients with alternative or mixed histologies (i.e., squamous, neuroendocrine, acinar, colloid) are not eligible
- Received 4-6 months of induction chemotherapy with fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX), fluorouracil, liposomal irinotecan, luecovorin, oxaliplatin (NALIRIFOX), or gemcitabine/Abraxane, as per standard of care
- Patients must have locally advanced pancreatic cancer according to National Comprehensive Cancer Network (NCCN) Guidelines (version 1.2020) on pancreas protocol CT scan performed within 21 days of registration. Locally advanced disease is defined as any of the following:
- For head or uncinate process tumors:
- Solid tumor contact with superior mesenteric artery \> 180 degrees
- Solid tumor contact with the celiac axis \> 180 degrees
- Solid tumor contact with the common or proper hepatic arteries \> 180 degrees or
Where
- Duarte, California
- Irvine, California
- Orange, California
- Sacramento, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Chicago, Illinois
- Fairway, Kansas
- Hays, Kansas
- Kansas City, Kansas
- Lawrence, Kansas
- Olathe, Kansas
And 26 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations