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New combo targets tough pancreatic tumors

NCT ID NCT04172532

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Updated 11 times

Summary

This study tests a drug called M3814 combined with a special type of radiation for people with locally advanced pancreatic cancer (cancer that has spread nearby but not to distant organs). The goal is to find the safest dose and see if the combination helps stop tumor growth longer than radiation alone. About 92 adults who have already had standard chemotherapy will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 92 people

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

Started

Jan 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * 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, leucovorin, 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 * For pancreatic body or tail tumors: * Solid tumor contact of \> 180 degrees with the superior mesenteric artery or celiac axis * Solid tumor contact with the celiac axis and aortic involvement or * Unreconstructible superior mesenteric vein or portal vein due to tumor involvement or occlusion (can be due to tumor or bland thrombus) * The determination of locally advanced pancreatic cancer and plan for non-operative treatment on this clinical trial must be confirmed through local multi-disciplinary review * Measurable disease per response evaluation criteria in solid tumors (RECIST) version (v)1.1 * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of M3814 (peposertib) in combination with hypofractionated radiation in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Leukocytes \>= 4,000/mcL * Absolute neutrophil count \>= 1.5 x 10\^9/L. * Hemoglobin \>= 9 g/dL * Platelets \>= 100 x 10\^9/L * Total bilirubin =\< 2.0 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN * Creatinine =\< 1.5 x institutional ULN * Glomerular filtration rate (GFR) \>= 51 mL/min/1.73 m\^2 * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female patients of childbearing potential and male patients must be willing to use an adequate method of contraception for the course of the study through 12 weeks after the last dose of study medication. * Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function. To be eligible for this trial, patients should be American Heart Association Stage B (people without current or previous symptoms of heart failure but with either structural heart disease, increased filling pressures in the heart or other risk factors) or better and New York Heart Association Functional Classification II (slight limitation of physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain), or better * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible Exclusion Criteria: * Patients who have completed induction chemotherapy less than 2 weeks or more than 8 weeks prior to study enrollment * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy grade =\< 2 * Patients who are receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to M3814 (peposertib) * Evidence of distant metastatic disease * More than 1 line of chemotherapy for the treatment of localized pancreatic cancer, unless the change in treatment was made only for toxicity * Prior abdominal radiation * Active inflammatory bowel disease or connective tissue disease * Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents * History of anaphylactic reaction to iodinated intravenous (IV) contrast required for radiation simulation. Patients with mild reactions may be enrolled, but must receive premedications for contrast allergy prior to imaging * Patients who cannot discontinue concomitant medications or herbal supplements that are strong inhibitors or strong inducers of cytochrome P450 (CYP) isoenzymes CYP3A4/5, CYP2C9, and CYP2C19. Concomitant use of substrates with a narrow therapeutic index that are metabolized by CYP1A2, CYP2B6, CYP2C8, and CYP3A4/5 are also excluded. * Use caution with other substrates of CYP3A4/5, CYP1A2, CYP2B6, CYP2C8 and substrates of P-gp, BCRP, OCT1, OAT3, OATP1B1, OATP1B3, MATE1, and MATE-2K with a narrow therapeutic index. Close monitoring is advised. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. (Patient Drug Interactions Handout and Wallet Card) should be provided to patients * Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs). Patients may confer with the study doctor to determine if such medications can be discontinued. These must be discontinued \>= 5 days prior to study treatment. Patients do not need to discontinue calcium carbonate. H2 blockers and antacids are allowed. * Patients who have received a live attenuated vaccine within 30 days of dosing with M3814 (peposertib) * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because M3814 (peposertib) is a DNA-protein kinase (PK) inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M3814 (peposertib), breastfeeding should be discontinued if the mother is treated with M3814 (peposertib) * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Locally advanced pancreatic adenocarcinoma Stage III pancreatic cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

    Contact Email: •••••@•••••

  • City of Hope at Irvine Lennar

    RECRUITING

    Irvine, California, 92618, United States

  • Cooperman Barnabas Medical Center

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    ACTIVE_NOT_RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • HaysMed

    RECRUITING

    Hays, Kansas, 67601, United States

  • Huntsman Cancer Institute/University of Utah

    ACTIVE_NOT_RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Lawrence Memorial Hospital

    RECRUITING

    Lawrence, Kansas, 66044, United States

  • Mercy Hospital Pittsburg

    SUSPENDED

    Pittsburg, Kansas, 66762, United States

  • Monmouth Medical Center

    RECRUITING

    Long Branch, New Jersey, 07740, United States

  • Montefiore Medical Center - Moses Campus

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Einstein Campus

    ACTIVE_NOT_RECRUITING

    The Bronx, New York, 10461, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • NYP/Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • Northwestern University

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611, United States

  • Roswell Park Cancer Institute

    ACTIVE_NOT_RECRUITING

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Salina Regional Health Center

    RECRUITING

    Salina, Kansas, 67401, United States

  • Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • The University of Kansas Cancer Center - Olathe

    RECRUITING

    Olathe, Kansas, 66061, United States

    Contact Email: •••••@•••••

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UCHealth University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    RECRUITING

    Irvine, California, 92612, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University Health Truman Medical Center

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Cancer Center - Lee's Summit

    RECRUITING

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    RECRUITING

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center at North Kansas City Hospital

    SUSPENDED

    North Kansas City, Missouri, 64116, United States

  • University of Kansas Cancer Center-Overland Park

    RECRUITING

    Overland Park, Kansas, 66210, United States

  • University of Kansas Clinical Research Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • University of Kansas Health System Saint Francis Campus

    RECRUITING

    Topeka, Kansas, 66606, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    WITHDRAWN

    Lexington, Kentucky, 40536, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Vanderbilt University/Ingram Cancer Center

    SUSPENDED

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Health - Wilkes Medical Center

    ACTIVE_NOT_RECRUITING

    Wilkesboro, North Carolina, 28659, United States

  • Wake Forest University Health Sciences

    ACTIVE_NOT_RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Wake Forest University at Clemmons

    ACTIVE_NOT_RECRUITING

    Clemmons, North Carolina, 27012, United States

  • Wayne State University/Karmanos Cancer Institute

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48201, United States

  • Weisberg Cancer Treatment Center

    ACTIVE_NOT_RECRUITING

    Farmington Hills, Michigan, 48334, United States

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