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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2M-POPNCT07905131

A Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer

A Phase 1/2 study testing Navlimetostat and mFOLFIRINOX Treatment Regimen in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Daniel Nussbaum, M.D. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, feasibility, and recommended dose of navlimetostat (BMS-986504) combined with mFOLFIRINOX before and after surgery in patients with localized pancreatic cancer with MTAP deletion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
Navlimetostat and mFOLFIRINOX Treatment Regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
15 Jan 2027to 30 Jun 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Histologically and/or cytologically confirmed pancreatic ductal adenocarcinoma.
  • MTAP deletion or loss in tumor tissue as diagnosed by next generation sequencing.
  • Treatment naïve and clinically staged as resectable or borderline resectable, without evidence of distant metastatic disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Eligible to receive mFOLFIRINOX and undergo curative-intent pancreatic resection.
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  • Females are eligible to participate if they are not pregnant or breastfeeding. If childbearing potential must have a negative serum or urine pregnancy test at screening. IOCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception (as described in Appendix B).
  • WOCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception (as described in Appendix B).
  • A female (as assigned at birth) is eligible to participate if they are not pregnant or breastfeeding and at least 1 of the following conditions applies:
  • Is not an IOCBP, OR
  • Is an IOCBP and using a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of < 1% per year), as described in Appendix B, during the intervention period and for at least 9 months after the last dose of study intervention, or according to approved local product label requirements for individual agents, whichever is longer. IOCBP participants must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
  • Females of child-bearing potential and males with partners of child-bearing potential must agree not to donate eggs (ova, oocytes) for the purpose of reproduction or sperm and to practice sexual abstinence or use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 9 months after the last dose of the study medication.
  • If needed, male (as assigned at birth) participants should be advised to seek advice about sperm donation and cryopreservation of germ cells before treatment.
  • Breastfeeding partners of male (as assigned at birth) participants should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms.
  • Capable of understanding and complying with the protocol requirements and has signed the informed consent document.
  • Adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥ 1,500/μl
  • Platelets ≥ 100,000/μl
  • Hemoglobin > 9 g/dL
  • AST/ALT ≤ 3 X upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
  • Calculated CrCL ≥50 mL/min using the Cockcroft-Gault formula.
  • INR or PT ≤ 1.5× ULN; if receiving anticoagulant therapy, PT or aPTT should be within therapeutic range.
  • Provide written, informed consent to participate in the study and follow the study procedures.
  • Willing to provide mandatory tissue and blood samples for research purposes.

Who cannot join

  • Prior treatment for pancreatic adenocarcinoma other than up to two doses of mFOLFIRINOX administered prior to initiation of navlimetostat.
  • Concurrent severe and/or uncontrolled medical conditions which may compromise participation in the study.
  • Female patients who are pregnant or breast feeding.
  • Patients of either sex, not willing to use an effective method of birth control.
  • Live vaccines within 30 days of planned start of study medication, during treatment and for 90 days after treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine.
  • Patients taking medications specified by the protocol as prohibited for administration in combination with study drugs.
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  • Radiotherapy to the primary tumor prior to or planned post-surgery.
  • Inability to swallow pills or any significant gastrointestinal disease which would preclude the adequate oral absorption of medications.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the start of study or anticipation of need for major surgical procedure during the course of the study other than surgical resection of the pancreatic tumor.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to study enrollment.
  • Cardiac abnormalities including:
  • LVEF < 50%
  • QTcF prolongation > 480 msec, except for right bundle branch block, per the investigator's assessment.
  • Uncontrolled/symptomatic or significant cardiovascular conditions within 6 months prior to randomization, including, but not limited to, any of the following: cardiac angioplasty or stenting, unstable angina pectoris, myocardial infarction, stroke/transient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association class III-IV congestive heart failure, pericarditis, myocarditis, atrial fibrillation, or other arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
  • Ongoing need for a medication with a known risk of Torsades de Pointes that cannot be switched to alternative treatment prior to study entry.
  • HIV seropositivity, active hepatitis B or C infection, or other serious chronic infection requiring ongoing treatment.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
  • Known chronic liver disease, autoimmune hepatitis, or sclerosing cholangitis.
  • Receiving any other agent which would be considered as a treatment for the primary neoplasm.
  • Treatment with another investigational device or study drug or participation in another drug study within 30 days of screening. Other investigational procedures while participating in this study are excluded.
  • Known hypersensitivity to the active substances or to any of the excipients.
  • Patients with another malignancy for which treatment is required, per investigator's clinical judgment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily Bolch contact

919-668-6359

emily.bolch@duke.edu

Duke University GI Oncology Research contact

919-668-1861

gi-oncology-cru@dm.duke.edu

United States1 site

  • Duke University

    Durham, North Carolina, 27710

    Emily Bolch, 9196686359, emily.bolch@duke.edu

    Duke GI Oncology Research Office, 919-668-1861, gi-oncology-cru@dm.duke.edu

Other trials in United States

About this study

Official title: M-POP: A Phase Ib/II Open Label Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer

The purpose of this study is to assess the safety, feasibility, and recommended dose of navlimetostat (BMS-986504) combined with mFOLFIRINOX before and after surgery in patients with localized pancreatic cancer with MTAP deletion.

Being tested
Navlimetostat, mFOLFIRINOX Treatment Regimen
Keywords
Pancreatic cancer, Resectable pancreatic cancer, Localized pancreatic cancer, MTAP deleted pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavlimetostatDrug

    Also called BMS-986504, MRTX1719

    Investigational, small molecule anticancer agent being developed for the treatment of malignancies with homozygous deletion of the MTAP gene.

  • mFOLFIRINOX Treatment RegimenDrug

    Chemotherapy regimen composed of 5-fluorouracil, oxaliplatin, irinotecan, and leucovorin

Study groups in NCT07905131
Study groupRoleWhat they receive
Navlimetostat Phase 1bExperimentalPhase 1b Navlimetostat dose optimization
Receives: Drug: Navlimetostat; Drug: mFOLFIRINOX Treatment Regimen
Navlimetostat Phase 2ExperimentalPhase 2 Navlimetostat expansion
Receives: Drug: Navlimetostat; Drug: mFOLFIRINOX Treatment Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events

    Adverse events are assessed at every study visit and logged according to NCI-CTCAE v6.0.

    Measured: Up to 15 months

  2. Recommended phase 2 dose of navlimetostat, as measured by the number of participants who experience a dose limiting toxicity during the first cycle of the phase 1b portion of the study

    Dose limiting toxicities are assessed throughout the first 28 days on combination treatment and are logged according to NCI-CTCAE v6.0

    Measured: Dose limiting toxicities are assessed throughout the first 28 days on combination treatment.

  3. Feasibility of perioperative navlimetostat combined with mFOLFIRINOX

    Feasibility is measured by the proportion of evaluable participants who receive at least four doses of mFOLFIRINOX and at least one dose of navlimetostat prior to surgery, undergo surgical resection within 60 days of completing mFOLFIRINOX, and do not experience significant unexpected postoperative complications considered at least possibly related to navlimetostat within 14 days of surgery.

    Measured: Measured from the start of study treatment with navlimetostat through 14 days after surgery.

  4. Severity of Adverse Events

    Adverse events are assessed at every study visit and logged according to NCI-CTCAE v6.0.

    Measured: Up to 15 months

  5. Incidence of dose limiting toxicities

    Incidence of protocol-defined dose limiting toxicites, as assessed and graded per NCI-CTCAE v 6.0.

    Measured: The first 28 days of combination treatment

Secondary outcomes (4)

  1. Pathologic response rate

    Pathologic response rate is measured by College of American Pathologists (CAP) score of patients who undergo surgery. CAP scores range from 0-3, where 0=Complete response and 3=Poor or no response.

    Measured: Measured within one week post-operatively

  2. Recurrence free survival (RFS)

    RFS is defined as the time from surgery to documented recurrence or death due to any cause.

    Measured: Up to three years

  3. Overall survival (OS)

    OS is defined as the time from the first dose of navlimetostat to death due to any cause.

    Measured: Up to three years

  4. Event free survival (EFS)

    EFS is defined as the time from the first dose of navlimetostat to clinical or radiographic progression, death due to any cause, or navlimetostat discontinuation due to toxicity

    Measured: Up to three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start15 Jan 2027 (estimated)
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07905131
Sponsor's protocol ID
PRO00120979
Acronym
M-POP
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Navlimetostat and mFOLFIRINOX Treatment Regimen in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Daniel Nussbaum, M.D. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily Bolch (919-668-6359, emily.bolch@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: Up to 15 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07905131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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