Navlimetostat + mFOLFIRINOX for Pancreatic Cancer

(M-POP Trial)

EB
DU
Overseen ByDuke University GI Oncology Research
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Daniel Nussbaum, M.D.
Must be taking: mFOLFIRINOX
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for individuals with localized pancreatic cancer. The goal is to determine if navlimetostat is safe and effective when combined with mFOLFIRINOX (a chemotherapy regimen) before and after surgery. Participants should have pancreatic cancer that hasn't spread, and their tumors must exhibit a specific genetic change called MTAP deletion. This trial could provide a new option for those newly diagnosed and not yet treated. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, giving participants the opportunity to be among the first to receive this new drug combination.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that navlimetostat is generally well-tolerated by patients. In earlier studies involving individuals with advanced pancreatic cancer, navlimetostat demonstrated lasting tumor-fighting effects with few serious side effects. Most patients managed the treatment well, experiencing a low occurrence of blood-related side effects.

Although navlimetostat remains under study, these results suggest it could be a safe option for treating pancreatic cancer. Navlimetostat is used in combination with mFOLFIRINOX, a chemotherapy treatment already employed for cancer. This combination aims to enhance effectiveness while keeping side effects manageable. Always consult a healthcare provider before deciding to join a clinical trial.12345

Why are researchers excited about this trial's treatments?

Navlimetostat is unique because it targets a specific enzyme involved in the progression of pancreatic cancer, potentially offering a more precise approach than current treatments. Most treatments for pancreatic cancer, like the standard mFOLFIRINOX chemotherapy regimen, attack rapidly dividing cells in general, which can affect both cancerous and healthy cells. Navlimetostat, on the other hand, is designed to interfere directly with cancer cell growth pathways, which might reduce side effects and improve effectiveness. Researchers are excited about this treatment because it could provide a more targeted and potentially less toxic option for patients.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that navlimetostat, under study in this trial, may help treat pancreatic cancer. In one study, patients lived for an average of 20 months, longer than with other treatments. This suggests that, on average, patients experienced extended survival. The treatment also delayed cancer progression for a longer period. Although more information is needed, these early results suggest navlimetostat could be a promising option for pancreatic cancer with MTAP deletion.678910

Who Is on the Research Team?

DN

Daniel Nussbaum, MD

Principal Investigator

Duke University

JS

John Strickler, MD

Principal Investigator

Mayo Clinic Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with localized pancreatic cancer whose tumors have an MTAP gene deletion. Participants should be eligible for surgery and able to receive chemotherapy. Those with other serious health issues or who can't tolerate the treatments may not qualify.

Inclusion Criteria

IOCBP must use hormonal plus non-hormonal contraception or non-hormonal contraception alone as highly effective method
Breastfeeding partners of male participants advised to consult healthcare provider about contraception during condom use period
I am fully active or restricted in physically strenuous activity only.
See 14 more

Exclusion Criteria

I am not taking any medications that are not allowed with the study drugs.
Concurrent severe or uncontrolled medical conditions compromising study participation
Known hypersensitivity to active substances or excipients
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Navlimetostat dose optimization combined with mFOLFIRINOX before surgery

4 weeks
Visits as per protocol for dose optimization

Surgery

Participants undergo surgical resection after completing mFOLFIRINOX

Within 60 days post-treatment

Phase 2 Treatment

Navlimetostat expansion combined with mFOLFIRINOX post-surgery

Up to 15 months
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • mFOLFIRINOX
  • Navlimetostat

Trial Overview

The study tests navlimetostat (an experimental drug) combined with a modified FOLFIRINOX chemo regimen, given before and after surgery, to find the safest dose and see how well patients tolerate it.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Navlimetostat Phase 2Experimental Treatment2 Interventions
Group II: Navlimetostat Phase 1bExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daniel Nussbaum, M.D.

Lead Sponsor

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

The Value of Survival Gains in Pancreatic Cancer from ...

Metastatic pancreatic cancer (mPC) is associated with low survival, with less than 10% of patients surviving 5 years. from 3.1 to 4.5 months.

Real world outcomes of metastatic pancreatic cancer (mPC ...

Following diagnosis of metastatic or recurrent disease, 57% of pts received nal-IRI in the first or second line, and 43% in third line or later ...

Key Clinical Takeaways and Emerging Data in Metastatic ...

Panelists reflect on how efficacy data, tolerability considerations, and patient centered factors influence regimen selection in everyday ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37167100/

Clinical outcome and safety profile of metastatic pancreatic ...

The median overall survival and progression-free survival were 20 months (hazard ratio [HR] 0.28, 95% confidence interval [CI]: 0.17-0.44) and ...

A Study Comparing Navlimetostat (BMS-986504) in ...

The purpose of this study is to assess the safety and efficacy of Navlimetostat (BMS-986504), Untreated Metastatic Pancreatic Ductal ...

Abstract PR013: Navlimetostat (BMS-986504) with or without ...

Navlimetostat monotherapy showed durable antitumor activity and was well tolerated in pts with heavily pretreated advanced PDAC.

Navlimetostat (BMS-986504) in patients with advanced ...

pancreatic cancer (invasive carcinoma with adenosquamous features and neuroendocrine), Depending on safety observations, smaller dose increments were used.

A Study Comparing Navlimetostat (BMS-986504) in ...

The purpose of this study is to assess the safety and efficacy of Navlimetostat (BMS-986504), Metastatic Pancreatic Ductal Adenocarcinoma … ...

A Study of Perioperative Navlimetostat Combined With ...

The purpose of this study is to assess the safety, feasibility, and recommended dose of navlimetostat (BMS-986504) combined with mFOLFIRINOX ...

Trial ID CA240-0030 | NCT07076121

The purpose of this study is to assess the safety and efficacy of Navlimetostat (BMS-986504), a selective, MTA-cooperative PRMT5 inhibitor, in combination ...