Navlimetostat + mFOLFIRINOX for Pancreatic Cancer
(M-POP Trial)
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.12345Why 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?
Daniel Nussbaum, MD
Principal Investigator
Duke University
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1b Treatment
Navlimetostat dose optimization combined with mFOLFIRINOX before surgery
Surgery
Participants undergo surgical resection after completing mFOLFIRINOX
Phase 2 Treatment
Navlimetostat expansion combined with mFOLFIRINOX post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Phase 2 Navlimetostat expansion
Phase 1b Navlimetostat dose optimization
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daniel Nussbaum, M.D.
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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
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.
2.
resources.flatiron.com
resources.flatiron.com/publications/real-world-outcomes-of-metastatic-pancreatic-cancer-mpc-patients-pts-treated-with-liposomal-irinotecan-nal-iri-in-the-usReal 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 ...
3.
onclive.com
onclive.com/view/key-clinical-takeaways-and-emerging-data-in-metastatic-pancreatic-ductal-adenocarcinomaKey Clinical Takeaways and Emerging Data in Metastatic ...
Panelists reflect on how efficacy data, tolerability considerations, and patient centered factors influence regimen selection in everyday ...
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 ...
6.
aacrjournals.org
aacrjournals.org/cancerres/article/86/18_Supplement_2/PR013/788321/Abstract-PR013-Navlimetostat-BMS-986504-with-orAbstract PR013: Navlimetostat (BMS-986504) with or without ...
Navlimetostat monotherapy showed durable antitumor activity and was well tolerated in pts with heavily pretreated advanced PDAC.
7.
medcommsvdp.web.bms.com
medcommsvdp.web.bms.com/f5f8ca35-de1c-4635-8ba4-c127a1709f00/f676d981-d0cd-4d51-a4e8-86146032076d/f676d981-d0cd-4d51-a4e8-86146032076d_viewable_rendition__v.pdfNavlimetostat (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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.