BMS-986504 + Chemotherapy for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, BMS-986504, to determine its safety and effectiveness when combined with standard chemotherapy drugs for pancreatic cancer. It targets individuals with untreated metastatic pancreatic ductal adenocarcinoma (PDAC) who have a specific genetic change called MTAP deletion. Participants will receive either the new drug with chemotherapy or a placebo with chemotherapy. This trial suits those who have not yet received treatment for their metastatic cancer and possess this genetic profile. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that BMS-986504 is well tolerated by patients. Most side effects were mild, with only 14% of patients experiencing moderate issues in studies on solid tumors. This suggests it is relatively safe for most people.
The combination of gemcitabine and nab-paclitaxel also treats pancreatic cancer. Research has shown it improves survival rates compared to using gemcitabine alone. Side effects can occur, but they are usually manageable. These drugs are widely used, which adds reassurance about their safety.
Overall, both BMS-986504 and the gemcitabine-nab-paclitaxel combination have demonstrated promising safety profiles in previous research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about BMS-986504 combined with chemotherapy for pancreatic cancer because it represents a new approach to treatment. Most current therapies, like gemcitabine and nab-paclitaxel, work by targeting rapidly dividing cancer cells. However, BMS-986504 introduces a novel mechanism that may enhance the immune system's ability to fight cancer. This combination has the potential to improve outcomes by not just attacking cancer cells directly but also by empowering the body's own defenses. This dual-action strategy could lead to more effective and longer-lasting results for patients.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
This trial tests BMS-986504 in combination with chemotherapy for pancreatic cancer. Research has shown that BMS-986504, when combined with other treatments, might help treat certain cancers. In one study, BMS-986504 shrank or eliminated tumors in about 29% of patients with non-small cell lung cancer and a specific genetic deletion. Additionally, the combination of gemcitabine and nab-paclitaxel has been shown to extend life and slow disease progression in pancreatic cancer patients. This trial now tests these treatments together to determine their effectiveness against pancreatic cancer, particularly in those with a specific gene deletion.12678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for individuals with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) that have a specific genetic change called homozygous MTAP deletion. Detailed eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986504 in combination with Nab-paclitaxel and Gemcitabine or placebo in combination with Nab-paclitaxel and Gemcitabine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986504
- Gemcitabine
- Nab-paclitaxel
Trial Overview
The study tests the safety and effectiveness of BMS-986504 combined with chemotherapy drugs Nab-paclitaxel and Gemcitabine versus a placebo combined with the same chemotherapy in patients with PDAC. The goal is to see if BMS-986504 improves treatment outcomes.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead 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
NCT07076121 | A Study Comparing BMS-986504 in ...
The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with ...
Bristol Myers Squibb to Present Data at ASCO® 2025 ...
Data from more than 80 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning more than 20 cancer types. “ ...
BMS-986504 Demonstrates Durable Responses in MTAP- ...
Among clinically evaluable patients in the NSCLC cohort (n=35), BMS-986504 demonstrated a 29% overall response rate (ORR) and a 80% disease ...
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aacrjournals.org
aacrjournals.org/cancerres/article/85/18/3540/764439/Combination-of-the-MTA-Cooperative-PRMT5-InhibitorCombination of the MTA-Cooperative PRMT5 Inhibitor BMS ...
Combination of the MTA-Cooperative PRMT5 Inhibitor BMS-986504 and KRAS Inhibitors Is an Effective Treatment Strategy for MTAP-Deleted KRAS-Mutant Pancreatic ...
BMS‐986504 News
BMS-986504 demonstrated a favorable PK/PD profile, supporting QD dosing at 400 and 600 mg. These results support further investigation of BMS-986504 at 400 and ...
A Study Comparing BMS-986504 in Combination With Nab ...
The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/ ...
Combination of the MTA-Cooperative PRMT5 Inhibitor ...
Combination of the MTA-Cooperative PRMT5 Inhibitor BMS-986504 and KRAS Inhibitors Is an Effective Treatment Strategy for MTAP-Deleted KRAS- ...
A Study Comparing BMS-986504 in Combination With Nab ...
The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/ ...
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