BMS-986504 + Pemetrexed for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment that combines BMS-986504 (an experimental treatment) and pemetrexed to determine its safety and effectiveness for patients with certain cancers. Researchers focus on solid tumors missing the MTAP gene that have metastasized. BMS-986504 may inhibit tumor growth by interfering with enzymes that aid cell growth, while pemetrexed stops cells from using folic acid to make DNA, potentially killing tumor cells. The trial seeks patients diagnosed with metastatic solid tumors lacking the MTAP gene, which have progressed despite previous treatment. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering patients the opportunity to be among the first to receive this new therapy.
Do I need to stop taking my current medications for the trial?
The trial requires a 3-week (21 days) washout period (time without taking certain medications) from prior chemotherapy, radiation therapy, or targeted agents before starting the study treatment. Additionally, you must stop taking any medications that are strong inhibitors or inducers of certain liver enzymes (CYP3A4/P-gp) and any botanical preparations (like herbal supplements) before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BMS-986504, when combined with pemetrexed, might be safe and tolerable for individuals with certain advanced cancers. In studies, BMS-986504 targets a specific enzyme essential for cancer cell growth, while pemetrexed inhibits the use of a vitamin necessary for DNA synthesis. Although detailed safety data is not provided, the treatment's progression to Phase 1/2 trials indicates some evidence of safety in humans. This phase assesses how well individuals tolerate the treatment and any potential side effects. So far, the combination appears effective against tumors with a specific gene deletion, but ongoing trials aim to confirm this.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about BMS-986504 combined with pemetrexed because it introduces a novel approach to treating cancer. Most traditional cancer treatments target cell division indiscriminately, affecting both cancerous and healthy cells. BMS-986504 is designed to specifically target cancer cells, potentially leading to more efficient cancer cell eradication with fewer side effects. Additionally, its oral administration combined with pemetrexed's intravenous delivery offers a potentially more convenient and effective treatment regimen. This combination aims to improve outcomes by maximizing the efficacy of both drugs while minimizing toxicity.
What evidence suggests that the combination of BMS-986504 and pemetrexed could be effective for metastatic solid tumors with MTAP deletion?
Research has shown that the drug BMS-986504, when combined with pemetrexed, may help treat advanced solid tumors with a specific genetic change called MTAP deletion. Studies have found that BMS-986504 blocks an enzyme called PRMT5, which cancer cells require for growth. In patients with non-small cell lung cancer (NSCLC), BMS-986504 helped shrink tumors in about 29% of cases, meaning nearly one in three patients experienced tumor reduction. Pemetrexed works by preventing cancer cells from using folic acid, which they need to produce DNA. In this trial, participants will receive both BMS-986504 and pemetrexed, which together might more effectively stop tumor growth.12346
Who Is on the Research Team?
Devalingam Mahalingam, MD, PhD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for adults (18+) with metastatic solid tumors, mainly of the gastrointestinal tract (like pancreatic, biliary, esophageal, or colon cancer), whose tumors have an MTAP gene deletion. Participants must have tried at least one standard treatment before and have a tumor that can be measured on scans.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986504 orally once daily on days 1-21 and pemetrexed intravenously on day 1 of each 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986504
- Pemetrexed
Trial Overview
The study is testing a new drug called BMS-986504 (a PRMT5 inhibitor) combined with pemetrexed chemotherapy to see if this combination is safe and effective in people with advanced cancers missing the MTAP gene. The trial also involves biospecimen collection and CT scans.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive BMS-986504 PO QD on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
BMS-986504 in Combination With Pemetrexed for the ...
Giving BMS-986504 in combination with pemetrexed may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors with ...
Combination 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- ...
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 ...
Trial ID CA240-0029 | NCT07063745 - BMS Clinical Trials
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of ...
BMS-986504 in Combination With Pemetrexed for the ...
Will be summarized descriptively by frequency and grade using the NCI CTCAE v 5.0. Will be tabulated by system organ class and preferred term. Up to 30 days ...
A Randomized Phase 2/3 Study of BMS-986504 in ...
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of ...
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