17 Participants NeededMy employer runs this trial

BMS-986504 for Peripheral Nerve Sheath Tumor

AM
Overseen ByAnkit Mangla, MD
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 explores a new treatment called BMS-986504, an experimental drug, for Malignant Peripheral Nerve Sheath Tumor (MPNST). The researchers aim to determine if this medicine outperforms current options, particularly in patients with a specific genetic change known as MTAP loss. This genetic change might enhance the treatment's effectiveness. Individuals diagnosed with MPNST, whose tumors cannot be surgically removed, and who have the MTAP loss may be suitable candidates for the trial. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot use any strong inhibitors or inducers of CYP3A4, P-gp, or proton pump inhibitors unless they can be switched to an alternative treatment before starting the study.

Is there any evidence suggesting that BMS-986504 is likely to be safe for humans?

Research has shown that BMS-986504 is usually well-tolerated by patients. In earlier studies, most side effects were mild and not serious, with only about 14% of participants experiencing more serious side effects. Researchers are testing this treatment for its ability to target MPNST, particularly when surgery isn't an option. Early results are promising, suggesting it might be a safe option for many people.12345

Why do researchers think this study treatment might be promising for MPNST?

Unlike the standard treatments for peripheral nerve sheath tumors, which often involve surgery, radiation, and chemotherapy, BMS-986504 represents a new approach by potentially targeting specific molecular pathways involved in tumor growth. Researchers are excited about BMS-986504 because it could offer a more targeted treatment option, minimizing damage to surrounding healthy tissues and potentially leading to fewer side effects. This drug is also being tested for its ability to halt disease progression more effectively than existing therapies, which could significantly improve patient outcomes.

What evidence suggests that BMS-986504 might be an effective treatment for MPNST?

Research suggests that the drug BMS-986504, which participants in this trial will receive, might help treat Malignant Peripheral Nerve Sheath Tumor (MPNST), particularly in tumors lacking the MTAP gene. BMS-986504 blocks an enzyme called PRMT5, which aids cancer cell growth. In other cancers, such as non-small cell lung cancer (NSCLC), about 29% of patients experienced tumor shrinkage with BMS-986504. Notably, this drug has little effect on tumors without the MTAP gene change, indicating it specifically targets tumors with this genetic difference. Overall, this offers hope for its potential effectiveness in treating MPNST with MTAP loss.12367

Who Is on the Research Team?

AM

Ankit Mangla, MD

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals

Are You a Good Fit for This Trial?

This trial is for people age 12 and older with an unresectable malignant peripheral nerve sheath tumor (MPNST) whose tumor has a specific gene loss called MTAP deletion. Participants must have recovered from previous treatments, have good organ function, and be able to swallow tablets. Prior use of certain drugs or some stomach conditions may exclude participation.

Inclusion Criteria

I am 12 years old or older.
I am able and willing to sign consent forms for this study.
Pathohistological verification of MPNST
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Exclusion Criteria

I have been treated with a PRMT5 inhibitor before.
Participants with active drug use
I am unable to swallow tablets.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986504 on Days 1-28 of each cycle until disease progression, unacceptable toxicity, or withdrawal of consent

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post-treatment discontinuation

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986504

Trial Overview

The study is testing a new drug called BMS-986504 in people with MPNST who have MTAP loss. The goal is to see if this medicine works better than current options and to check its safety. All participants will receive BMS-986504; the study monitors how well it controls cancer and any side effects.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BMS-986504Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ankit Mangla, MD

Lead Sponsor

Citations

NCT07549022 | Safety and Efficacy of BMS-986504 in ...

The 5-year survival rate is about 50%. However, this drops to about 20% when the cancer has spread or cannot be removed with surgery.

Safety and Efficacy of BMS-986504 in Unresectable ...

Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor ... Download Trial Data.

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41568612/

A Canadian Sarcoma Research and Clinical Collaboration ...

Background: Malignant peripheral nerve sheath tumors (MPNSTs) are aggressive soft tissue sarcomas with a 5-year survival rate of approximately 50%, secondary to ...

A Phase 2 Study of BMS-986504 in People With Non-Small ...

BMS-986504 blocks PRMT5, an enzyme that plays a role in cancer cell growth. BMS-986504 blocks processes that promote growth in MTAP-deleted cancer cells, while ...

A Phase II Trial to Assess the Safety and Efficacy of BMS ...

A Phase II Trial to Assess the Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor Patients With ...

Clinical Trial of BMS-986504 in Recurrent GBM Patients

The trial will include a dose escalation design to evaluate the pharmacokinetics (PK) and safety and tolerability of BMS-986504 (MRTX1719). The ...