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BMS-986504 for Unresectable Malignant Peripheral Nerve Sheath Tumor

This study is for people with Malignant Peripheral Nerve Sheath Tumors (MPNST), a type of cancer that grows in soft tissues and cannot be removed by surgery. Researchers are testing a drug called BMS-986504 to see if it can help treat MPNST. This drug is taken by mouth. The study is looking for people whose tumors are missing a specific gene called MTAP, as this might make the drug more effective. The main goal is to see how many participants' tumors shrink or stop growing (Objective Response Rate) over a period of up to two years. The study plans to enroll 17 participants aged 12 and older. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 17 participants.
What's involved
Participants will take 600 mg of BMS-986504 by mouth daily for 28 days in each 28-day cycle. Treatment will continue for up to two years, or until the disease gets worse, side effects are too severe, or you choose to stop.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study, Objective Response Rate, will be measured for up to two years.

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NCT07549022

Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor

Recruiting
PHASE1Ages 12+InterventionalTreatment
Ankit Mangla, MD
~17 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:BMS-986504

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Up to 2 years

Conditions

Malignant Peripheral Nerve Sheath Tumors
MPNST

Explore related trials

Malignant Peripheral Nerve Sheath TumorMTAP Gene

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Ankit Mangla, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, University Hospitals

Who to contact

Ankit Mangla, MD
[email protected]
216-844-6031
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female participants ≥ 12 years of age at the time of screening.
Ability to understand and willingness to sign documentation of informed consent if ≥ 18 years of age or documentation of assent if 12-17 years of age.
Pathohistological verification of MPNST.
Measurable disease (size of primary tumor and metastatic lesions can be trended by CT or MRI scans).
Unresectable (locally advanced or metastatic) disease.
Confirmation of homozygous MTAP deletion by next generation sequencing
Recovery from the adverse effects of prior therapy at the time of enrollment to baseline or ≤ Grade 1 (excluding alopecia, peripheral neuropathy, and parameters superseded by other eligibility criteria \[eg, hematology parameters\]). Note: Participants with prior endocrine adverse effects are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
Recovery from the acute toxic effects (≤ grade 1 as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0) of all prior chemotherapy prior to the entering study (exceptions: alopecia, anorexia, mass pain).
Normal marrow function and recovery of blood cell counts from any myelosuppressive chemotherapy prior to entering study:
Peripheral absolute neutrophil count (ANC) ≥ 1500/mcL (microliter).
Hemoglobin ≥ 9 g/dL (packed red blood cell transfusion is not allowed up to 14 days prior to starting BMS-986504 treatment to meet eligibility).
Platelet count ≥ 100,000/mcL (microliter) (platelet transfusion is not allowed up to 14 days prior to starting BMS-986504 treatment to meet eligibility).
Adequate organ function, including:
Liver function:
Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for age, or ≤ 3 x ULN if associated with liver metastatic disease or Gilbert's disease).
ALT (alanine transaminase) and AST (aspartate aminotransferase) \< 3 x ULN for age, or \< 5 x ULN if associated with liver metastatic disease.
Serum albumin ≥ 2.0 g/dL.
PT (prothrombin time) and/or INR (International Normalized Ratio) ≤ 1.5 x ULN, or within therapeutic range if receiving anticoagulant therapy.
Renal function:
Creatinine \< 1.5 times institutional ULN for age.
Performance status at time of screening:
ECOG (Eastern Cooperative Oncology Group) performance status 0-1 for participants ≥ 18 years old.
Lansky performance status (ages 12-15) or Karnofsky performance status (ages 16-17) ≥ 50.
Individuals of childbearing potential (IOCBP) must practice effective contraception during the trial.

Exclusion

Participants who have been treated previously with a PRMT5 inhibitor.
Participants who are unable to swallow tablets.
History of gastrointestinal disease, inflammatory bowel disease, major gastric surgery or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
Participants with active drug use.
Any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study received within 4 weeks prior to randomization. The concurrent use of any botanical preparation is not permitted while on study.
Ongoing need for a medication known as a strong inhibitor or strong inducer of CYP3A4 and/or P-gp or a PPI (proton pump inhibitor) that cannot be switched to an alternative treatment prior to randomization.

What this trial measures

  • Objective response rate (ORR)Up to 2 years

    ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions.