Malignant Peripheral Nerve Sheath Tumors study: BMS-986504
Official title Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor
ClinicalTrials.gov ID: NCT07549022
What this study is testing
What is BMS-986504?
This is an investigational oral medicine being studied as a potential treatment for Malignant Peripheral Nerve Sheath Tumors (MPNST).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if BMS‑986504 is safe and works for patients with MPNST who have MTAP loss.
- Who it's for
- Adults with malignant peripheral nerve sheath tumors that have a missing MTAP gene.
- What's involved
- Participants will receive the drug BMS‑986504 and attend scheduled visits and tests to monitor safety and effectiveness.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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).
- 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.
- Creatinine \< 1.5 times institutional ULN for age.
- 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.
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.