Malignant Peripheral Nerve Sheath TumorsPhase 1/2NCT07549022
Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor
A Phase 1/2 study testing BMS-986504 in people with Malignant Peripheral Nerve Sheath Tumors and MPNST, run by Ankit Mangla, MD at 1 site in United States.
Trial summary
People who have a cancer called MPNST, or Malignant Peripheral Nerve Sheath Tumor, may be eligible for this study. The purpose of this study is to see if a new medicine called BMS-986504 may work better than other available medicines for people with MPNST. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Malignant Peripheral Nerve Sheath Tumors, MPNST
- What is being tested?
- BMS-986504
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 24Show fewer
- 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therapy at the time of enrollment to baseline or ≤ Grade 1 (excluding alopecia, peripheral neuropathy, and parameters superseded by other eligibility criteria [eg, hematology parameters]).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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Ankit Mangla, MD, 216-844-6031, ankit.mangla@uhhospitals.org
Ankit Mangla, MD
About this study
Official title: A Phase II Trial to Assess the Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor Patients With Homozygous MTAP Deletion
People who have a cancer called MPNST, or Malignant Peripheral Nerve Sheath Tumor, may be eligible for this study. The purpose of this study is to see if a new medicine called BMS-986504 may work better than other available medicines for people with MPNST. Methylthioadenosine Phosphorylase (MTAP) loss is a gene mutation that some people have. MTAP loss seems to increase the chance that BMS-986504 can kill MPNST cancer cells. People who are missing MTAP from their tumor may be able to enroll in this study. Treating MPNST based on MTAP loss is considered experimental and is not approved by the US Food and Drug Administration (FDA) for determining whether BMS-98650 will be active against cancer. The purpose of this study is to evaluate the safety and effectiveness of BMS-986504 in participants with MPNST.
Read the detailed description
Malignant Peripheral Nerve Sheath Tumors (MPNSTs) are fast-growing, aggressive cancers that develop in soft tissues. They are the main cause of serious illness and death in people with neurofibromatosis type 1 (NF1), a condition that increases the risk of cancer. MPNSTs are rare, affecting about 1 in 100,000 people. In the United States, about 800 to 1,000 new cases are diagnosed each year. 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. Chemotherapy is often less effective, especially when the tumor cannot be removed by surgery, with response rates under 20%. There is a strong need to develop new and more targeted therapies for this type of cancer.
When some benign (non-cancerous) nerve tumors, called neurofibromas, turn into MPNST, it is often caused by the loss of a group of genes called CDKN2A on chromosome 9. These genes normally help prevent tumors from forming. When a part of chromosome 9 called 9p21 is deleted, it can also cause the loss of a nearby gene called MTAP. MTAP is missing in about 25-50% of people with MPNST. MTAP plays an important role in the methionine salvage pathway and serves a critical role in methylation reactions. When MTAP is lost, cells have problems with purine metabolism and become more dependent on another pathway, the arginine methylation pathways. This pathway is important for processes like DNA repair and control of the cell cycle. An enzyme called protein arginine methyltransferase 5 (PRMT5) helps carry out arginine methylation by adding small chemical groups (methyl groups) to proteins. When both copies of the MTAP gene are lost (called homozygous deletion), cells rely even more on PRMT5 to survive. At the same time, a substance called methylthioadenosine builds up and partly blocks PRMT5 activity. Because of this, completely blocking PRMT5 can cause MTAP-deficient cancer cells to die, a concept known as "synthetic lethality." For people with MPNST who have homozygous MTAP deletion confirmed by next-generation sequencing (NGS), drugs that block PRMT5 may help shrink tumors. A drug called BMS-986504 is a first-in-class PRMT5 inhibitor designed to specifically target MTAP-deficient tumor cells by binding to the PRMT5-MTA complex.
BMS-986504 was recently studied in a Phase 1 trial and showed evidence of anti-tumor activity. People with tumors that could not be removed with surgery with a homozygous MTAP deletion and whose disease had gotten worse since their last treatment were given varying doses of BMS-986504. Three of the 6 people enrolled had disease progression. The remaining 3 participants had partial responses, meaning that there was a >30% improvement from their baseline per RECIST v1.1 criteria. Each of these 3 participants had different doses of the study drug, which suggests a dose-independent response.
Since the current treatments for MPNST that cannot be removed through surgery are poor, it is important to identify new treatment strategies that may improve how long someone lives with this type of cancer and their health outcomes. This study aims to assess the safety and efficacy of BMS-986504 in people with MPNST that cannot be removed with surgery and with homozygous MTAP deletion.
- Conditions
- Malignant Peripheral Nerve Sheath Tumors, MPNST
- Being tested
- BMS-986504
- Keywords
- BMS-986504
- Medical subject headings
- Neurofibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986504Drug
Participants will receive 600 milligrams (mg) of BMS-986504 taken orally (by mouth) on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent (up to 2 years). Participants who experience dose-limiting toxicity can be transitioned to 400 mg daily, then 200 mg daily of BMS-986504, or taken off the clinical trial.
Nine participants will be enrolled in stage 1. If ≥ 1 participant demonstrates a complete or partial response in stage 1, the trial will proceed to stage 2, where an additional eight participants will be enrolled. If there are no responses or significant safety concerns arise, the trial will be halted.
| Study group | Role | What they receive |
|---|---|---|
| BMS-986504 | Experimental | Participants will receive BMS-986504 on Days 1-28 of each cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent. Receives: Drug: BMS-986504 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
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.
Measured: Up to 2 years
Secondary outcomes (4)
Progression free survival (PFS)
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: Up to 2 years
Overall survival (OS)
OS is defined as the time from treatment initiation to death from any cause.
Measured: Up to 2 years
Incidence of adverse events (AEs)
AEs will be defined and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: 30 days post-treatment discontinuation (up to 2 years)
Rate of treatment discontinuation
Proportion of participants discontinuing treatment due to toxicity will be calculated.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Malignant Peripheral Nerve Sheath TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankit Mangla, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ankit Mangla, MD, Case Comprehensive Cancer Center
- Investigators
- Ankit Mangla, MD, Principal investigator, Case Comprehensive Cancer Center, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549022
- Sponsor's protocol ID
- CASE3725
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller DT, Freedenberg D, Schorry E, Ullrich NJ, Viskochil D, Korf BR; COUNCIL ON GENETICS; AMERICAN COLLEGE OF MEDICAL GENETICS AND GENOMICS. Health Supervision for Children With Neurofibromatosis Type 1. Pediatrics. 2019 May;143(5):e20190660. doi: 10.1542/peds.2019-0660.
PubMed 31010905Kolb, S., et al. (2021). The Role of Radiation Therapy in the Treatment of Malignant Peripheral Nerve Sheath Tumors. Journal of Clinical Oncology. 39(25): 2762-2773. doi:10.1200/JCO.21.01232.
Montoya, P., et al. (2023). Methylthioadenosine Phosphorylase Deficiency in MPNST: Implications for Targeted Therapies. Neuro-Oncology. 25(S5): v238. doi:10.1093/neuonc/noad243.
Zhang, Y., et al. (2021). Loss of MTAP in cancer cells drives metabolic dependency on the arginine methylation pathway. Cancer Research. 81(13): 3538-3549. doi: 10.1158/0008-5472.CAN-21-0766.
Turner, J., et al. (2022). Targeting methylthioadenosine phosphorylase and arginine methylation for synthetic lethality in MTAP-deficient cancers. Nature Communications. 13(1): 1167. doi: 10.1038/s41467-022-29032-2.
Chang, L., et al. (2021). Protein arginine methyltransferase 5 inhibitors as therapeutic agents for cancer. Journal of Medicinal Chemistry.
Liu, W., et al. (2023). PRMT5 inhibition as a therapeutic strategy for MTAP-deficient cancers. Clinical Cancer Research. 29(3): 721-731. doi:10.1158/1078-0432.CCR-22-2479.
Walker, L., et al. (2023). Targeting PRMT5 in MTAP-deleted cancers: A synthetic lethal approach. Journal of Clinical Oncology. 41(4): 157-167. doi:10.1200/JCO.22.00399.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Assess the Safety and Efficacy of BMS-986504 in Unresectable Malignant Peripheral Nerve Sheath Tumor Patients With Homozygous MTAP Deletion
- ClinicalTrials.gov ID
- NCT07549022
- Acronym / sponsor ID
- CASE3725
- Conditions
- Malignant Peripheral Nerve Sheath Tumors, MPNST
- Keywords
- BMS-986504
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Ankit Mangla, MDUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who have a cancer called MPNST, or Malignant Peripheral Nerve Sheath Tumor, may be eligible for this study. The purpose of this study is to see if a new medicine called BMS-986504 may work better than other available medicines for people with MPNST. Methylthioadenosine Phosphorylase (MTAP) loss is a gene mutation that some people have. MTAP loss seems to increase the chance that BMS-986504 can kill MPNST cancer cells. People who are missing MTAP from their tumor may be able to enroll in this study. Treating MPNST based on MTAP loss is considered experimental and is not approved by the US Food and Drug Administration (FDA) for determining whether BMS-98650 will be active against cancer. The purpose of this study is to evaluate the safety and effectiveness of BMS-986504 in participants with MPNST.
Detailed description
Malignant Peripheral Nerve Sheath Tumors (MPNSTs) are fast-growing, aggressive cancers that develop in soft tissues. They are the main cause of serious illness and death in people with neurofibromatosis type 1 (NF1), a condition that increases the risk of cancer. MPNSTs are rare, affecting about 1 in 100,000 people. In the United States, about 800 to 1,000 new cases are diagnosed each year. 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. Chemotherapy is often less effective, especially when the tumor cannot be removed by surgery, with response rates under 20%. There is a strong need to develop new and more targeted therapies for this type of cancer.
When some benign (non-cancerous) nerve tumors, called neurofibromas, turn into MPNST, it is often caused by the loss of a group of genes called CDKN2A on chromosome 9. These genes normally help prevent tumors from forming. When a part of chromosome 9 called 9p21 is deleted, it can also cause the loss of a nearby gene called MTAP. MTAP is missing in about 25-50% of people with MPNST. MTAP plays an important role in the methionine salvage pathway and serves a critical role in methylation reactions. When MTAP is lost, cells have problems with purine metabolism and become more dependent on another pathway, the arginine methylation pathways. This pathway is important for processes like DNA repair and control of the cell cycle. An enzyme called protein arginine methyltransferase 5 (PRMT5) helps carry out arginine methylation by adding small chemical groups (methyl groups) to proteins. When both copies of the MTAP gene are lost (called homozygous deletion), cells rely even more on PRMT5 to survive. At the same time, a substance called methylthioadenosine builds up and partly blocks PRMT5 activity. Because of this, completely blocking PRMT5 can cause MTAP-deficient cancer cells to die, a concept known as "synthetic lethality." For people with MPNST who have homozygous MTAP deletion confirmed by next-generation sequencing (NGS), drugs that block PRMT5 may help shrink tumors. A drug called BMS-986504 is a first-in-class PRMT5 inhibitor designed to specifically target MTAP-deficient tumor cells by binding to the PRMT5-MTA complex.
BMS-986504 was recently studied in a Phase 1 trial and showed evidence of anti-tumor activity. People with tumors that could not be removed with surgery with a homozygous MTAP deletion and whose disease had gotten worse since their last treatment were given varying doses of BMS-986504. Three of the 6 people enrolled had disease progression. The remaining 3 participants had partial responses, meaning that there was a >30% improvement from their baseline per RECIST v1.1 criteria. Each of these 3 participants had different doses of the study drug, which suggests a dose-independent response.
Since the current treatments for MPNST that cannot be removed through surgery are poor, it is important to identify new treatment strategies that may improve how long someone lives with this type of cancer and their health outcomes. This study aims to assess the safety and efficacy of BMS-986504 in people with MPNST that cannot be removed with surgery and with homozygous MTAP deletion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986504 | Experimental | Drug: BMS-986504Participants will receive BMS-986504 on Days 1-28 of each cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986504Participants will receive 600 milligrams (mg) of BMS-986504 taken orally (by mouth) on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent (up to 2 years). Participants who experience dose-limiting toxicity can be transitioned to 400 mg daily, then 200 mg daily of BMS-986504, or taken off the clinical trial. Nine participants will be enrolled in stage 1. If ≥ 1 participant demonstrates a complete or partial response in stage 1, the trial will proceed to stage 2, where an additional eight participants will be enrolled. If there are no responses or significant safety concerns arise, the trial will be halted. | Drug | BMS-986504 |
Primary outcome
Objective response rate (ORR)
Time frame: 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.
4 secondary outcomes
Progression free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Incidence of adverse events (AEs)
Time frame: 30 days post-treatment discontinuation (up to 2 years)
Rate of treatment discontinuation
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 31010905Miller DT, Freedenberg D, Schorry E, Ullrich NJ, Viskochil D, Korf BR; COUNCIL ON GENETICS; AMERICAN COLLEGE OF MEDICAL GENETICS AND GENOMICS. Health Supervision for Children With Neurofibromatosis Type 1. Pediatrics. 2019 May;143(5):e20190660. doi: 10.1542/peds.2019-0660.
- BackgroundKolb, S., et al. (2021). The Role of Radiation Therapy in the Treatment of Malignant Peripheral Nerve Sheath Tumors. Journal of Clinical Oncology. 39(25): 2762-2773. doi:10.1200/JCO.21.01232.
- BackgroundMontoya, P., et al. (2023). Methylthioadenosine Phosphorylase Deficiency in MPNST: Implications for Targeted Therapies. Neuro-Oncology. 25(S5): v238. doi:10.1093/neuonc/noad243.
- BackgroundZhang, Y., et al. (2021). Loss of MTAP in cancer cells drives metabolic dependency on the arginine methylation pathway. Cancer Research. 81(13): 3538-3549. doi: 10.1158/0008-5472.CAN-21-0766.
- BackgroundTurner, J., et al. (2022). Targeting methylthioadenosine phosphorylase and arginine methylation for synthetic lethality in MTAP-deficient cancers. Nature Communications. 13(1): 1167. doi: 10.1038/s41467-022-29032-2.
- BackgroundChang, L., et al. (2021). Protein arginine methyltransferase 5 inhibitors as therapeutic agents for cancer. Journal of Medicinal Chemistry.
- BackgroundLiu, W., et al. (2023). PRMT5 inhibition as a therapeutic strategy for MTAP-deficient cancers. Clinical Cancer Research. 29(3): 721-731. doi:10.1158/1078-0432.CCR-22-2479.
- BackgroundWalker, L., et al. (2023). Targeting PRMT5 in MTAP-deleted cancers: A synthetic lethal approach. Journal of Clinical Oncology. 41(4): 157-167. doi:10.1200/JCO.22.00399.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ankit Mangla, MD principal investigator
Case Comprehensive Cancer Center, University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986504 in people with Malignant Peripheral Nerve Sheath Tumors and MPNST, run by Ankit Mangla, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ankit Mangla, MD (216-844-6031, ankit.mangla@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549022, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.