A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer

NCT07532902 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 26-037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

The researchers are doing this study to test the safety of BMS-986504 in combination with standard disease-specific anticancer medication in people with metastatic/advanced unresectable MTAP-deleted solid tumor cancer.

Conditions

Diffuse Pleural Mesothelioma; Gastroesophageal Carcinoma; Urothelial Carcinoma

Keywords

BMS-986504; Metastatic MTAP-deleted Solid Tumors; Ipilimumab; Nivolumab; 5-fluorouracil; Leucovorin; Oxaliplatin; Gemcitabine; Carboplatin; Cisplatin

Outcome Measures

Primary Outcomes (1)

• determine a recommended phase II dose (RP2D) of BMS-986504 in combination with standard-of-care therapy

  The Common Terminology Criteria for Adverse Events (CTCAE) 5.0 will be used to determine all adverse events and dose-limiting toxicities.

  2 years

Secondary Outcomes (2)

• Overall Response Rate (ORR)

  2 years

• Progression-free survival (PFS)

  2 years

Study Arms (3)

Diffuse pleural mesothelioma (DPM): first-line treatment

EXPERIMENTAL

Participants will receive BMS-986504 + ipilimumab and nivolumab.

Drug: BMS-986504; Drug: Ipilimumab; Drug: Nivolumab

Gastroesophageal carcinoma (GEC): first-line treatment

EXPERIMENTAL

Participants will receive BMS-986504 + FOLFOX and nivolumab.

Drug: BMS-986504; Drug: Nivolumab; Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin

Urothelial carcinoma (UC): second- or third-line treatment

EXPERIMENTAL

Participants will receive either BMS-986504 + gemcitabine and carboplatin or BMS-986504 + gemcitabine and cisplatin. After that, BMS-986504 monotherapy is continued.

Drug: BMS-986504; Drug: Gemcitabine; Drug: Platinum

Interventions

BMS-986504 DRUG

BMS-986504 PO daily

Diffuse pleural mesothelioma (DPM): first-line treatment; Gastroesophageal carcinoma (GEC): first-line treatment; Urothelial carcinoma (UC): second- or third-line treatment

Ipilimumab DRUG

Ipilimumab (1mg/kg Q6wk)

Diffuse pleural mesothelioma (DPM): first-line treatment

Nivolumab DRUG

Nivolumab (360mg flat dose Q3wk)

Diffuse pleural mesothelioma (DPM): first-line treatment; Gastroesophageal carcinoma (GEC): first-line treatment

5-FU DRUG

are continued until disease progression or intolerance

Gastroesophageal carcinoma (GEC): first-line treatment

Leucovorin DRUG

are continued until disease progression or intolerance

Gastroesophageal carcinoma (GEC): first-line treatment

Oxaliplatin DRUG

are continued until disease progression or intolerance

Gastroesophageal carcinoma (GEC): first-line treatment

Gemcitabine DRUG

Gemcitabine are given for a maximum of 6 cycles

Urothelial carcinoma (UC): second- or third-line treatment

Platinum DRUG

Platinum are given for a maximum of 6 cycles

Urothelial carcinoma (UC): second- or third-line treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documentation of Disease:
• Patients must have pathologic confirmation of one of three diseases:
• Diffuse pleural mesothelioma (DPM)
• Gastroesophageal carcinoma (GEC) including adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
• PD-L1 CPS ≥1 (using clone 73-10, DAKO)
• HER2 overexpression negative (using clone 4B5, Ventana): HER2 IHC 0-1+, or HER2 2+ with ISH showing HER2:CEP17 ratio \<2 and average HER2 copy number \<6.0 signals/cell
• Urothelial carcinoma (UC)
• Archival tissue is acceptable
• Metastatic or advanced/unresectable disease:
• For Diffuse Pleural Mesothelioma (DPM) and Gastroesophageal Carcinoma (GEC )cohorts: no prior systemic treatment for metastatic disease
• Patients with metastatic disease after treatment for localized GEC may have received prior systemic therapy (chemotherapy and/or chemoradiation) if \>6 months have elapsed between the end of therapy and registration.
• One prior cycle of standard-of-care therapy alone without BMS-986504 or other MTAP inhibitors (ipi/nivo for DPM, FOLFOX + nivo for GEC) is acceptable with PI approval.
• For UC cohort: must have received at least 1 prior line of treatment without prior gemcitabine (prior tx with Gem+Platinum in the perioperative setting is permitted if at least 12 months have elapsed from trial enrollment)
• Patients with recurrent disease within 1 year of completion of prior perioperative systemic therapy are eligible with PI approval.
• One prior cycle of standard-of-care therapy alone with gemcitabine + platinum, without BMS-986504 or other MTAP inhibitors, is acceptable with PI approval.

You may not qualify if:

• Prior treatment with PRMT5i or MAT2Ai
• Symptomatic CNS metastases
• Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression and the patient is on a stable dose of corticosteroids
• Received palliative radiation therapy within 3 days prior to initiation of study treatment or definitive SRS including CNS SRS within 14 days prior to initiation of study treatment
• Patients who have had major surgery within 3 weeks of start of study drug
• o Note: procedures such as biopsy, pleural catheter insertion, central venous catheter or other minor procedures are permitted
• Any of the following cardiac abnormalities:
• Unstable angina pectoris or myocardial infarction within 6 months prior to enrollment
• Congestive heart failure ≥ NYHA Class 3 within 6 months prior to enrollment
• Prolonged QTc \> 500 milliseconds or history of Long QT Syndrome
• Child-Pugh class C liver cirrhosis
• Ongoing medical illness not otherwise listed which would preclude study at the discretion of the PI
• Inability to take medications PO (BMS-986504 cannot be taken via gastrostomy tube), refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, or any other condition that significantly affects gut motility or absorption and would preclude adequate absorption of BMS-986504 in the opinion of the treating physician and/or PI
• Ongoing need for a medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) or proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry
• HIV, HBV, or HCV with detectable viral load

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Ipilimumab; Nivolumab; Fluorouracil; Leucovorin; Oxaliplatin; Gemcitabine; Platinum

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Michael Offin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Offin, MD

CONTACT

646-608-3763; offinm@mskcc.org

Steven Maron, MD

CONTACT

646-888-6780

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single institution, phase 1a/1b basket study to assess safety and preliminary efficacy of the novel combination of BMS-986504 and standard-of-care therapy in patients with one of three solid tumors harboring an MTAP deletion (defined as homozygous MTAP deletion (NGS) or MTAP loss (IHC protein loss)

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)