BMS-986504 for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: CYP3A4 inhibitors, Proton-pump inhibitors

Disqualifiers: Other cancers, Cardiac abnormalities, Active infections, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, BMS-986504 (an experimental drug), can help control pancreatic cancer when combined with chemotherapy and, in some cases, surgery. Participants will be divided into groups to receive different treatment combinations, including standard chemotherapy options like gemcitabine and mFOLFIRINOX. The trial seeks participants with confirmed pancreatic cancer who have specific genetic markers (MTAP deletion) and have not undergone extensive previous treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BMS-986504, a new treatment, appears safe when combined with chemotherapy. In earlier studies, patients tolerated the treatment well, and it proved safe. BMS-986504 worked effectively with other treatments, indicating proper drug processing and expected performance.

While detailed safety data from this specific trial is not yet available, similar studies with BMS-986504 have not reported major safety issues. This suggests it might be well-tolerated by patients, but it's important to remember that all treatments can have side effects. Prospective participants should discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for pancreatic cancer?

Researchers are excited about BMS-986504 for pancreatic cancer due to its innovative approach. Unlike standard treatments like gemcitabine and nab-paclitaxel, BMS-986504 is being tested in combination with these drugs and others like mFOLFIRINOX, aiming to enhance their effectiveness. One of the unique aspects is its potential use as a maintenance therapy, allowing patients to continue treatment with BMS-986504 alone, which could help maintain the disease's stability. This flexibility and potential for prolonged effectiveness make it a promising option in battling this challenging cancer.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that BMS-986504 might help treat pancreatic cancer, especially when combined with chemotherapy. In this trial, participants in Cohorts 1 and 2 will receive a combination of BMS-986504, gemcitabine, and nab-paclitaxel, with Cohort 2 continuing with BMS-986504 alone as maintenance therapy. Participants in Cohort 3 will receive BMS-986504 combined with mFOLFIRINOX (oxaliplatin, irinotecan, and 5-fluorouracil). In other cancers, such as non-small cell lung cancer, BMS-986504 shrank or stopped tumor growth in 29% of cases. Evidence also suggests that BMS-986504 works well with other drugs for pancreatic cancer with certain genetic changes. This approach aims to improve outcomes by targeting cancer cells more precisely. These findings offer hope that BMS-986504 could help manage pancreatic cancer when combined with standard treatments. ^{1 4 5 6 7}

Who Is on the Research Team?

Maria P Morelli, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with MTAP-deleted pancreatic cancer. Participants should not have high blood pressure that could complicate treatment. Specific eligibility details are not provided, but typically include factors like age, overall health, and cancer stage.

Inclusion Criteria

Adequate organ and marrow function including: Hemoglobin ≥9.0 g/dL, ANC ≥1.5 x 10⁹/L, Platelet count ≥100 x 10⁹/L, Total bilirubin ≤1.5 x institutional upper limit of normal, AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN value unless liver metastases are present, Calculated creatinine clearance ≥50 mL/min

I have received 1 month of specific chemotherapy.

Agree to follow the study protocol, including treatment, scheduled visits, and examinations

Exclusion Criteria

I have not had major surgery in the last 2 weeks.

I have had significant fluid buildup in my body within the last month.

I haven't had cancer in the last 5 years, except for skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of BMS-986504 and chemotherapy for 4-6 months

4-6 months

Regular visits for chemotherapy administration

Maintenance Therapy

Participants receive BMS-986504 alone as maintenance therapy

As long as the disease does not progress

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986504

Trial Overview

The study tests BMS-986504 combined with chemotherapy (nab-paclitaxel or mFOLFIRINOX) and possibly surgery in one group, against BMS-986504 with standard chemotherapy (like Gemcitabine) in others to see which is better at controlling pancreatic cancer.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 2 Interventions

Will receive a combination of BMS-986504, and the combination treatment mFOLFIRINOX (oxaliplatin, irinotecan, and 5-fluorouracil) for 4-6 months.

Group II: Cohort 2 Experimental Treatment 3 Interventions

Will receive a combination of BMS-986504, gemcitabine, and nab-paclitaxel for 4-6 months, followed by Maintenance Therapy with BMS-986504 by itself for as long as the disease does not get worse.

Group III: Cohort 1 Experimental Treatment 3 Interventions

Will receive a combination of BMS-986504, gemcitabine, and nab-paclitaxel for 4 treatment cycles.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07283705

A Phase II Study Evaluating BMS-986504 in MTAP-deleted ...

Cohorts 2 and 3: To evaluate the safety, tolerability and efficacy of BMS-986504 in concomitant with SOC chemo and as maintenance therapy.

2.

news.bms.com

news.bms.com/news/details/2025/Bristol-Myers-Squibb-to-Present-Data-at-ASCO-2025-Highlighting-Differentiated-Research-Platform-of-Oncology-Treatments-and-Innovative-Research-Pipeline/default.aspx

Bristol Myers Squibb to Present Data at ASCO® 2025 ...

Data from more than 80 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning more than 20 cancer types. “ ...

3.

iaslc.org

iaslc.org/iaslc-news/press-release/bms-986504-demonstrates-durable-responses-mtap-deleted-nsclc-including

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.

aacrjournals.org

aacrjournals.org/cancerres/article/85/18/3540/764439/Combination-of-the-MTA-Cooperative-PRMT5-Inhibitor

Combination of the MTA-Cooperative PRMT5 Inhibitor BMS ...

Combination of the MTA-Cooperative PRMT5 Inhibitor BMS-986504 and KRAS Inhibitors Is an Effective Treatment Strategy for MTAP-Deleted KRAS-Mutant Pancreatic ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0305737225000957

Medical management of pancreatic cancer

Pancreatic ductal adenocarcinoma (PDAC) remains one of the leading causes of cancer-related mortality worldwide, with a five-year survival rate of only 11 %.[1] ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07076121

NCT07076121 | A Study Comparing BMS-986504 in ...

The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with ...

7.

sigma.larvol.com

sigma.larvol.com/product.php?e1=958597&tab=newstrac

BMS‐986504 News

BMS-986504 demonstrated a favorable PK/PD profile, supporting QD dosing at 400 and 600 mg. These results support further investigation of BMS-986504 at 400 and ...