BMS-986504 + Chemotherapy for Pancreatic Cancer

Recruiting at 277 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Bristol-Myers Squibb

Must be taking: Nab-paclitaxel, Gemcitabine

Disqualifiers: Concurrent malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

470 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BMS-986504, to determine its safety and effectiveness when combined with standard chemotherapy drugs for pancreatic cancer. It targets individuals with untreated metastatic pancreatic ductal adenocarcinoma (PDAC) who have a specific genetic change called MTAP deletion. Participants will receive either the new drug with chemotherapy or a placebo with chemotherapy. This trial suits those who have not yet received treatment for their metastatic cancer and possess this genetic profile. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Previous studies have shown that BMS-986504 is well tolerated by patients. Most side effects were mild, with only 14% of patients experiencing moderate issues in studies on solid tumors. This suggests it is relatively safe for most people.

The combination of gemcitabine and nab-paclitaxel also treats pancreatic cancer. Research has shown it improves survival rates compared to using gemcitabine alone. Side effects can occur, but they are usually manageable. These drugs are widely used, which adds reassurance about their safety.

Overall, both BMS-986504 and the gemcitabine-nab-paclitaxel combination have demonstrated promising safety profiles in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BMS-986504 combined with chemotherapy for pancreatic cancer because it represents a new approach to treatment. Most current therapies, like gemcitabine and nab-paclitaxel, work by targeting rapidly dividing cancer cells. However, BMS-986504 introduces a novel mechanism that may enhance the immune system's ability to fight cancer. This combination has the potential to improve outcomes by not just attacking cancer cells directly but also by empowering the body's own defenses. This dual-action strategy could lead to more effective and longer-lasting results for patients.

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

This trial tests BMS-986504 in combination with chemotherapy for pancreatic cancer. Research has shown that BMS-986504, when combined with other treatments, might help treat certain cancers. In one study, BMS-986504 shrank or eliminated tumors in about 29% of patients with non-small cell lung cancer and a specific genetic deletion. Additionally, the combination of gemcitabine and nab-paclitaxel has been shown to extend life and slow disease progression in pancreatic cancer patients. This trial now tests these treatments together to determine their effectiveness against pancreatic cancer, particularly in those with a specific gene deletion. ^{1 2 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for individuals with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) that have a specific genetic change called homozygous MTAP deletion. Detailed eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

My cancer is a type of pancreatic cancer confirmed by lab tests.

I completed my first round of nab-p/gem chemotherapy for metastatic cancer before joining.

My cancer has a specific genetic change called MTAP deletion.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have any other cancers needing treatment or any cancer active in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986504 in combination with Nab-paclitaxel and Gemcitabine or placebo in combination with Nab-paclitaxel and Gemcitabine

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986504
• Gemcitabine
• Nab-paclitaxel

Trial Overview The study tests the safety and effectiveness of BMS-986504 combined with chemotherapy drugs Nab-paclitaxel and Gemcitabine versus a placebo combined with the same chemotherapy in patients with PDAC. The goal is to see if BMS-986504 improves treatment outcomes.

How Is the Trial Designed?

Group I: Arm E Experimental Treatment 3 Interventions

Group II: Arm B Experimental Treatment 3 Interventions

Group III: Arm A Experimental Treatment 3 Interventions

Group IV: Arm D Placebo Group 3 Interventions

Group V: Arm C Placebo Group 3 Interventions

Group VI: Arm F Placebo Group 3 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead 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/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 ...

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. 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 ...

6. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5849

A Study Comparing BMS-986504 in Combination With Nab ... The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/ ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40694535/

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

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-07031

A Study Comparing BMS-986504 in Combination With Nab ... The purpose of this study is to assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/ ...