260 Participants NeededMy employer runs this trial

BMS-986504 for Cancer

Recruiting at 77 trial locations
BC
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BMS-986504, for individuals with advanced solid tumors that have a specific gene deletion called MTAP. Researchers aim to determine if BMS-986504, an experimental treatment, is safe and effective when used alone or with other cancer treatments. Individuals with a confirmed diagnosis of this cancer type who have not responded to standard treatments might be suitable candidates. Those with a measurable tumor and no active brain metastases may qualify for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from a potentially effective new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have prior treatment with certain inhibitors and must be stable without certain medications for brain metastases. It's best to discuss your specific medications with the trial team.

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

Research has shown that BMS-986504, whether used alone or with other treatments, is generally safe. In earlier studies, participants tolerated BMS-986504 well, with most side effects being mild or moderate. For those using BMS-986504 with Pumitamig and chemotherapy, the safety was manageable, and no new safety issues emerged.

When combined with a Pan-RAS inhibitor, BMS-986504 effectively fought tumors and was well-tolerated. The combination of BMS-986504 with Nivolumab and Relatlimab showed a safety profile consistent with expectations for these treatments. Lastly, using BMS-986504 with Temozolomide and radiotherapy improved treatment effects and quality of life, with manageable side effects.

Overall, these findings suggest that BMS-986504, in various combinations, is generally safe, with side effects that are mostly mild or moderate.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment BMS-986504 for cancer because it offers a unique approach compared to standard therapies like chemotherapy and targeted therapies. Unlike traditional treatments, which often attack cancer cells non-selectively, BMS-986504 is being tested in combination with specific agents like Pumitamig and Pan-RAS inhibitors. This combination targets cancer growth pathways more precisely, potentially reducing harmful side effects. Additionally, some arms of the trial are exploring the combination of BMS-986504 with immunotherapy agents like Nivolumab and Relatlimab, which could enhance the body's immune response to cancer. These innovative combinations might lead to more effective and personalized treatment options for patients with challenging cancer types.

What evidence suggests that this trial's treatments could be effective for advanced and/or metastatic solid tumors with MTAP deletion?

Research has shown promising results for the treatments tested in this trial. Participants in Part 2: Cohort 1 will receive BMS-986504 combined with pumitamig and chemotherapy. Studies indicate that more than half of the patients experienced tumor shrinkage, with a 61.5% response rate in some cancer types. In Part 2: Cohorts 2a, 2b, and 2c, participants will receive BMS-986504 with a Pan-RAS inhibitor, with or without chemotherapy, showing a 29% response rate in certain patients and strong anti-tumor effects in early lab studies. Part 2: Cohort 3 involves BMS-986504 with nivolumab and relatlimab, which showed positive results in treating melanoma, a type of skin cancer. Lastly, participants in Part 2: Cohort 4 will receive BMS-986504 combined with temozolomide and radiotherapy, which improved survival rates in brain cancer trials. Overall, these findings are encouraging for treating cancers with specific genetic traits.26789

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (like brain, melanoma, pancreatic cancer) that have a specific MTAP gene deletion. Participants must have tried standard treatments or be unable to receive them, and need at least one measurable tumor. Good general health and organ function are required; certain infections or untreated brain metastases exclude participation.

Inclusion Criteria

I have advanced cancer with a confirmed MTAP gene deletion in my tumor.
I have advanced cancer and either my disease got worse after standard treatments or I have not had any treatment yet.
Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline
See 2 more

Exclusion Criteria

I do not have active hepatitis B or C.
I do not have untreated or active cancer in my brain or meninges.
I have never been treated with a PRMT5 or MAT2A inhibitor.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1

Participants receive BMS-986504 as monotherapy in tumor-specific dose-expansion cohorts

Up to approximately 2 years

Treatment - Part 2

Participants receive BMS-986504 in combination with other anticancer agents in dose-escalation cohorts

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Daraxonrasib
  • Gemcitabine
  • Nab-paclitaxel
  • Nivolumab + Relatlimab FDC
  • Paclitaxel
  • Pemetrexed
  • Pumitamig
  • Temozolomide

Trial Overview

The study tests BMS-986504 alone and in combination with other anti-cancer drugs (such as Nivolumab/Relatlimab FDC, Temozolomide, Pemetrexed, Carboplatin). It aims to find out how safe these treatments are and if they help shrink tumors in people with MTAP-deleted cancers.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Group I: Part 2: Cohort 4Experimental Treatment2 Interventions
Group II: Part 2: Cohort 3Experimental Treatment2 Interventions
Group III: Part 2: Cohort 2cExperimental Treatment4 Interventions
Group IV: Part 2: Cohort 2bExperimental Treatment2 Interventions
Group V: Part 2: Cohort 2aExperimental Treatment2 Interventions
Group VI: Part 2: Cohort 1Experimental Treatment6 Interventions
Group VII: Part 1bExperimental Treatment1 Intervention
Group VIII: Part 1aExperimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41109920/

Adjuvant nivolumab and relatlimab in stage III/IV melanoma

Based on RELATIVITY-047, nivolumab plus relatlimab is approved for advanced melanoma. Here, to address a current unmet need for more ...

NCT07492680 | A Study of BMS-986504 Monotherapy and ...

This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that ...

Four-Year Outcomes Highlight Efficacy of Neoadjuvant ...

A neoadjuvant and adjuvant regimen of anti–PD-1 therapy with nivolumab and anti–LAG-3 therapy with relatlimab led to a 4-year event-free survival rate of 80% ...

A Study To Assess the Safety, and Tolerability of Nivolumab + ...

The purpose of this study is to assess the safety and tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) in untreated, ...

Efficacy | Opdualag® (nivolumab and relatlimab-rmbw) for HCPs

All data shown below is 4-year data based on minimum potential follow-up of 45.3 months.2. Overall survival at 4 years ( ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40716631/

Safety profile of nivolumab-relatlimab in cancer patients

Disproportionality analyses of FAERS pharmacovigilance data identified 39 positive signals, with 18 AEs not mentioned in the drug label.

A Study of BMS-986504 Monotherapy and in Combination ...

The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and ...

761234Orig1s000 - accessdata.fda.gov

relatlimab FDC. Overall, the safety profile for nivolumab-relatlimab FDC in Study CA224047 is consistent with the types of AEs expected for ...

NCT07077434 | A Study to Assess Safety, Tolerability and ...

The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986504 in participants with advanced solid tumors. ... Plan to Share ...