BMS-986504 + Pembrolizumab + Chemotherapy for Lung Cancer

(MountainTAP-29 Trial)

Recruiting at 250 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

Disqualifiers: Brain metastases, Spinal cord compression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

590 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for individuals with metastatic non-small cell lung cancer (NSCLC). The researchers aim to determine if adding the experimental drug BMS-986504 to the standard treatment of pembrolizumab and chemotherapy is more effective than the standard treatment alone. The trial seeks participants diagnosed with NSCLC who have a specific genetic marker called MTAP deletion. Those who have not yet received treatment for metastatic lung cancer and meet the genetic criteria may be suitable for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, contributing to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

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

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

Earlier studies found that BMS-986504 was well tolerated by patients with various advanced cancers. Researchers observed manageable side effects and promising tumor-fighting results. Although specific side effects are not listed here, the overall tolerance indicates a positive safety profile.

Pembrolizumab, another treatment in this trial, has already received FDA approval for several cancer types. This approval suggests general safety, though side effects can occur, as with any treatment. The study combines these treatments to maximize results while managing risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BMS-986504 combined with Pembrolizumab and chemotherapy for lung cancer because it offers a novel approach to treatment. Most current treatments target specific proteins on cancer cells, but BMS-986504 is designed to enhance the immune system's own ability to fight cancer by modulating immune checkpoints. This unique mechanism could potentially lead to more effective and longer-lasting responses against lung cancer compared to traditional therapies. Additionally, combining it with Pembrolizumab, an established immunotherapy, could enhance overall treatment efficacy, offering renewed hope for patients battling this tough condition.

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

In this trial, some participants will receive a combination of BMS-986504, pembrolizumab, and chemotherapy. Research has shown this combination may effectively treat lung cancer in patients with a specific genetic change called MTAP deletion. BMS-986504 blocks a protein complex that helps cancer cells survive, leading to their death. Previous patients experienced lasting benefits, with the treatment shrinking or controlling their tumors over time. Pembrolizumab is known for boosting the immune system's ability to fight cancer, potentially enhancing the combination's effectiveness. This treatment aims to improve outcomes for people with advanced non-small cell lung cancer. Other participants will receive a placebo with pembrolizumab and chemotherapy to compare the investigational treatment's effectiveness. ^{1 3 4 6 7}

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 adults with metastatic non-small cell lung cancer who have a specific genetic change called homozygous MTAP deletion. They should not have had treatment for their cancer before.

Inclusion Criteria

Participants must have at least 1 measurable lesion as per RECIST v1.1

I have stage IV or recurrent NSCLC and haven't had systemic therapy for it.

My lung cancer is confirmed and lacks a specific gene.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

My nonsquamous cancer lacks specific genetic changes treatable by standard therapies.

I do not have symptoms from brain or spinal cord cancer spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986504 or placebo in combination with pembrolizumab and chemotherapy

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986504
• Pembrolizumab

Trial Overview The study tests BMS-986504 (a new drug) combined with pembrolizumab and chemotherapy against a placebo plus pembrolizumab and chemotherapy to see which is better for this type of lung cancer.

How Is the Trial Designed?

Group I: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy Active Control 7 Interventions

Group II: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy Active Control 7 Interventions

Group III: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy Active Control 7 Interventions

Group IV: Arm F: Placebo + Pembrolizumab + Chemotherapy Placebo Group 7 Interventions

Group V: Arm D: Placebo + Pembrolizumab + Chemotherapy Placebo Group 7 Interventions

Group VI: Arm C: Placebo + Pembrolizumab + Chemotherapy Placebo Group 7 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/NCT07063745

NCT07063745 | A Study to Compare the Combination of ... The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus ...

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

BMS-986504 Demonstrates Durable Responses in MTAP- ... BMS-986504 is designed to selectively target and inhibit PRMT5 when it's bound to MTA (PRMT5-MTA complex), leading to cell death in MTAP-deleted ...

3. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT07063745

Trial ID CA240-0029 | NCT07063745 - BMS Clinical Trials The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus ...

4. bmsstudyconnect.com bmsstudyconnect.com/dk/en/health-studies/lung-cancer-clinical-trials.html

Lung Cancer Clinical Trials | BMS Study Connect A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2025-06074

A Study to Compare the Combination of BMS-986504 With ... A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3011

BMS-986504 in patients (pts) with advanced solid tumors ... BMS-986504 was found to be well tolerated and demonstrated antitumor activity in multiple tumors. Here, we report clinical results and the first PK and PD ...

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

BMS‐986504 News Our ongoing studies are evaluating the consequences of co-targeting PRMT5 and KRAS on gene expression changes using RNA-Seq and cancer cell signaling pathways ...