BMS-986442 + Nivolumab for Lung Cancer

No longer recruiting at 55 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bristol-Myers Squibb

Disqualifiers: CNS metastases, Concurrent malignancy, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new drug, BMS-986442, combined with nivolumab (an immunotherapy drug), with or without chemotherapy, for treating lung cancer. The study includes different groups exploring various combinations to determine the most effective approach. It seeks participants with non-small cell lung cancer (a common type) who have undergone some prior treatments. Participants should have a measurable condition and be in relatively good health with a life expectancy of at least three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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?

Previous studies have tested the combination of BMS-986442 and nivolumab for safety in people with solid tumors, including non-small cell lung cancer. Research has shown that this combination is generally manageable, with safety closely monitored during testing. When combined with other treatments, nivolumab has demonstrated a manageable safety profile in patients with advanced lung cancer. Some known side effects exist, but they are often treatable.

Studies are also examining the safety of combining BMS-986442, nivolumab, and chemotherapy drugs like docetaxel, carboplatin, pemetrexed, and paclitaxel. As this is a newer combination, more information is still being gathered. However, each of these drugs has been used in cancer treatment before, providing doctors with some understanding of their safety.

Since these treatments are in the early stages of clinical trials, safety remains a primary focus. Doctors closely monitor any side effects and make adjustments as needed. Participants should discuss any concerns with their healthcare provider to fully understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine BMS-986442 with Nivolumab, aiming to enhance the body's immune response against lung cancer. Unlike standard chemotherapy treatments, which directly attack cancer cells, this combination leverages the body's own immune system to target and destroy cancer cells more effectively. BMS-986442 is a novel agent designed to work synergistically with Nivolumab, an established immunotherapy drug, potentially leading to improved outcomes for patients. Additionally, some treatment arms explore the combination with other chemotherapy agents like Docetaxel, Carboplatin, Pemetrexed, and Paclitaxel, which could offer more comprehensive treatment strategies. This innovative approach could provide new hope for patients with lung cancer, especially those who have not responded well to standard treatments.

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

Research shows that combining BMS-986442 with nivolumab may help treat lung cancer. Studies have found that nivolumab alone greatly improves survival rates and slows disease progression in patients with advanced lung cancer. In this trial, some participants will receive BMS-986442 combined with nivolumab, while others will receive this combination alongside chemotherapy drugs like docetaxel, carboplatin, or paclitaxel. These combinations aim to enhance treatment benefits. Although early results are promising, researchers continue to study these combinations to understand their effectiveness. ^{1 2 3 4 6}

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 certain types of lung or solid tumors who are in fairly good physical condition (able to carry out daily activities with ease or minor limitations) and expected to live at least 3 more months. They must have measurable tumor growth that can be tracked over time. People with untreated brain metastases, another cancer needing treatment, or active autoimmune diseases cannot join.

Inclusion Criteria

You must have a measurable disease according to specific guidelines.

Participants must have a life expectancy of at least 3 months at the time of first dose.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I don't have another cancer needing treatment or one active in the last 2 years.

I have brain or spinal cord metastases that haven't been treated.

You have a current, known, or suspected autoimmune disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986442 in combination with nivolumab, with or without chemotherapy, for antitumor efficacy

6 months

Visits aligned with treatment cycles

Dose Limiting Toxicity Evaluation

Evaluation of dose limiting toxicities within the first 28 days of treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986442
• Carboplatin
• Docetaxel
• Nivolumab
• Paclitaxel
• Pemexetred

Trial Overview The study tests BMS-986442 combined with Nivolumab, a type of immunotherapy, and may include chemotherapy drugs like Pemexetred, Paclitaxel, Docetaxel, or Carboplatin. The goal is to see if this combination helps shrink the tumors better than current treatments.

How Is the Trial Designed?

Group I: Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel Experimental Treatment 4 Interventions

Group II: Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed Experimental Treatment 4 Interventions

Group III: Part C: BMS-986442 + Nivolumab + Docetaxel Experimental Treatment 3 Interventions

Group IV: Part B2: BMS-986442 + Nivolumab Experimental Treatment 2 Interventions

Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)

Group V: Part B1: BMS-986442 + Nivolumab Experimental Treatment 2 Interventions

Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)

Group VI: Part A: BMS-986442 + Nivolumab Experimental Treatment 2 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

Published Research Related to This Trial

Nivolumab is the first approved PD-1 inhibitor that helps the immune system fight against tumors, specifically for patients with unresectable melanoma.

Early phase studies have shown promising results for nivolumab in treating solid tumors like non-small cell lung cancer (NSCLC), especially when combined with chemotherapy and other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab in NSCLC: latest evidence and clinical potential. Sundar, R., Cho, BC., Brahmer, JR., et al.[2022]

Nivolumab, an immune checkpoint inhibitor, significantly improved overall survival and progression-free survival compared to docetaxel in patients with advanced squamous non-small cell lung cancer (NSCLC) in the CheckMate 017 trial.

Nivolumab was better tolerated than docetaxel, with manageable adverse effects, making it a promising treatment option for patients who have already undergone chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: a review in advanced squamous non-small cell lung cancer. Keating, GM.[2022]

In the Asian subpopulation with advanced non-small cell lung cancer (NSCLC) and PD-L1 expression ≥1%, patients treated with nivolumab plus ipilimumab showed significantly improved overall survival (OS) and progression-free survival (PFS) compared to those receiving chemotherapy, with a 3-year OS rate of 53% versus 37%.

The safety profile of nivolumab plus ipilimumab was manageable, with grade 3-4 treatment-related adverse events occurring in 40% of patients, similar to the 36% in the chemotherapy group, indicating no new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients. O'Byrne, KJ., Lee, KH., Kim, SW., et al.[2022]

Nivolumab, an immune checkpoint inhibitor, significantly improves overall survival and progression-free survival in patients with advanced stage squamous cell non-small cell lung cancer (NSCLC) compared to docetaxel, as shown in the CHECKMATE 017 study.

The safety and tolerability of nivolumab are favorable, and interestingly, the expression of the PD-L1 ligand does not predict treatment outcomes, suggesting that other factors may influence the effectiveness of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence. Lim, JS., Soo, RA.[2018]

In a phase 2 trial involving 117 patients with advanced, refractory squamous non-small-cell lung cancer, nivolumab demonstrated a 14.5% objective response rate, indicating its potential effectiveness as a treatment option.

The safety profile of nivolumab was manageable, with 17% of patients experiencing severe treatment-related adverse events, suggesting that while there are risks, the benefits may outweigh them for patients with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Rizvi, NA., Mazières, J., Planchard, D., et al.[2022]

Nivolumab (Opdivo) significantly improves overall survival and response rates in previously-treated patients with advanced nonsquamous non-small cell lung cancer (NSCLC) compared to docetaxel, as shown in the CheckMate 057 trial.

Nivolumab has a manageable adverse event profile and is better tolerated than docetaxel, making it a valuable treatment option for patients who have progressed after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. Keating, GM.[2018]

In a phase I study involving 56 patients with advanced non-small-cell lung cancer, nivolumab combined with platinum-based chemotherapy showed promising efficacy, particularly with a 2-year overall survival rate of 62% for the nivolumab 5 mg/kg plus paclitaxel-carboplatin group.

While the safety profile was generally consistent with expectations, 45% of patients experienced grade 3 or 4 treatment-related adverse events, and 21% discontinued treatment due to these adverse effects, indicating a need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. Rizvi, NA., Hellmann, MD., Brahmer, JR., et al.[2022]

Nivolumab plus ipilimumab showed durable and long-term efficacy in treating advanced non-small cell lung cancer (NSCLC) compared to chemotherapy, regardless of tumor PD-L1 expression levels.

These findings are based on updated results from part 1 of the phase 3 CheckMate 227 trial, indicating that this combination therapy could be a more effective frontline treatment option for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab/Ipilimumab Combo Yields Durable Efficacy in Advanced NSCLC. Kahl, KL.[2021]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/29/NCT05543629/Prot_SAP_000.pdf

A Phase 1b/2 Study of BMS-986442 in Combination With ... nivolumab in previously treated advanced non-small cell lung cancer (NSCLC): clinical characteristics of long-term survivors. Cancer Res ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-of-bms-986442-and-nivolumab-alone-or-with-chemotherapy-for-patients-with-advanced-solid-tumors-and-non-small-cell-lung-cancer/

Study of BMS-986442 and Nivolumab, Alone or with ... This study explores the efficacy of BMS-986442 and Nivolumab, used individually or in conjunction with chemotherapy, for treating patients ...

3. bms.com bms.com/assets/bms/shared/plain-language-summary/ca115-001/ca115-001-pls-en-final-approved.pdf

Plain Language Summary of Clinical Study Results With your help, we learned more about BMS-986442, its safety, and its effect on solid tumors or lung cancer when used together with nivolumab.

4. trial.medpath.com trial.medpath.com/clinical-trial/7f53f44e6a86c7f8/nct05543629-bms-986442-nivolumab-solid-tumors

A Study of BMS-986442 With Nivolumab With or Without ... The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and b...

5. bmsstudyconnect.com bmsstudyconnect.com/it/en/clinical-trials/NCT05543629.html

A Study of BMS-986442 With Nivolumab With or Without ... The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy ...

6. withpower.com withpower.com/trial/phase-2-non-small-cell-lung-cancer-8-2022-68c8b

BMS-986442 + Nivolumab for Lung Cancer Nivolumab, used in combination with other treatments, has been shown to have a manageable safety profile in patients with advanced non-small cell lung ...