36 Participants Needed

BMS-986442 + Nivolumab for Lung Cancer

Recruiting at 51 trial locations
Fl
BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BMS-986442 together with nivolumab, and sometimes chemotherapy, to see if it can help fight cancer more effectively.

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.

What data supports the effectiveness of the drug Nivolumab for lung cancer?

Nivolumab has been shown to significantly improve overall survival and progression-free survival in patients with advanced squamous non-small cell lung cancer (NSCLC) compared to docetaxel, as demonstrated in the CheckMate 017 trial. It is also better tolerated, making it an important option for previously-treated advanced NSCLC.12345

Is the combination of BMS-986442 and Nivolumab safe for humans?

Nivolumab, used in combination with other treatments, has been shown to have a manageable safety profile in patients with advanced non-small cell lung cancer (NSCLC). It was better tolerated than some other treatments like docetaxel, with manageable side effects, including immune-related ones.12456

What makes the drug combination of BMS-986442 and Nivolumab unique for lung cancer treatment?

The combination of BMS-986442 and Nivolumab is unique because Nivolumab is a PD-1 immune checkpoint inhibitor that has shown improved survival rates in advanced lung cancer, and combining it with BMS-986442 may enhance its effectiveness by potentially targeting different pathways in the immune system.12378

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

Interventions

  • BMS-986442
  • Carboplatin
  • Docetaxel
  • Nivolumab
  • Paclitaxel
  • Pemexetred
Trial OverviewThe 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.
Participant Groups
6Treatment groups
Experimental Treatment
Group I: Part E: BMS-986442 + Nivolumab + Carboplatin + PaclitaxelExperimental Treatment4 Interventions
Group II: Part D: BMS-986442 + Nivolumab + Carboplatin + PemetrexedExperimental Treatment4 Interventions
Group III: Part C: BMS-986442 + Nivolumab + DocetaxelExperimental Treatment3 Interventions
Group IV: Part B2: BMS-986442 + NivolumabExperimental Treatment2 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 + NivolumabExperimental Treatment2 Interventions
Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)
Group VI: Part A: BMS-986442 + NivolumabExperimental Treatment2 Interventions

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

Findings from Research

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

References

Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence. [2018]
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. [2022]
Nivolumab/Ipilimumab Combo Yields Durable Efficacy in Advanced NSCLC. [2021]
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]
First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients. [2022]
Nivolumab in NSCLC: latest evidence and clinical potential. [2022]
Nivolumab in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. [2022]