905 Participants Needed

BMS-986340 + Nivolumab/Docetaxel for Cancer

Recruiting at 99 trial locations
Fl
Rs
BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, BMS-986340, alone and with other cancer treatments (nivolumab and docetaxel) in patients with advanced solid tumors. The goal is to find out if it is safe and effective in treating these cancers.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on corticosteroids or other immunosuppressive medications, you may need to stop them 14 to 30 days before starting the study treatment.

Is the combination of BMS-986340 and Nivolumab/Docetaxel safe for humans?

Nivolumab, when compared to docetaxel, has shown a favorable safety profile in patients with advanced non-small cell lung cancer, indicating it is generally safe for human use in this context.12345

What makes the drug BMS-986340 + Nivolumab/Docetaxel unique for cancer treatment?

This drug combination is unique because it includes BMS-986340, an anti-CCR8 antibody, which is a novel approach to targeting cancer cells, combined with Nivolumab, a PD-1 inhibitor that has shown improved survival rates over traditional chemotherapy like Docetaxel in non-small-cell lung cancer (NSCLC). This combination leverages the immune system to fight cancer more effectively than standard treatments.35678

What data supports the effectiveness of the drug BMS-986340 + Nivolumab/Docetaxel for cancer?

Research shows that Nivolumab, one of the drugs in the treatment, has been effective in improving survival in patients with advanced non-small-cell lung cancer (NSCLC) compared to Docetaxel, another component of the treatment.23689

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 solid tumors who've tried, can't tolerate, or have no other treatment options. They must have measurable disease and provide tumor biopsies for analysis. Not eligible if they had recent major surgery, are pregnant/breastfeeding, have certain lung diseases or autoimmune conditions, untreated brain metastases, or need steroids/immunosuppressants.

Inclusion Criteria

I can provide fresh biopsy samples before and during treatment for testing.
I have received all standard treatments for my cancer, except docetaxel in advanced stages.
I am fully active or can carry out light work.
See 3 more

Exclusion Criteria

I have received an organ or tissue transplant from another person.
I have an autoimmune disease.
I have or had lung scarring or interstitial lung disease.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986340 as monotherapy or in combination with nivolumab or docetaxel to assess safety, tolerability, and recommended dose(s)

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-936558-01
  • BMS-986340
  • Docetaxel
Trial Overview The study tests BMS-986340 alone and combined with Nivolumab (BMS-936558-01) or Docetaxel in patients with various advanced cancers to find safe doses and see how well they work. It's the first time BMS-986340 is being given to humans in this setting.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Part 2B: BMS-986340 + Nivolumab Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 2A: BMS-986340 Dose ExpansionExperimental Treatment1 Intervention
Group III: Part 1C: BMS-986340 + Docetaxel Dose EscalationExperimental Treatment2 Interventions
Group IV: Part 1B: BMS-986340 + Nivolumab Dose EscalationExperimental Treatment2 Interventions
Group V: Part 1A: BMS-986340 Dose EscalationExperimental 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

Published Research Related to This Trial

In a real-world study of 371 patients with advanced squamous non-small cell lung cancer (NSCLC) receiving nivolumab, the objective response rate was 18% and the median overall survival was 7.9 months, indicating that nivolumab is effective in this patient population.
The safety profile of nivolumab was favorable, with only 29% of patients experiencing any-grade adverse events and no treatment-related deaths, suggesting that its use in routine clinical practice aligns with findings from controlled clinical trials.
Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer: Results from a Real-World Population.Crinò, L., Bidoli, P., Delmonte, A., et al.[2020]
In a phase 3 trial involving 423 patients with untreated stage IV or recurrent non-small-cell lung cancer (NSCLC) and PD-L1 expression of 5% or more, nivolumab did not show a significant improvement in progression-free survival compared to chemotherapy, with median times of 4.2 months versus 5.9 months, respectively.
Nivolumab demonstrated a better safety profile than chemotherapy, with 71% of patients experiencing treatment-related adverse events compared to 92% in the chemotherapy group, and significantly fewer severe adverse events (grade 3 or 4) at 18% versus 51%.
First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer.Carbone, DP., Reck, M., Paz-Ares, L., et al.[2022]
Nivolumab, an immune checkpoint inhibitor, showed a tolerable safety profile in 52 patients with advanced non-small-cell lung cancer (NSCLC), with 71% experiencing treatment-related adverse events, primarily fatigue and rash.
The treatment resulted in a confirmed objective response rate of 23%, with some patients achieving ongoing complete responses, and a median overall survival of 19.4 months, indicating its potential as an effective first-line therapy for advanced NSCLC.
Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.Gettinger, S., Rizvi, NA., Chow, LQ., et al.[2022]

Citations

Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer: Results from a Real-World Population. [2020]
First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. [2022]
Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. [2022]
Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC. [2020]
Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. [2022]
Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. [2019]
Impact of Nivolumab versus Docetaxel on Health-Related Quality of Life and Symptoms in Patients with Advanced Squamous Non-Small Cell Lung Cancer: Results from the CheckMate 017 Study. [2019]
Three-year follow-up results from phase II studies of nivolumab in Japanese patients with previously treated advanced non-small cell lung cancer: Pooled analysis of ONO-4538-05 and ONO-4538-06 studies. [2021]
Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). [2022]
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