BMS-986340 + Nivolumab/Docetaxel for Cancer

Recruiting at 99 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

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Pregnancy, CNS malignancy, Autoimmune, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 weeks

905 Participants Needed

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. ^{1 2 3 4 5}

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. ^{3 5 6 7 8}

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. ^{2 3 6 8 9}

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 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.

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.

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?

Group I: Part 2B: BMS-986340 + Nivolumab Dose Expansion Experimental Treatment 2 Interventions

Group II: Part 2A: BMS-986340 Dose Expansion Experimental Treatment 1 Intervention

Group III: Part 1C: BMS-986340 + Docetaxel Dose Escalation Experimental Treatment 2 Interventions

Group IV: Part 1B: BMS-986340 + Nivolumab Dose Escalation Experimental Treatment 2 Interventions

Group V: Part 1A: BMS-986340 Dose Escalation Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. Gettinger, S., Rizvi, NA., Chow, LQ., et al.[2022]

In the KEYNOTE-010 study involving patients with advanced NSCLC, pembrolizumab significantly improved health-related quality of life (HRQoL) scores compared to docetaxel, indicating better overall patient well-being during treatment.

Patients treated with pembrolizumab experienced less deterioration in symptoms like cough and dyspnea, and showed a significant prolongation in time to deterioration for these symptoms, particularly at the 10 mg/kg dose compared to docetaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Barlesi, F., Garon, EB., Kim, DW., et al.[2020]

In a phase 3 study involving 272 patients with advanced squamous-cell non-small-cell lung cancer, nivolumab significantly improved overall survival (9.2 months) compared to docetaxel (6.0 months), with a 41% lower risk of death.

Nivolumab also had a better safety profile, with only 7% of patients experiencing severe treatment-related adverse events, compared to 55% in the docetaxel group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. Brahmer, J., Reckamp, KL., Baas, P., et al.[2022]

In a phase III trial, nivolumab significantly improved health-related quality of life (HRQoL) and disease-related symptoms compared to docetaxel in patients with advanced non-squamous non-small cell lung cancer, with improvements noted at multiple time points (weeks 12, 24, 30, and 42).

Patients receiving nivolumab experienced a longer time to first deterioration in HRQoL compared to those treated with docetaxel, indicating a more favorable safety profile and sustained symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Reck, M., Brahmer, J., Bennett, B., et al.[2019]

In the phase III CheckMate 017 study, nivolumab significantly improved health-related quality of life (HRQoL) and reduced symptom burden in patients with advanced squamous non-small cell lung cancer (NSCLC) compared to docetaxel, with clinically meaningful improvements observed from weeks 42 to 84.

While both nivolumab and docetaxel showed similar initial improvements in symptom scores at week 12, only nivolumab demonstrated sustained benefits over time, with a longer time to first HRQoL deterioration, indicating its potential as a more effective second-line treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Reck, M., Taylor, F., Penrod, JR., et al.[2019]

Nivolumab significantly improves long-term overall survival in patients with advanced squamous and non-squamous non-small cell lung cancer (NSCLC), with median survival times of 16.3 months for squamous and 17.1 months for non-squamous patients, and 3-year survival rates of 20.0% and 31.9%, respectively.

The treatment was well tolerated, with no new safety concerns identified, indicating that nivolumab is a safe and effective option for patients who have previously been treated for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Horinouchi, H., Nishio, M., Hida, T., et al.[2021]

Nivolumab significantly improved overall survival rates compared to docetaxel in patients with advanced non-small-cell lung cancer (NSCLC), with two-year survival rates of 23% for squamous and 29% for nonsquamous NSCLC versus 8% and 16% respectively.

Nivolumab also demonstrated a better safety profile, with lower rates of treatment-related adverse events (68% vs 88% for any grade and 10% vs 55% for grade 3 to 4) compared to docetaxel, indicating it is a more tolerable option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Horn, L., Spigel, DR., Vokes, EE., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Italian Cohort of Nivolumab Expanded Access Program in Squamous Non-Small Cell Lung Cancer: Results from a Real-World Population. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

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]