BMS-986340 + Nivolumab/Docetaxel for Cancer

Recruiting at 105 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

949 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a new cancer treatment, BMS-986340, used alone or with other drugs like nivolumab (an immunotherapy drug) or docetaxel (a chemotherapy drug). It targets individuals with advanced solid tumors who have not responded to standard treatments. Participants must have tumors suitable for biopsy and be experiencing disease progression. The study aims to determine the appropriate dosage and monitor for side effects. It offers patients with limited options the opportunity to explore new treatment possibilities. As a Phase 1 trial, this research seeks to understand how the treatment works in people, allowing participants to be among the first to receive this new treatment.

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

Research has shown that BMS-986340, an anti-CCR8 monoclonal antibody, is under study to determine its safety in humans. Detailed safety information is not yet available. This treatment targets a part of the immune system involved in cancer. As this is its first human trial, the primary goal is to identify a safe dose and monitor for side effects.

When combined with nivolumab, a drug that aids the immune system in fighting cancer, researchers are also assessing its safety. Nivolumab is already approved for other cancer types and is generally considered safe. However, its use with BMS-986340 is new, and the safety of this combination is still under investigation.

BMS-986340 is also being tested with docetaxel, a chemotherapy drug. The focus remains on safety and patient tolerance. Docetaxel is commonly used and has known side effects, but its interaction with BMS-986340 is being studied.

In summary, these treatments are still under investigation for safety. This trial aims to understand how well patients tolerate these new combinations and to identify any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because BMS-986340 is believed to offer a fresh approach to cancer treatment. Unlike traditional treatments like chemotherapy, this experimental drug is designed to potentially enhance the body's immune response against cancer cells. When combined with Nivolumab, an immune checkpoint inhibitor, it might further amplify this effect, providing a powerful one-two punch against tumors. Additionally, the combination with Docetaxel, a well-known chemotherapy agent, could offer a new way to increase the effectiveness of cancer cell targeting. These strategies represent a novel way to tackle cancer, offering hope for improved outcomes.

What evidence suggests that this trial's treatments could be effective for advanced solid tumors?

Research has shown that BMS-986340, a new type of medicine, can lower the number of certain cells in tumors that help cancer evade the immune system. By reducing these cells, tumors might become easier to treat. In this trial, some participants will receive BMS-986340 with nivolumab, a drug that has extended the lives of some cancer patients, potentially strengthening the body's defense against tumors. Other participants will receive BMS-986340 with docetaxel, which stops cancer cells from growing and has effectively treated various types of cancer. The combination of BMS-986340 with these treatments aims to enhance the body's ability to fight advanced solid tumors. Although human studies provide limited information, early results suggest this could be a promising approach to tackling difficult cancers. ^{1 2 6 7 8}

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 1B-J: BMS-986340 + Nivolumab Dose Escalation Experimental Treatment 2 Interventions

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

Group VII: Part 1A-J: 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 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 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]

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 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]

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]

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]

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]

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]

Citations

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Anti-CCR8 Antibodies Market to Witness Remarkable ... Some of the key anti-CCR8 antibodies in the pipeline include BMS-986340 (ONO-7427) + OPDIVO, CHS-114 ± LOQTORZI, GS-1811 ± Zimberelimab, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10669377/

CCR8 as a Therapeutic Novel Target: Omics-Integrated ... This research advances our understanding of CCR8 as a potential target for anti-cancer drug development, bridging the gap between molecular insights and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04895709

NCT04895709 | A Study of BMS-986340 as Monotherapy ... The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or ...

4. aacrjournals.org aacrjournals.org/cancerres/article/80/16_Supplement/6694/644659/Abstract-6694-Highly-selective-anti-CCR8-antibody

Abstract 6694: Highly selective anti-CCR8 antibody-mediated ... Conclusions: BMS-986340, a novel anti-CCR8 NF monoclonal antibody in development, led to measurable CCR8+ Treg depletion in human tumor explants ...

5. bms.com bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2025/BMY-2025-Q3-Results-Investor-Presentation-with-Appendix.pdf

Q3 2025 Results Presentation (with Appendix) This presentation contains statements about Bristol-Myers Squibb Company's (the. “Company”) future financial results, plans, ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04895709/

Clinical Trial: NCT04895709 The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in ...

7. bms.com bms.com/assets/bms/us/en-us/pdf/CCR8-Immune-Pathway-Fact-Sheet.pdf

CC Chemokine Receptor 8 (CCR8) Immune Pathway Receptors like CCR8 and their chemokines play an important role in the immune system's response to cancer. Chemokine and chemokine receptor expression influence ...

8. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/imzokitug

Definition of anti-CCR8 monoclonal antibody BMS-986340 CCR8 is specifically expressed by tumor-infiltrating Tregs in multiple types of cancer and plays a key role in immunosuppression. High expression is correlated ...