BMS-986360 + Chemotherapy/Nivolumab for Advanced Cancer

Recruiting at 83 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: CNS disease, Concurrent malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called BMS-986360, both alone and in combination with other therapies, for individuals with advanced solid tumors. Researchers aim to determine the safety and tolerability of this treatment, particularly when combined with chemotherapy or the drug nivolumab. It targets those diagnosed with specific cancers, such as non-small cell lung cancer or metastatic triple-negative breast cancer, who have not responded to standard treatments. For those with advanced cancer that has spread or cannot be surgically removed, this trial may be suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering a chance to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you need systemic corticosteroids or other immunosuppressive medications within 14 to 30 days before starting the trial.

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

Research shows that BMS-986360 is being tested for safety both alone and in combination with treatments like chemotherapy and nivolumab. As these studies are in the early stages, clear information about its safety is not yet available. The primary focus is on assessing its safety and potential side effects in people.

Nivolumab, one of the drugs used with BMS-986360, has been studied in cancers such as lung cancer and melanoma. These studies indicate that nivolumab is generally safe, with manageable side effects. Capecitabine, another drug combined with BMS-986360, is commonly used in breast cancer treatment and is known to be effective, though it also has its own side effects.

While the safety of BMS-986360 is still under investigation, combining it with these established drugs reflects a careful approach to safety. Researchers will closely monitor participants for any adverse reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BMS-986360 because it offers a unique approach to treating advanced cancer. Unlike most standard treatments, which typically include chemotherapy or immune checkpoint inhibitors like nivolumab, BMS-986360 introduces a novel mechanism of action. This investigational drug is believed to enhance the body's immune response against cancer cells while potentially overcoming resistance to current therapies. Additionally, the combination arms exploring BMS-986360 with existing treatments like docetaxel, nivolumab, and capecitabine may offer synergetic effects, improving outcomes for patients with advanced cancers. This fresh strategy could lead to more effective and personalized treatment options for those who have limited responses to existing therapies.

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

Research shows that BMS-986360 is a new treatment being tested for its potential to fight advanced cancers. In this trial, participants will receive BMS-986360 in various combinations: with chemotherapy drugs like Docetaxel or Capecitabine, or with Nivolumab, to assess whether these combinations can improve patient outcomes. Nivolumab is already known to help treat some lung cancers, especially when combined with chemotherapy, by increasing survival rates. Docetaxel has helped cancer patients live longer, and Capecitabine has been effective for advanced colorectal and breast cancers, improving patient response to treatment. While researchers continue to study BMS-986360, these combinations are based on treatments that have already shown benefits in cancer therapy. ^{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 advanced solid tumors, including lung cancer and breast cancer, who have tried standard treatments without success. They must be in good physical condition (ECOG 0 or 1) and have a tumor that can be biopsied. People with primary brain tumors or only brain metastases, recent steroid use, other active cancers within the last two years, or specific genetic mutations treatable by targeted therapy are excluded.

Inclusion Criteria

My condition hasn't improved with standard treatments, including immunotherapy for NSCLC.

My advanced lung or triple-negative breast cancer is measurable by specific criteria.

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had any cancer except for early skin cancer or non-invasive cancer in the last 2 years.

I haven't taken high-dose steroids or immunosuppressants recently.

I do not have cancer that started in or has only spread to my brain, or if I do, it's under control without new symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986360 alone or in combination with chemotherapy or nivolumab

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986360
• Capecitabine
• Docetaxel
• Nivolumab

Trial Overview The study tests BMS-986360 alone and combined with chemotherapy drugs like Docetaxel and Capecitabine or the immunotherapy drug Nivolumab in patients with advanced solid tumors. It aims to find out how safe these treatments are and how well they're tolerated when given together.

How Is the Trial Designed?

Group I: BMS-986360 + Nivolumab Experimental Treatment 2 Interventions

Group II: BMS-986360 + Docetaxel Experimental Treatment 2 Interventions

Group III: BMS-986360 + Capecitabine Experimental Treatment 2 Interventions

Group IV: BMS-986360 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

Nivolumab combined with a multi-peptide vaccine was well tolerated in 33 patients with resected stage IIIC and IV melanoma, with no maximum tolerated dose reached and manageable side effects like fatigue and rash.

The treatment showed promising results with a median relapse-free survival of 47.1 months, indicating potential effectiveness in preventing cancer recurrence in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, correlative markers, and clinical results of adjuvant nivolumab in combination with vaccine in resected high-risk metastatic melanoma. Gibney, GT., Kudchadkar, RR., DeConti, RC., et al.[2022]

In the phase III CheckMate 9LA trial with 30.7 months of follow-up, the combination of nivolumab and ipilimumab with chemotherapy significantly improved overall survival (OS) in patients with advanced non-small-cell lung cancer, with a median OS of 15.8 months compared to 11.0 months for chemotherapy alone.

The combination treatment also showed a manageable safety profile, with no new safety signals and most severe treatment-related adverse events occurring during the first two cycles, indicating it is a viable first-line option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update. Reck, M., Ciuleanu, TE., Cobo, M., et al.[2021]

The phase I/IIa study of BMS-986178, an OX40 agonist, showed a manageable safety profile with low rates of severe treatment-related adverse events (5% for monotherapy and up to 15% for combination therapy), indicating it is safe for use in patients with advanced solid tumors.

Despite the safety, the study did not find significant efficacy for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, with no objective responses observed in monotherapy and low response rates (0% to 13%) in combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OX40 Agonist BMS-986178 Alone or in Combination With Nivolumab and/or Ipilimumab in Patients With Advanced Solid Tumors. Gutierrez, M., Moreno, V., Heinhuis, KM., et al.[2022]

BMS-986148, a mesothelin-directed antibody-drug conjugate, showed a manageable safety profile in a phase I/IIa study with 126 patients, with common treatment-related adverse events including increased liver enzymes.

Preliminary evidence of clinical activity was observed with BMS-986148 alone and in combination with nivolumab, suggesting potential for further studies on combining targeted therapies with immune checkpoint inhibitors in advanced solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa Trial of BMS-986148, an Anti-mesothelin Antibody-drug Conjugate, Alone or in Combination with Nivolumab in Patients with Advanced Solid Tumors. Rottey, S., Clarke, J., Aung, K., et al.[2023]

In a study of 109 patients with malignant pleural mesothelioma (MPM) treated with second-line nivolumab, the objective response rate was 15.6%, and the disease-control rate was 46.8%, indicating that nivolumab can be effective in real-life settings.

Factors such as having a biphasic tumor subtype and low albumin levels were identified as significant predictors of overall survival, suggesting that these characteristics could help guide treatment decisions for MPM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Checkpoint Inhibitors for Malignant Pleural Mesothelioma: A French, Multicenter, Retrospective Real-World Study. Assié, JB., Crépin, F., Grolleau, E., et al.[2023]

In a retrospective study of patients with pulmonary adenocarcinomas treated with nivolumab, no significant differences were found in objective response rates or progression-free survival based on previous chemotherapy regimens.

However, there was a trend indicating that patients previously treated with carboplatin plus taxanes or vinorelbine (with or without bevacizumab) had better overall survival compared to those treated with cisplatin and pemetrexed, suggesting that the former may be a more effective combination for immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Previous Chemotherapy Affect the Outcome of Nivolumab Treatment in Non-small Cell Lung Cancer? Svaton, M., Bratova, M., Koubkova, L., et al.[2022]

In a study of 34 Japanese patients with previously treated malignant pleural mesothelioma, nivolumab demonstrated a 3-year overall survival rate of 23.5% and a median overall survival of 17.3 months, indicating its long-term efficacy.

Nivolumab was well tolerated with no new safety concerns, and patient-reported outcomes remained stable throughout the treatment, suggesting it is a safe option for patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Safety of Nivolumab in Japanese Patients With Malignant Pleural Mesothelioma: 3-Year Results of the MERIT Study. Fujimoto, N., Okada, M., Kijima, T., et al.[2022]

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]

In a study of 52 patients with advanced non-small-cell lung cancer (NSCLC) treated with nivolumab, the drug demonstrated a 23.1% overall response rate and a 1-year overall survival rate of 59.9%, indicating its efficacy in a real-world setting.

Nivolumab had a manageable safety profile, with immune-related adverse events occurring in 38.5% of patients, all of whom recovered after treatment; additionally, a high pretreatment neutrophil-to-lymphocyte ratio (NLR ≥ 5) was linked to poorer prognosis, suggesting it could serve as a predictive marker for survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of Nivolumab and Utility of Neutrophil-to-Lymphocyte Ratio as a Predictive Biomarker for Advanced Non-Small-Cell Lung Cancer: A Prospective Observational Study. Fukui, T., Okuma, Y., Nakahara, Y., et al.[2022]

In a phase II trial involving patients with stage IIIA resectable non-small-cell lung cancer (NSCLC), the combination of neoadjuvant chemotherapy and nivolumab resulted in a 3-year overall survival rate of 81.9%, indicating its efficacy as a treatment option.

Circulating tumor DNA (ctDNA) levels were found to be significant predictors of overall survival, outperforming traditional radiologic assessments, with undetectable ctDNA after treatment strongly associated with improved survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overall Survival and Biomarker Analysis of Neoadjuvant Nivolumab Plus Chemotherapy in Operable Stage IIIA Non-Small-Cell Lung Cancer (NADIM phase II trial). Provencio, M., Serna-Blasco, R., Nadal, E., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05625412

NCT05625412 | A Study of BMS-986360/CC-90001 Alone ... The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in ...

2. withpower.com withpower.com/trial/phase-1-neoplasms-10-2022-8b002

BMS-986360 + Chemotherapy/Nivolumab for Advanced ... Research shows that nivolumab, when combined with chemotherapy, has been effective in treating certain types of lung cancer, improving survival rates compared ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00866

A Study of BMS-986360/CC-90001 Alone and in ... The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in ...

4. bmsstudyconnect.com bmsstudyconnect.com/no/en/clinical-trials/NCT05625412.html

A Study of BMS-986360/CC-90001 Alone and in Combination ... The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=13db808d-3ff6-427a-a76a-7be01e06fba0

BMS-986360 / BMS A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=70 | Completed ...

6. clinconnect.io clinconnect.io/trials/NCT05625412

A Study of BMS-986360/CC-90001 Alone and in Combination The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in ...