281 Participants Needed

BMS-986253 + Immunotherapy for Advanced Cancer

Recruiting at 169 trial locations
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Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called BMS-986253 along with other cancer treatments, Nivolumab and Ipilimumab, in patients with advanced cancers to see if it can improve their effectiveness.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot take certain immunosuppressive medications or corticosteroids above a certain dose within 14 days of starting the study. Also, if you are on cytotoxic agents, you need to wait at least 4 weeks after your last dose before starting the trial.

What data supports the effectiveness of the drug BMS-986253 + Immunotherapy for Advanced Cancer?

Research shows that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) has been effective in treating advanced non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma, with better survival rates compared to chemotherapy. This suggests that similar combinations, like BMS-986253 with immunotherapy, might also be effective for advanced cancers.12345

What is the safety profile of BMS-986253 and related immunotherapies?

Immunotherapies like ipilimumab and nivolumab can cause immune-related side effects, which may include diarrhea, liver inflammation, lung issues, kidney problems, and heart issues. While most side effects are mild and manageable, some can be serious and require hospital visits or stopping the treatment. It's important for patients to be monitored closely and treated promptly if side effects occur.678910

What makes the drug BMS-986253 + Immunotherapy unique for advanced cancer?

This treatment combines BMS-986253, an anti-IL-8 drug, with the immunotherapy drugs nivolumab and ipilimumab, which are known to enhance the body's immune response against cancer. This combination is unique because it targets multiple pathways to potentially improve treatment effectiveness compared to using these drugs individually.2341112

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced solid tumors, who are physically capable of daily activity or light work. They must have a tumor that can be measured and one that's reachable for biopsy. People taking high-dose steroids, recent cytotoxic agents, those with HIV/AIDS, or active autoimmune diseases cannot join.

Inclusion Criteria

I am fully active or can carry out light work.
My cancer has spread, cannot be surgically removed, and can be measured by scans.
I have a tumor that can be biopsied.

Exclusion Criteria

I have brain metastases but they are under control.
You have an ongoing autoimmune disease.
It's been over 4 weeks since my last cancer treatment.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab

Approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BMS-986253
  • Ipilimumab
  • Nivolumab
Trial OverviewThe study tests BMS-986253 in combination with Nivolumab or both Nivolumab and Ipilimumab against cancer. Participants will receive either the experimental medication plus standard treatments or a placebo alongside standard treatments to compare effectiveness.
Participant Groups
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2A: BMS-986253 + nivolumab + ipilimumabExperimental Treatment3 Interventions
Group II: Part 1C: BMS-986253 + nivolumab + ipilimumabExperimental Treatment3 Interventions
Group III: Part 1B: BMS-986253 + nivolumabExperimental Treatment2 Interventions
Group IV: Part 1A: BMS-986253 + nivolumabExperimental Treatment2 Interventions
Group V: Part 2B: Placebo + nivolumab + ipilimumabPlacebo Group3 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 plus ipilimumab showed durable and long-term efficacy in treating advanced non-small cell lung cancer (NSCLC) compared to chemotherapy, regardless of tumor PD-L1 expression levels.
These findings are based on updated results from part 1 of the phase 3 CheckMate 227 trial, indicating that this combination therapy could be a more effective frontline treatment option for NSCLC patients.
Nivolumab/Ipilimumab Combo Yields Durable Efficacy in Advanced NSCLC.Kahl, KL.[2021]
Nivolumab (Opdivo) combined with ipilimumab (Yervoy) has been approved by the FDA as a first-line treatment for adults with unresectable malignant pleural mesothelioma, based on promising results from the CHECKMATE 743 trial.
The approval was supported by an interim analysis comparing the combination therapy to standard chemotherapy, indicating that this new treatment option may offer better outcomes for patients with this challenging cancer.
FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma.Wright, K.[2021]
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]

References

Nivolumab/Ipilimumab Combo Yields Durable Efficacy in Advanced NSCLC. [2021]
FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma. [2021]
Nivolumab: a review in advanced squamous non-small cell lung cancer. [2022]
Nivolumab: A Review in Advanced Nonsquamous Non-Small Cell Lung Cancer. [2018]
First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 4-Year Outcomes From the Randomized, Open-Label, Phase 3 CheckMate 227 Part 1 Trial. [2022]
Real-World Adherence to Toxicity Management Guidelines for Immune-Related Adverse Events. [2022]
Ipilimumab for advanced melanoma: a pharmacologic perspective. [2021]
Ipilimumab for advanced melanoma: a nursing perspective. [2017]
Safety profile of immune checkpoint inhibitors: An analysis of the Italian spontaneous reporting system database. [2021]
Immune Checkpoint Inhibitors and Immune-Related Adverse Drug Reactions: Data From Italian Pharmacovigilance Database. [2022]
First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
OX40 Agonist BMS-986178 Alone or in Combination With Nivolumab and/or Ipilimumab in Patients With Advanced Solid Tumors. [2022]