BMS-986258 + Nivolumab for Cancer

No longer recruiting at 34 trial locations
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Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Bristol-Myers Squibb
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 explores whether BMS-986258, an experimental treatment, alone or combined with Nivolumab (Opdivo, an immunotherapy drug), is safe and tolerable for people with advanced cancer. It targets individuals with certain difficult-to-treat cancers, such as lung, breast, or kidney cancer, who have tried at least one other treatment without success. Participants must have a diagnosis of one of these specific cancers and have experienced cancer progression or intolerance to previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications, but it mentions that at least 4 weeks must pass since your last dose of any prior anti-cancer therapy before starting the study treatment.

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

Previous studies have shown that BMS-986258, both alone and with Nivolumab, is generally safe and well-tolerated. Both treatments are used in cancer therapy, and Nivolumab is already approved for treating various cancers, indicating its safety is well-understood. Early research on BMS-986258 indicates it is usually safe when used alone or with Nivolumab. Major reports of serious side effects have not emerged, making these treatments promising options for those considering joining clinical trials.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about BMS-986258 and its combination with Nivolumab because these treatments offer a novel approach to fighting cancer. BMS-986258 is a unique compound that works by targeting specific pathways involved in tumor growth and immune evasion, a mechanism not commonly addressed by existing therapies. When combined with Nivolumab, an established immune checkpoint inhibitor that unleashes the body's immune system against cancer cells, there's potential for a powerful synergy that could enhance treatment effectiveness. This combination aims to boost the immune response against tumors more effectively than current standard treatments, offering hope for improved outcomes in cancer therapy.

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

Research has shown that BMS-986258 targets TIM-3, a molecule that can promote cancer growth by weakening the immune system. Lab tests have demonstrated that blocking TIM-3 slows tumor growth and enhances the immune system's ability to fight cancer. In this trial, some participants will receive BMS-986258 alone, while others will receive it with Nivolumab, a drug that helps the immune system recognize and attack cancer cells. Previous studies with Nivolumab have shown it can reduce the risk of cancer worsening or causing death in some patients. Together, these treatments aim to strengthen the body's ability to combat cancer.13678

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 certain advanced cancers (kidney, colorectal, lung, head and neck, or triple-negative breast cancer) that have spread or can't be removed by surgery. Participants must have tried at least one standard treatment without success and should be in good physical condition. Women of childbearing potential must agree to use contraception.

Inclusion Criteria

I have one of the specified cancers that can't be removed or has spread, with measurable disease.
My cancer returned or worsened after at least one standard treatment.
Women must agree to follow specific methods of contraception, if applicable
See 1 more

Exclusion Criteria

It's been over 4 weeks since my last cancer treatment.
I have an autoimmune disease.
I have another cancer that needs treatment at the same time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986258 alone or in combination with Nivolumab to assess safety and tolerability

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-986258
  • Nivolumab
Trial Overview The study is testing the safety and tolerability of BMS-986258 alone and when combined with Nivolumab in treating advanced cancers. It aims to see how well these therapies work on their own or together against different solid tumors.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Part C Cohort Expansion: BMS-986258 + nivolumabExperimental Treatment2 Interventions
Group II: Part B Dose Escalation: BMS-986258 + nivolumabExperimental Treatment2 Interventions
Group III: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)Experimental Treatment2 Interventions
Group IV: Part A Dose Escalation: BMS-986258Experimental 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

Citations

An Investigational Immunotherapy Study of BMS-986258 ...The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of ...
T cell Immunoglobulin and Mucin Domain Containing ...TIM-3 is a promising target as a treatment for cancer. Both monotherapy and combination regimens are being developed and are currently under investigation.
TIM-3 blockade in diffuse intrinsic pontine glioma models ...We show that inhibition of TIM-3 in syngeneic models of DIPG prolongs survival and produces long-term survivors free of disease that harbor immune memory.
Tim-3 finds its place in the cancer immunotherapy landscapeCoblockade of Tim-3 and PD-1 can result in reduced tumor progression in preclinical models and can improve antitumor T-cell responses in cancer patients.
OncoResponse reports data of Phase I solid tumour ...OncoResponse has unveiled the outcomes from the Phase I trial of OR502 for treating advanced solid tumours ... LOA and PTSR Model - BMS-986258 in ...
BMS to cancel Phase III trial of colorectal cancer therapyBristol-Myers Squibb (BMS) has announced that it will discontinue a Phase III trial of nivolumab plus relatlimab to treat mCRC patients.
EC approves BMS' nivolumab SC formulation for solid ...Data showed comparable safety and pharmacokinetics (PK) between the therapy's IV and SC formulations. The safety profile of the SC version of ...
Exploring treatment options in cancer: tumor ...An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are ...
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