BMS-986525 + Nivolumab for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new drug, BMS-986525 (an experimental treatment), both alone and combined with Nivolumab (an immunotherapy drug), for individuals with small cell lung cancer that has recurred or resisted treatment. The trial aims to assess the effectiveness of these treatments together at different doses. It includes various parts, with some participants receiving only BMS-986525 and others receiving both drugs. Eligible participants have small cell lung cancer that has returned or is resistant to treatment and have undergone at least one platinum-based chemotherapy. As a Phase 1 trial, this 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 have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that BMS-986525, both alone and with Nivolumab, is being tested for safety and tolerability. Some studies indicate that researchers monitor serious side effects and dosage issues in participants over about two years.
BMS-986525 is a new drug, so detailed safety information is still being collected. However, Nivolumab is already approved for other cancer treatments, and its safety profile is well understood. Doctors know how it works in the body and the types of side effects it might cause.
For those considering joining the trial, it's important to know that the current research focuses on understanding the safety of these treatments. Researchers closely monitor participants' health and any side effects to ensure the treatment is as safe as possible.12345Why are researchers excited about this trial's treatments?
Researchers are excited about BMS-986525, especially in combination with Nivolumab, because it offers a fresh approach to treating small cell lung cancer. Many existing treatments for this condition, like chemotherapy and radiation, work by attacking rapidly dividing cells, but they often come with significant side effects. BMS-986525 is unique because it acts on specific pathways involved in cancer cell growth, potentially offering a more targeted approach. When combined with Nivolumab, an immunotherapy that boosts the immune system's ability to fight cancer, there's hope for a more effective and less toxic treatment option. This combination could provide a new lifeline for patients who haven’t responded well to traditional therapies.
What evidence suggests that this trial's treatments could be effective for Small Cell Lung Cancer?
Research shows that BMS-986525 is a new experimental drug under testing for small cell lung cancer. Although limited information exists on its standalone effectiveness, studies are assessing its safety and patient tolerance. In this trial, some participants will receive BMS-986525 as monotherapy, while others will receive a combination of BMS-986525 and Nivolumab. Nivolumab, an approved treatment, helps the immune system fight cancer and has been effective in treating various cancers, including lung cancer. Researchers are examining whether using BMS-986525 and Nivolumab together might outperform their separate use. Early results suggest that combining treatments could more effectively attack cancer cells. However, more research is needed to confirm the effectiveness of this combination for small cell lung cancer.13456
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 people with relapsed/refractory small cell lung cancer who have already tried at least one platinum-based chemotherapy. It's open to those who can't get or haven't had success with anti-PD-(L)1 therapy, which is a type of immunotherapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986525 alone or in combination with Nivolumab in dose escalation and expansion phases
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986525
- Nivolumab
Trial Overview
The study tests the safety and how well patients tolerate BMS-986525 alone and when combined with Nivolumab, another immunotherapy drug. The goal is to see if these treatments are safe for people whose lung cancer has come back or hasn't responded to other treatments.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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
Citations
A Study to Assess the Safety and Tolerability of BMS ...
Participation Criteria · Participants must have histologically or cytologically documented relapsed/refractory small cell lung cancer (R/R-SCLC).
BMS-986525 + Nivolumab for Small Cell Lung Cancer
This trial is for people with relapsed/refractory small cell lung cancer who have already tried at least one platinum-based chemotherapy. It's open to those who ...
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theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/BMY/pressreleases/36970716/bristol-myers-squibb-adds-new-immunotherapy-combo-bet-in-small-cell-lung-cancer/Bristol Myers Squibb Adds New Immunotherapy Combo ...
BMS-986525 is an experimental cancer medicine given by itself or with nivolumab. Nivolumab is BMY's approved immunotherapy used in several ...
Trial ID CA209-331 | NCT02481830 - BMS Clinical Trials
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
A Study to Assess the Safety and Tolerability of BMS ...
The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Nivolumab in participants with ...
A Study to Assess the Safety and Tolerability of BMS ...
Number of participants with serious adverse events (SAEs), Up to approximately 2 years ; Number of participants with AEs meeting dose-limiting toxicity (DLT) ...
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