BMS-986416 + Nivolumab for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments: BMS-986416 (an experimental treatment) and Nivolumab (also known as Opdivo, an immunotherapy drug). The aim is to assess their safety and effectiveness for individuals with advanced solid tumors, such as certain lung, liver, and head and neck cancers. Researchers seek to understand how these drugs work both individually and in combination, as well as their early effects on tumors. This trial may suit individuals whose cancer has not responded to standard treatments and who have tumors that can be measured and biopsied. 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who need chronic anticoagulant or antiplatelet agents, except for low-dose aspirin. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BMS-986416 has not caused any new safety issues in earlier studies involving people with solid tumors. The side effects were as expected, with no surprising problems identified.
When combined with Nivolumab, the safety results remain consistent, showing no new concerns. This indicates that the combination is generally well-tolerated. However, as this is a phase 1 study, researchers continue to monitor safety and side effects closely.
Overall, current data suggests that BMS-986416 and its combination with Nivolumab are safe so far, but ongoing studies are essential to confirm these findings. Participants in clinical trials will continue to provide valuable information about the tolerability of these treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about BMS-986416 and its combination with Nivolumab because they represent a novel approach for treating solid tumors. Unlike the standard treatments that often focus on directly attacking cancer cells, BMS-986416 is designed to modulate the immune system, potentially enhancing its ability to fight cancer. When combined with Nivolumab, an established immunotherapy drug, BMS-986416 may enhance the immune response even further, offering a synergistic effect that could improve outcomes. This combination targets the immune checkpoints, providing a new tactic in the fight against cancer, which could lead to more effective and durable responses.
What evidence suggests that this trial's treatments could be effective for solid tumors?
Research has shown that BMS-986416 could be a promising treatment for solid tumors. It targets TGF-β, a protein that aids tumor growth, and may alter the tumor environment. Early results suggest it might slow tumor growth. In this trial, some participants will receive BMS-986416 alone, while others will receive it with Nivolumab, a well-known cancer drug. Nivolumab alone has already proven beneficial in treating other cancers, such as lung cancer. This combination aims to enhance the immune system's ability to fight tumors.12678
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 like lung, bladder, head and neck, liver, colorectal cancer or pancreatic cancer. They must have measurable disease that's resistant to standard treatments and be able to undergo biopsies. People can't join if they have serious heart issues, need blood thinners (except low-dose aspirin), or have specific connective tissue diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986416 alone or in combination with Nivolumab to evaluate safety, tolerability, and preliminary antitumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986416
- Nivolumab
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