Anti-LAG-3 + Anti-PD-1 Immunotherapy for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new cancer treatments for safety and effectiveness. It targets individuals with certain solid tumors that have spread or are inoperable. The trial examines the use of two experimental medications, BMS-986016 (Relatlimab) and Nivolumab (Opdivo), either alone or in combination, to assess their impact on tumors such as lung, gastric, liver, kidney, bladder, skin, and head and neck cancers. Suitable candidates have these cancers and have not responded to other treatments. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to receive potentially groundbreaking therapies.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether 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 has shown that the combination of the drugs relatlimab and nivolumab, used in this study, has generally been well-tolerated by cancer patients. In earlier trials, about 74% of patients experienced some treatment-related side effects, most of which were mild. More serious side effects, known as high-grade events, occurred in about 38% of cases.
Specific side effects included liver inflammation (hepatitis) and problems with hormone production (adrenal insufficiency), observed in 2.8% of patients.
This combination treatment has already been used to treat advanced melanoma, a type of skin cancer, and has effectively shrunk tumors. This previous use in humans provides some confidence in its safety.
Overall, while some risks exist, the treatment has shown promise in being manageable for patients.12345Why are researchers excited about this trial's treatments?
Most treatments for cancer work by targeting specific proteins on cancer cells, but Relatlimab and Nivolumab are breaking new ground by focusing on different immune checkpoints. Relatlimab targets LAG-3, a protein that can suppress the immune response, while Nivolumab targets PD-1, another protein that helps cancer cells evade the immune system. By combining these two, researchers hope to unleash a more robust immune attack on cancer cells. This dual-action approach is showing promise because it potentially enhances the body's ability to recognize and destroy cancer cells more effectively than treatments targeting only one checkpoint.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that the combination of the drugs relatlimab and nivolumab, which participants in this trial may receive, yields promising results for treating advanced melanoma, a type of skin cancer. Studies have found that this treatment helps patients live longer without their cancer worsening. In some cases, the percentage of patients whose cancer shrinks or disappears is similar to other effective treatments. Long-term studies have demonstrated lasting benefits of this combination therapy compared to using nivolumab alone. While most data comes from melanoma patients, the treatment might also benefit other types of solid tumors in this trial.25678
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 solid tumors (like lung, stomach, liver cancer and more) that have spread or can't be surgically removed. Participants must not have tried immuno-oncology drugs before, except for specific cases in melanoma and lung cancer. They should be relatively healthy otherwise and have at least one measurable tumor.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986016 alone or in combination with nivolumab for the treatment of advanced solid tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986016
- Nivolumab
- Relatlimab
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