Nivolumab + Immunotherapy for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and feasibility of combining Nivolumab (an immunotherapy drug) with either Ipilimumab or Relatlimab to treat melanoma that has spread to the brain. The treatment involves administering a single dose of these drugs before surgery to remove brain tumors. Individuals with melanoma that has spread to the brain, who require surgery but can wait briefly, may be suitable candidates. As an Early 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 innovative therapy.
Do I have to stop taking my current medications for the trial?
The trial allows some medications, like BRAF MEK inhibitors, if stopped at least a week before starting the study treatment. However, it doesn't specify all medications you might be taking, so it's best to discuss your current medications with the trial team to see if any need to be paused or adjusted.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and relatlimab is generally well-tolerated by patients with melanoma. In some studies, about 0.4% of patients experienced treatment-related deaths due to serious issues like digestive system bleeding and heart problems, though these severe side effects are rare.
For the combination of nivolumab and ipilimumab, safety data is also reassuring. Previous studies have shown that the safety results align with earlier trials. Both nivolumab and ipilimumab are already approved for treating advanced melanoma, indicating a well-established safety record.
Overall, while there is a risk of serious side effects, past research generally considers these treatments safe. It is crucial to discuss any concerns with a healthcare provider before joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments being explored for melanoma because they combine innovative immunotherapy approaches. Nivolumab, when paired with Relatlimab (Opdualag), introduces a new mechanism by targeting both PD-1 and LAG-3 pathways, potentially enhancing the immune system's response against cancer cells. Meanwhile, the combination of Nivolumab and Ipilimumab utilizes a different strategy by targeting PD-1 and CTLA-4 pathways, which might offer a more robust attack on the tumor. Both combinations aim to enhance immune activation more effectively than traditional treatments that typically focus on a single pathway. These approaches could lead to more efficient tumor reduction before surgery, offering hope for improved outcomes in melanoma care.
What evidence suggests that this trial's treatments could be effective for melanoma with brain metastases?
Research shows that using nivolumab with relatlimab, a treatment option in this trial, holds promise for advanced melanoma. Studies have found that this combination can extend the time patients live without their cancer worsening, meaning the cancer didn't grow or spread as quickly compared to standard treatments.
Similarly, the combination of nivolumab and ipilimumab, another option in this trial, has demonstrated strong results for melanoma treatment. Long-term studies report that more than half of the patients treated with this combination were still alive after five years, a significant improvement over using ipilimumab alone. Both combinations offer hope for people dealing with melanoma.12346Who Is on the Research Team?
Peter Forsyth, MD
Principal Investigator
Moffitt Cancer Center
Yolanda Pina, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with melanoma brain metastases who can have surgery to remove these metastases. They must not have had immunotherapy in the last 6 months, be willing to provide samples for research, and meet certain health criteria including organ function and performance status. Women of childbearing potential must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of Nivolumab with either Ipilimumab or Relatlimab prior to surgery for tumor resection
Surgery
Participants undergo standard of care surgery for tumor resection 7-10 days after receiving the study drug
Follow-up
Participants are monitored for safety and effectiveness after treatment and surgery
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Nivolumab + Relatlimab
- Standard of Care Craniotomy
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Bristol-Myers Squibb
Industry 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