Opdualag vs Nivolumab for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments for individuals with high-risk basal cell carcinoma (BCC), a type of skin cancer. It evaluates the effectiveness of a combination of Nivolumab and Relatlimab (Opdualag) versus Nivolumab alone before surgery. The trial targets individuals with large BCCs located on the head, neck, or body, where surgery might cause noticeable changes or require complex procedures. Ideal candidates have not received prior treatment for their BCC. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain treatments like corticosteroids above a specific dose or other immunosuppressive medications within 30 days before starting the trial.
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, known as Opdualag, yields promising results. One study found that Opdualag reduced the risk of cancer progression by 25% compared to nivolumab alone, suggesting its effectiveness.
In terms of safety, Opdualag is generally well-tolerated. However, like any treatment, it can cause side effects. Common side effects for similar treatments include tiredness, skin rash, and joint pain, which are often mild but can occasionally be more severe.
Nivolumab alone is also considered safe. It has been used in other conditions, and studies have shown it can lead to high survival rates. As with Opdualag, side effects may include tiredness and rash, but these are usually manageable.
Since this trial is in an early phase, the treatment has been tested for safety in smaller groups and is still under study to ensure its safety and effectiveness for a broader population. Always discuss any concerns with a healthcare provider before deciding to join a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments being studied for skin cancer because they offer a fresh approach compared to current options like chemotherapy and traditional immunotherapies. Nivolumab, an immune checkpoint inhibitor, helps activate the immune system to attack cancer cells more effectively. When combined with Relatlimab, which targets a different immune checkpoint called LAG-3, this combo has the potential to enhance the immune response even further. This dual-action makes the treatment promising because it may improve effectiveness and provide new hope for patients who haven't responded well to existing therapies.
What evidence suggests that this trial's treatments could be effective for high risk BCC?
In this trial, participants will receive either the combination of nivolumab and relatlimab (Opdualag) or nivolumab alone. Earlier studies have shown promising results for the combination in treating advanced melanoma, a type of skin cancer. Research indicates that this combination can reduce the risk of cancer progression by 25% compared to nivolumab alone. Additionally, most patients who received this combination treatment remained alive and disease-free four years later. Nivolumab alone has also proven effective, with about 44% of patients surviving five years in some studies. These findings suggest that both treatments could effectively manage high-risk skin cancers.26789
Who Is on the Research Team?
Soo Park, MD
Principal Investigator
UC San Diego Health - Moores Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a specific skin cancer called high-risk basal cell carcinoma (HR BCC) that's big enough to need surgery and might cause cosmetic or functional issues. Participants must be treatment-naive, able to understand the study, and sign consent. They should also have good physical function and adequate blood cell counts.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive 4 cycles of neoadjuvant Opdualag or Nivolumab every 4 weeks, with an option to proceed to surgery after 2 cycles if there is disease progression.
Surgical Resection
Surgical resection is performed after treatment cycles, unless a clinical complete response is observed.
Follow-up
Participants are monitored for disease recurrence and other secondary outcomes.
Extension
Option to continue with Opdualag or Nivolumab beyond 4 cycles if there is ongoing clinical benefit.
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Relatlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
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