Axitinib + Nivolumab for Melanoma
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic treatments like corticosteroids or immunosuppressive medications, you may need to stop them 14 days before starting the trial drugs.
What data supports the effectiveness of the drug combination Axitinib and Nivolumab for treating melanoma?
Research shows that Nivolumab, a part of the combination, has demonstrated long-term survival benefits for advanced melanoma patients. Additionally, combining Nivolumab with another drug, Ipilimumab, has shown significant improvements in patient response and survival compared to using Ipilimumab alone.12345
What safety information is available for the combination of Axitinib and Nivolumab in treating melanoma?
Nivolumab, used alone or in combination with other drugs, has been associated with side effects like fatigue, diarrhea, and skin reactions such as psoriasis. When combined with other treatments, it may increase the risk of immune-related side effects, but more studies are needed to fully understand its safety profile.678910
How is the drug combination of Axitinib and Nivolumab unique for treating melanoma?
The combination of Axitinib and Nivolumab for melanoma is unique because it pairs a targeted therapy (Axitinib, which inhibits blood vessel growth in tumors) with an immune checkpoint inhibitor (Nivolumab, which helps the immune system attack cancer cells), potentially offering a novel approach compared to existing treatments that often use either type of drug alone.123511
What is the purpose of this trial?
The researchers are doing this study to find out whether the combination of axitinib and nivolumab is an effective and safe treatment for people with advanced or metastatic mucosal melanoma that has not been treated before.The researchers think that a combination of axitinib and nivolumab may help people with this disease because both drugs target and block proteins that play a role in cancer cell survival and growth. The researchers think the drugs may be more effective if given in combination rather than on their own.
Research Team
Alexander Shoushtari
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with advanced mucosal melanoma that hasn't been treated before can join this trial. They should have a certain type of tumor, be in good enough health to perform daily activities (ECOG 0-2), and not be pregnant or breastfeeding. Participants must agree to use two contraception methods if applicable. People with severe allergies to the drugs, autoimmune diseases needing steroids, recent heart issues, or specific blood disorders cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab IV 480mg every 4 weeks plus axitinib 5mg twice daily. Upon progression, SBRT or ipilimumab may be added.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue treatment with nivolumab and axitinib if they show good tolerance and progression
Treatment Details
Interventions
- Axitinib
- Nivolumab
Axitinib is already approved in European Union, United States, United Kingdom for the following indications:
- Renal cell carcinoma
- Advanced renal cell carcinoma
- Advanced renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University