Ipilimumab + Nivolumab for Melanoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them at least 14 days before starting the study drugs.
What data supports the effectiveness of the drug combination of Ipilimumab and Nivolumab for melanoma?
Is the combination of Ipilimumab and Nivolumab safe for humans?
The combination of Ipilimumab and Nivolumab can cause immune-related side effects, which are often mild to moderate but can be severe in some cases. These side effects are due to the drugs' action on the immune system, and they require careful monitoring and management. While more studies are needed, current data from real-world use and clinical trials suggest that the safety profile includes reactions from each drug when used alone.56789
How is the drug combination of Ipilimumab and Nivolumab unique for treating melanoma?
The combination of Ipilimumab and Nivolumab is unique because it targets two different immune checkpoints, CTLA-4 and PD-1, enhancing the body's immune response against melanoma. This combination has shown better outcomes in terms of response rates and survival compared to using Ipilimumab alone.1341011
What is the purpose of this trial?
This study will help determine whether 2 doses of the combination (ipilimumab + nivolumab) is sufficient for patients with early benefit compared to the usual way of trying to give 4 doses. If patients do not show early benefit after 2 doses, patients will be able to continue with additional ipilimumab + nivolumab, even beyond the standard 4 doses if felt in the best interest of the patient.
Research Team
Michael A. Postow
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for adults with unresectable stage III or IV melanoma who haven't had CTLA-4 or PD-1/PD-L1 therapy. They must have a life expectancy of at least 4 months, be in good physical condition (ECOG 0-1), and women must use effective contraception. Exclusions include severe allergies, mental impairments, other serious illnesses, active autoimmune diseases requiring steroids or immunosuppressants, certain neuropathies, another active cancer, known immunodeficiency or viral hepatitis.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants receive 2 doses of ipilimumab 3mg/kg + nivolumab 1mg/kg every 3 weeks
Response Assessment
Participants are assessed for antitumor effect by RECIST at week 6
Maintenance Treatment
Participants with favorable response receive maintenance nivolumab 480mg every 4 weeks for 2 doses
Extended Treatment
Participants without favorable response receive additional ipilimumab + nivolumab every 3 weeks, reassessed at week 12
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ipilimumab and Nivolumab Combination Immunotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
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