APX005M + Nivolumab + Ipilimumab for Melanoma
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires that any prior small molecule inhibitors be stopped at least 2 weeks before starting the study. If you are on corticosteroids, you must be off them for at least 2 weeks unless you are on a low dose for adrenal insufficiency. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the drug combination APX005M, Nivolumab, and Ipilimumab for treating melanoma?
Is the combination of APX005M, Nivolumab, and Ipilimumab safe for humans?
The combination of Nivolumab and Ipilimumab, used for treating melanoma, is associated with a higher risk of immune-related side effects, which can be severe but are often reversible with treatment. Close monitoring and experienced management are necessary to handle these side effects effectively.678910
What makes the drug combination of APX005M, Nivolumab, and Ipilimumab unique for treating melanoma?
What is the purpose of this trial?
This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.
Research Team
Harriet Kluger, MD
Principal Investigator
Yale University
Sarah Weiss, MD
Principal Investigator
Yale University
Kelly Olino, MD
Principal Investigator
Yale University
Eligibility Criteria
Adults with advanced melanoma or RCC, who haven't had systemic immune therapy for their condition. They must be in good health, have a life expectancy of at least 6 months, and agree to use effective contraception. Those with stable brain metastases may qualify; however, individuals with certain heart conditions, active infections requiring IV antibiotics, or recent participation in other clinical trials are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M for 4 cycles
Maintenance Treatment
Participants receive nivolumab 360mg and APX005M every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- APX005M
- Ipilimumab
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Apexigen America, Inc.
Industry Sponsor
Apexigen, Inc.
Industry Sponsor