APX005M + Nivolumab + Ipilimumab for Melanoma
What You Need to Know Before You Apply
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.
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.
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.12345
What makes the drug combination of APX005M, Nivolumab, and Ipilimumab unique for treating melanoma?
What data supports the effectiveness of the drug combination APX005M, Nivolumab, and Ipilimumab for treating melanoma?
Who Is on the Research Team?
Harriet Kluger, MD
Principal Investigator
Yale University
Sarah Weiss, MD
Principal Investigator
Yale University
Kelly Olino, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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