APX005M + Nivolumab + Ipilimumab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments—APX005M (an experimental treatment), nivolumab, and ipilimumab—to determine their effectiveness for advanced melanoma, a serious type of skin cancer. Researchers aim to assess the safety and efficacy of these drugs when used together. The trial is open to individuals with advanced melanoma who have not previously received immune therapy for this condition. Participants must be willing to undergo a tumor biopsy (a sample of the cancer is taken) as part of the study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
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 there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that combining nivolumab and ipilimumab led to more side effects, but no new safety concerns or treatment-related deaths occurred. APX005M, when used alone, was also safe for people with advanced melanoma. Another study showed that APX005M, when combined with a personal cancer vaccine or with nivolumab and ipilimumab, was safe to use.
These findings suggest that using APX005M with nivolumab and ipilimumab is generally well-tolerated, although side effects can occur. No unexpected safety issues have emerged, which is reassuring for those considering joining the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for melanoma because APX005M, when combined with nivolumab and ipilimumab, offers a new approach to fighting cancer. Unlike the standard treatments that primarily focus on inhibiting specific checkpoints like PD-1 and CTLA-4, APX005M targets CD40, a protein that can activate the immune system to attack cancer cells more effectively. Additionally, the combination of these three drugs may enhance the immune response more than existing therapies, potentially leading to better outcomes for patients. This innovative combination aims to boost the body's natural defenses against melanoma, offering hope for improved treatment efficacy.
What evidence suggests that this trial's treatments could be effective for advanced melanoma?
This trial will evaluate the combination of APX005M, nivolumab, and ipilimumab for treating advanced melanoma. Research has shown that using nivolumab and ipilimumab together effectively treats advanced melanoma, a type of skin cancer, and helps patients live longer. In this trial, APX005M is added to potentially strengthen the immune system in patients with solid tumors. This combination has also helped patients whose previous treatments failed, either by shrinking the tumor or controlling the disease. While more research is needed to fully understand its benefits, early results are promising for those with advanced melanoma.23567
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