Cyclophosphamide + Pembrolizumab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of two drugs, Cyclophosphamide (a chemotherapy drug) and Pembrolizumab (an immunotherapy drug), in treating melanoma, a type of skin cancer. The goal is to determine if this combination benefits individuals with advanced melanoma that cannot be surgically removed. It is most suitable for those whose melanoma has spread, who have not responded to other PD-1/PD-L1 treatments, and who can perform everyday activities independently or with minimal assistance. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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, it mentions that certain treatments like investigational or standard immunotherapy, chemotherapy, or radiation should not be taken within 6-9 weeks of the first dose of the trial therapy. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pembrolizumab, when combined with cyclophosphamide, is generally well tolerated for treating advanced melanoma. Common side effects include fatigue and skin rash, indicating that most people do not experience severe issues.
Pembrolizumab has been used for some time and is approved for other treatments, establishing a known safety record. Cyclophosphamide, administered in smaller, regular doses (known as metronomic dosing), is also considered safe. Studies have examined both drugs separately and together, demonstrating their safe use in people. Participants in the trial will be closely monitored for any side effects.12345Why are researchers excited about this study treatment for melanoma?
Researchers are excited about the combination of Cyclophosphamide and Pembrolizumab for melanoma because it offers a unique approach to treatment. Most treatments for melanoma, like targeted therapies and other immunotherapies, focus on different pathways or mechanisms. Pembrolizumab is a type of immunotherapy known as a checkpoint inhibitor that helps the immune system recognize and attack cancer cells. When combined with Cyclophosphamide, which can modulate the immune environment, this combination may enhance the immune system's ability to fight melanoma more effectively. This synergy could potentially improve outcomes for patients compared to existing therapies.
What evidence suggests that Cyclophosphamide and Pembrolizumab might be an effective treatment for melanoma?
Research has shown that pembrolizumab, a treatment that aids the immune system in fighting cancer, has improved survival rates for individuals with advanced melanoma. Specifically, 34% of patients who received pembrolizumab were alive after 10 years, compared to 23.6% of those treated with ipilimumab. In this trial, participants will receive a combination of pembrolizumab and cyclophosphamide, a chemotherapy drug. Studies suggest this combination could enhance outcomes by boosting the immune system's ability to combat cancer. Overall, early data offers hope that this treatment pair could be more effective for melanoma patients.12367
Who Is on the Research Team?
Warren Chow, MD
Principal Investigator
Chao Family Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults with advanced non-ocular melanoma who've previously had PD-1/PD-L1 therapy can join. They need measurable disease, an ECOG score of 0-2, and a life expectancy over 12 weeks. Participants must have good organ function and agree to contraception. Exclusions include ocular melanoma, severe prior pembrolizumab side effects, untreated brain metastases, certain viral infections, or recent other cancer treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Pembrolizumab 200mg IV every 21 days or 400 mg IV every 42 days and Cyclophosphamide 50mg PO daily on days 1-14 every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor