Pembrolizumab + Ipilimumab/Nivolumab for Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments for melanoma, a type of skin cancer that can spread to other parts of the body. Researchers aim to determine if these treatments, administered before surgery, can improve survival rates without requiring additional treatment afterward. Participants will receive either pembrolizumab (an immunotherapy drug) or a combination of ipilimumab and nivolumab (both immunotherapy drugs) before lymph node removal. The trial seeks individuals with stage IIIB or IVa melanoma that can be surgically removed and who have not previously received similar treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown pembrolizumab to be generally safe. Common side effects, such as tiredness, diarrhea, rash, and nausea, affect more than 20% of patients but are usually manageable. The FDA has already approved pembrolizumab for other uses, indicating its relative safety.
Research on the combination of ipilimumab and nivolumab suggests these treatments can also be safe, though they might cause stronger side effects. This combination boosts the immune system to fight cancer, potentially leading to immune-related side effects. Patients may experience symptoms like skin rash, diarrhea, and tiredness, which are generally manageable with medical assistance.
Overall, both treatment options have undergone safety studies. While they can cause side effects, these are typically manageable with proper care.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of pembrolizumab, ipilimumab, and nivolumab for treating melanoma because these drugs offer a unique approach to boosting the immune system's ability to fight cancer. Unlike traditional chemotherapy, which directly targets and kills cancer cells, these treatments are immune checkpoint inhibitors. Pembrolizumab blocks the PD-1 pathway, while ipilimumab and nivolumab target CTLA-4 and PD-1, respectively, helping the immune system recognize and attack melanoma cells more effectively. This mechanism can potentially lead to more durable and long-lasting responses compared to existing treatments. Additionally, the combination strategy aims to enhance the effectiveness of immunotherapy, potentially offering new hope for patients with advanced melanoma.
What evidence suggests that this trial's treatments could be effective for melanoma?
Research has shown that pembrolizumab, administered to participants in Arm A of this trial, effectively treats melanoma. Studies have found it prevents cancer from worsening by over 43% compared to chemotherapy. Additionally, it has been associated with a median overall survival of 23.8 months in patients with melanoma that cannot be surgically removed or has spread.
Participants in Arm B will receive a combination of ipilimumab and nivolumab, also supported by data as an effective treatment for melanoma that cannot be surgically removed or has spread. This combination is often used when other treatments are insufficient. While specific survival rates for this combination are not detailed, its role in advanced melanoma care is well-established. Both treatment options in this trial show promise for managing melanoma, with strong evidence supporting the effectiveness of pembrolizumab.678910Who Is on the Research Team?
Stergios Moschos, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with stage IIIB to M1a melanoma (skin cancer) that can be surgically removed, including cases where the original tumor site is unknown. Participants must be at high risk of relapse after lymph node surgery and have not received prior adjuvant therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant PD-1-based treatment regimens. Arm A: Pembrolizumab 200 mg IV every 3 weeks for 2 infusions. Arm B: Ipilimumab plus nivolumab for one infusion, followed by nivolumab 240 mg IV 3 weeks later.
Surgery
Participants undergo lymph node dissection following neoadjuvant treatment.
Follow-up
Participants are monitored for event-free survival at 12 months and overall survival at 24 months after the first neoadjuvant treatment infusion.
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
- Pembrolizumab
Trial Overview
The study compares two pre-surgery (neoadjuvant) treatments: either two doses of pembrolizumab or one dose of ipilimumab plus nivolumab followed by a single dose of nivolumab. Patients are randomly assigned to each group and monitored for survival outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) x one infusion, followed by a single infusion of nivolumab 240 mg IV 3 weeks later, followed by lymph node dissection, followed by no adjuvant treatment
Participants receive pembrolizumab 200 mg IV, every 3 weeks, times 2 infusions followed by lymph node dissection, followed by no adjuvant treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Citations
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Safety in ...
In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC ...
YERVOY U.S. Prescribing Information
ipilimumab in combination with nivolumab. For other indications, the effects of anti-drug antibodies on effectiveness have not been fully characterized. 13.
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