Pre- and Post-Surgery Pembrolizumab for Melanoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not receive any other biologic therapy, hormonal therapy, or chemotherapy while on the study. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug pembrolizumab for melanoma?
Pembrolizumab has been shown to improve treatment outcomes in advanced melanoma compared to another drug, ipilimumab, and has been approved for use in advanced melanoma cases. Additionally, in a trial for resected stage III melanoma, pembrolizumab improved recurrence-free survival compared to a placebo.12345
Is pembrolizumab safe for use in humans?
Pembrolizumab (also known as KEYTRUDA or MK-3475) has been approved by the FDA for the treatment of melanoma and has been studied in other cancers like lung cancer. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related side effects can include lung inflammation, liver inflammation, and thyroid issues. Overall, the benefits of pembrolizumab in treating life-threatening conditions have been found to outweigh these risks.13678
How is the drug pembrolizumab unique for treating melanoma?
Pembrolizumab is unique because it is a PD-1 inhibitor that helps the immune system attack cancer cells by blocking a pathway that usually keeps immune cells from attacking them. It is used both before and after surgery for melanoma, which is different from many treatments that are only used after surgery.135910
What is the purpose of this trial?
This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.
Research Team
Sapna P Patel
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
This trial is for adults with high-risk melanoma (stage III-IV) that can be removed by surgery. They must not have had previous neoadjuvant immunotherapy or certain other treatments, no active infections, and no history of severe autoimmune disease or pneumonitis. Participants need functioning major organs, no brain metastases, and women of childbearing age must test negative for pregnancy.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive pembrolizumab IV every 3 weeks for 3 cycles before surgery
Surgery
Participants undergo surgical resection
Adjuvant Treatment
Participants receive pembrolizumab IV every 3 weeks for 15 cycles after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
- Therapeutic Conventional Surgery
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor