Pembrolizumab for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). 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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients must not be on active immunosuppression, which might imply some restrictions on certain medications. It's best to discuss your specific medications with the trial team.
Is pembrolizumab safe for humans?
Pembrolizumab, also known as KEYTRUDA, has been studied for safety in patients with melanoma and other cancers. Common side effects include fatigue, cough, nausea, itching, rash, decreased appetite, joint pain, and diarrhea. Some patients may experience immune-related side effects like lung inflammation, liver inflammation, and thyroid issues.12345
How is the drug pembrolizumab unique for treating skin cancer?
Pembrolizumab is unique because it is a PD-1 inhibitor that helps the immune system attack cancer cells by blocking a pathway that usually stops immune cells from working effectively. This drug has shown durable antitumor activity in various cancers, including skin cancer, with manageable side effects.45678
Who Is on the Research Team?
Janice Mehnert
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
Adults with stage I-IIIb Merkel cell carcinoma, surgically removed within the past 16 weeks. Must have stable blood counts and organ function, no HIV or hepatitis unless under control. Not for those with distant metastases, history of other cancers in last two years (except certain skin cancers), or recent immunotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab IV every 21 days for up to 17 cycles or undergo standard of care observation
Radiation
Participants may undergo standard of care radiation therapy within 14 days of day 1, cycle 1
Follow-up
Participants are monitored for recurrence free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor