Pembrolizumab for Desmoplastic Melanoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot receive other cancer treatments or certain medications like systemic corticosteroids within 14 days before joining the trial.
What data supports the effectiveness of the drug pembrolizumab for treating desmoplastic melanoma?
Is pembrolizumab safe for humans?
Pembrolizumab, also known as Keytruda, has been shown to be generally safe in humans, with common side effects including fatigue, rash, itching, and diarrhea. Some less common side effects can affect the immune system, such as inflammation of the lungs (pneumonitis), liver (hepatitis), or thyroid gland (hypothyroidism or hyperthyroidism).16789
How is the drug pembrolizumab unique in treating desmoplastic melanoma?
Pembrolizumab is unique because it is a monoclonal antibody that targets the PD-1 receptor on T cells, helping the immune system attack cancer cells more effectively. It has shown high response rates in melanoma with minimal side effects, making it a promising option compared to traditional treatments.123610
What is the purpose of this trial?
This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can be removed by surgery (resectable) or cannot be removed by surgery (unresectable). 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.
Research Team
Kari L Kendra
Principal Investigator
SWOG Cancer Research Network
Eligibility Criteria
Adults with desmoplastic melanoma, a type of skin cancer, that can either be surgically removed or not. Participants must not have had prior treatments for this cancer or certain other therapies and drugs recently. They should not have active infections, autoimmune diseases needing recent treatment, or untreated brain metastases. Women who can bear children must test negative for pregnancy and agree to use contraception.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Cohort A)
Participants receive pembrolizumab intravenously every 21 days for up to 3 cycles, followed by surgery if disease is resectable
Treatment (Cohort B)
Participants with unresectable disease receive pembrolizumab intravenously every 21 days for up to 34 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pembrolizumab
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