Pembrolizumab for Desmoplastic Melanoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of pembrolizumab, an immunotherapy drug, in treating desmoplastic melanoma, a rare type of skin cancer. The trial includes two groups: one for patients whose cancer can be surgically removed and another for those whose cancer cannot be removed. Pembrolizumab may help the immune system attack cancer cells and stop their growth. Patients with this type of melanoma who have not previously received systemic treatment and meet specific health criteria might be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering patients a chance to contribute to important advancements in cancer therapy.
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.
Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?
Research has shown that pembrolizumab is generally well-tolerated by people with desmoplastic melanoma. In one study, 89% of patients with melanoma that couldn't be removed by surgery responded to the treatment, with most experiencing tumor shrinkage. About 37% of these patients had a complete response, where their cancer was no longer detectable.
Regarding safety, another study examined the side effects of pembrolizumab and found the treatment to be generally safe, with most side effects being manageable. While some people may experience side effects, they are usually not severe and can often be treated without stopping the medication.
Overall, pembrolizumab has shown promising results in both effectiveness and safety for treating desmoplastic melanoma.12345Why do researchers think this study treatment might be promising for melanoma?
Researchers are excited about pembrolizumab for desmoplastic melanoma because it leverages the power of immunotherapy. While traditional treatments often involve surgery, chemotherapy, or radiation, pembrolizumab is a monoclonal antibody that enhances the immune system's ability to recognize and destroy cancer cells. This treatment specifically targets the PD-1/PD-L1 pathway, which tumors use to hide from the immune system, making it a promising option for patients with unresectable or advanced forms of the disease. By potentially offering a less invasive and more targeted approach, pembrolizumab could represent a significant advancement in melanoma treatment.
What evidence suggests that pembrolizumab might be an effective treatment for desmoplastic melanoma?
Research shows that pembrolizumab effectively treats desmoplastic melanoma, a rare type of skin cancer. Studies have found that 89% of patients experienced a positive response, with tumors either shrinking or disappearing. Notably, 37% of patients saw their tumors completely vanish. This treatment aids the body's immune system in attacking and destroying cancer cells. In this trial, participants in Cohort A will receive pembrolizumab and may undergo surgery if their cancer is potentially resectable. Participants in Cohort B will receive pembrolizumab for unresectable disease. These strong results suggest that pembrolizumab could be a powerful option for people with desmoplastic melanoma, regardless of whether the cancer can be surgically removed.14567
Who Is on the Research Team?
Kari L Kendra
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
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:
- 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