Pembrolizumab + Chemotherapy for Metastatic 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, if you are on systemic steroid therapy or immunosuppressive therapy, you may need to stop or adjust these medications before starting the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination of Pembrolizumab, Carboplatin, and Paclitaxel for treating metastatic melanoma?
Is the combination of pembrolizumab and chemotherapy safe for treating metastatic melanoma?
Pembrolizumab, used in treating metastatic melanoma, is generally well tolerated with common side effects like fatigue, rash, itching, and diarrhea. Less common but serious side effects include inflammation of the lungs (pneumonitis), liver (hepatitis), and thyroid issues. While pembrolizumab is considered safer than traditional chemotherapy, it still carries risks of immune-related side effects.16789
How is the drug pembrolizumab combined with chemotherapy unique for treating metastatic melanoma?
Pembrolizumab is unique because it is an anti-PD-1 therapy that helps the immune system attack cancer cells by blocking a pathway that usually keeps immune cells in check. When combined with chemotherapy drugs like carboplatin and paclitaxel, it offers a novel approach by enhancing the immune response while also directly targeting cancer cells, which may improve outcomes for patients with metastatic melanoma.610111213
What is the purpose of this trial?
This is a multi-center, open-label, Phase II clinical trial evaluating pembrolizumab in combination with carboplatin/paclitaxel as a treatment in unresectable locally advanced or metastatic melanoma.
Research Team
Wilson Miller
Principal Investigator
Jewish General Hospital
Rahima Jamal, MD, PhD
Principal Investigator
CHUM, Hopital Notre-Dame
Eligibility Criteria
This trial is for adults over 18 with unresectable Stage III or metastatic melanoma who haven't had prior treatments for advanced melanoma (except BRAF/MEK inhibitors). Participants must have good organ function, not be pregnant, agree to contraception, and have no active infections like HIV or Hepatitis. Those with certain autoimmune diseases, symptomatic CNS lesions, severe neuropathy, or on immunosuppressants can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab, carboplatin, and paclitaxel every 3 weeks for up to 4 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Paclitaxel
- Pembrolizumab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wilson Miller
Lead Sponsor