Immunotherapy for Melanoma
Trial Summary
What is the purpose of this trial?
This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic steroid therapy or any other form of immunosuppressive therapy, you must stop these at least 7 days before the first dose of the study drug, unless approved by the Principal Investigator.
What data supports the effectiveness of the treatment Nivolumab, Opdivo, OncoSec Medical Electroporation Therapy System, Tavo for melanoma?
Is immunotherapy for melanoma, including treatments like Nivolumab, generally safe for humans?
How does the drug Nivolumab differ from other treatments for melanoma?
Nivolumab is unique because it is a monoclonal antibody that targets the PD-1 receptor on tumor cells, helping the immune system recognize and attack the cancer, unlike traditional chemotherapy which directly kills cancer cells. It is administered intravenously and has shown better survival rates compared to standard chemotherapy for advanced melanoma.611121314
Research Team
Ahmad Tarhini, MD, PhD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
Adults diagnosed with operable advanced melanoma are eligible for this trial. They must have a tumor that can be measured and is suitable for electroporation therapy. Participants should not be pregnant or breastfeeding, agree to use contraception, and have no severe allergies to the drugs being tested. Those with certain infections, immunodeficiencies, other cancers requiring treatment, or recent transfusions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive intratumoral tavo-EP and nivolumab IV infusion over 3 cycles of 4 weeks each
Surgery
Definitive surgery is scheduled 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment
Adjuvant Treatment
Adjuvant therapy with nivolumab monotherapy for up to 9 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivolumab
- OncoSec Medical Electroporation Therapy System
- Tavo
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
OncoSec Medical Incorporated
Industry Sponsor