17 Participants Needed

Immunotherapy for Melanoma

DD
Overseen ByDeanryan Deaquino
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that Nivolumab (also known as Opdivo) is effective in treating advanced melanoma, with studies demonstrating long-term survival benefits and improved response rates when used alone or in combination with other treatments.12345

Is immunotherapy for melanoma, including treatments like Nivolumab, generally safe for humans?

Nivolumab, used for treating melanoma, has been shown to be generally safe, but it can cause side effects like fatigue, diarrhea, and rash. When combined with other drugs like ipilimumab, it may lead to more serious immune-related side effects, so careful monitoring is important.678910

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 | Moffitt

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

My cancer can be measured and has at least one clear tumor.
My melanoma has spread to nearby lymph nodes, confirmed by tests.
My melanoma has returned in the lymph nodes, confirmed by a biopsy.
See 16 more

Exclusion Criteria

Participants with electronic pacemakers or defibrillators
Participants who have Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies at Screening). HIV testing at screening is not required unless considered clinically indicated by the treating physician
I still have side effects from previous treatments that are not mild.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive intratumoral tavo-EP and nivolumab IV infusion over 3 cycles of 4 weeks each

12 weeks
3 cycles with multiple visits per cycle

Surgery

Definitive surgery is scheduled 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment

2-4 weeks

Adjuvant Treatment

Adjuvant therapy with nivolumab monotherapy for up to 9 cycles

36 weeks
9 cycles with visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Nivolumab
  • OncoSec Medical Electroporation Therapy System
  • Tavo
Trial OverviewThe study tests a combination of intratumoral tavo-EP (a type of gene therapy delivered through electroporation) and nivolumab (an IV infusion). It's an open-label Phase 2 trial where all participants receive the same experimental treatment before surgery to remove their melanoma.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant TreatmentExperimental Treatment3 Interventions
Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion). Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist. Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸
Approved in United States as Opdivo for:
  • 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
🇪🇺
Approved in European Union as Opdivo for:
  • 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
🇨🇦
Approved in Canada as Opdivo for:
  • 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
🇨🇭
Approved in Switzerland as Opdivo for:
  • 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

Trials
576
Recruited
145,000+

OncoSec Medical Incorporated

Industry Sponsor

Trials
11
Recruited
360+

Findings from Research

Nivolumab is shown to be the most cost-effective treatment option for advanced melanoma patients in England, with incremental cost-effectiveness ratios of £24,483 for BRAF mutation-negative and £17,362 for mutation-positive patients.
The analysis utilized a Markov state-transition model based on patient-level data from clinical trials, indicating that nivolumab provides long-term survival benefits while being economically favorable compared to other treatments.
The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England.Meng, Y., Hertel, N., Ellis, J., et al.[2020]
Nivolumab (Opdivo) monotherapy led to complete regression of local recurrence and multiple lung metastases in a patient with recurrent skin melanoma and a positive BRAF mutation, demonstrating its efficacy as a treatment option.
After 5 courses of nivolumab, the patient experienced significant improvement in her condition, achieving an ECOG performance status of 0, indicating a return to an active lifestyle without pain, and normal serum LDH levels.
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)].Samsonia, M., Kandelaki, M., Gibradze, O., et al.[2021]
Pembrolizumab and nivolumab are effective PD-1 inhibitors for treating metastatic melanoma, showing objective response rates of 26-38% and 31-40% respectively in patients who did not respond to previous treatments.
Both therapies have an acceptable safety profile, with most treatment-related side effects being mild (grade 1 or 2) and manageable, making them viable options for patients with treatment-refractory melanoma.
Pembrolizumab and nivolumab: PD-1 inhibitors for advanced melanoma.Ivashko, IN., Kolesar, JM.[2022]

References

The cost-effectiveness of nivolumab monotherapy for the treatment of advanced melanoma patients in England. [2020]
2.Georgia (Republic)pubmed.ncbi.nlm.nih.gov
[EVALUATION OF THE EFFICASY OF THE DRUG OPDIVO (NIVOLUMAB) IN A PATIENT DIAGNOSED WITH UNRESECTABLE SKIN MELANOMA, POSITIVE BRAF MUTATION AND DISEASE DISSEMINATION (CASE REPORT)]. [2021]
Pembrolizumab and nivolumab: PD-1 inhibitors for advanced melanoma. [2022]
Soluble CD73 as biomarker in patients with metastatic melanoma patients treated with nivolumab. [2018]
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. [2022]
FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. [2018]
Nivolumab Plus Relatlimab Is Safe and Efficacious in Pretreated Melanoma. [2023]
Retrospective Side Effect Profiling of the Metastatic Melanoma Combination Therapy Ipilimumab-Nivolumab Using Adverse Event Data. [2022]
Public Adverse Event Data Insights into the Safety of Pembrolizumab in Melanoma Patients. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab. [2023]
Nivolumab: a review of its use in patients with malignant melanoma. [2021]
Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Nivolumab and pembrolizumab: Monoclonal antibodies against programmed cell death-1 (PD-1) that are interchangeable. [2022]
Nivolumab for Metastatic Melanoma. [2018]