Study Summary
This trial is testing a new treatment for melanoma that involves a combination of two drugs. The study is open to people with operable melanoma who have not yet received treatment.
Treatment Effectiveness
Study Objectives
1 Primary · 5 Secondary · Reporting Duration: 12 weeks after start of therapy
Week 12
Objective Response Rate
Relapse Free Survival
Week 16
Pathological Complete Response
Week 16
Risk of Surgical Delay
Year 5
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Overall Survival
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
Trial Design
1 Treatment Group
Neoadjuvant Treatment
1 of 1
Experimental Treatment
33 Total Participants · 1 Treatment Group
Primary Treatment: Nivolumab · No Placebo Group · Phase 2
Neoadjuvant TreatmentExperimental Group · 3 Interventions: OncoSec Medical Electroporation Therapy System, Nivolumab, Tavo · Intervention Types: Device, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after start of therapy
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
504 Previous Clinical Trials
125,980 Total Patients Enrolled
41 Trials studying Melanoma
3,365 Patients Enrolled for Melanoma
OncoSec Medical IncorporatedIndustry Sponsor
10 Previous Clinical Trials
344 Total Patients Enrolled
3 Trials studying Melanoma
218 Patients Enrolled for Melanoma
Ahmad Tarhini, MD, PhDPrincipal InvestigatorMoffitt Cancer Center
5 Previous Clinical Trials
131 Total Patients Enrolled
3 Trials studying Melanoma
61 Patients Enrolled for Melanoma
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis.
You have primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis.
You have a clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis.
You have a primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis.
Participants with in transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist.
References
- Jacobs, Liesl, Lidia Yshii, Steffie Junius, Nick Geukens, Adrian Liston, Kevin Hollevoet, and Paul Declerck. 2021. “Intratumoral Dna-based Delivery of Checkpoint-inhibiting Antibodies and Interleukin 12 Triggers T Cell Infiltration and Anti-tumor Response”. Cancer Gene Therapy. Springer Science and Business Media LLC. doi:10.1038/s41417-021-00403-8.
- 2020. "Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04526730.
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