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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic diagnosis of melanoma
Greater than 3 mm
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up12 weeks after start of therapy
Awards & highlights
No Placebo-Only Group
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.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You can join this study if you have either recently been diagnosed with melanoma that has spread to nearby lymph nodes or other areas of the body, or if you have had a previous diagnosis of melanoma and it has come back in lymph nodes or other areas.
Select...
You are able to receive treatment through electroporation.
Select...
If you have cancer that has spread to the skin, soft tissues, or lymph nodes, you may still be eligible if the doctors believe it can be removed with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after start of therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after start of therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological Complete Response
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Objective Response Rate
Overall Survival
+2 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
10%
Alopecia
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
9%
Abdominal pain upper
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Atrial fibrillation
2%
General physical health deterioration
2%
Embolism
2%
Cardiac failure
2%
Adrenal insufficiency
2%
Sepsis
2%
Malignant pleural effusion
1%
Pancytopenia
1%
Atrial flutter
1%
Circulatory collapse
1%
Lung cancer metastatic
1%
Cancer pain
1%
Syncope
1%
Pericardial effusion
1%
Colitis
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal haemorrhage
1%
Small intestinal obstruction
1%
Performance status decreased
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Confusional state
1%
Bronchial obstruction
1%
Pneumothorax
1%
Respiratory tract infection
1%
Respiratory failure
1%
Superior vena cava syndrome
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4120
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
527 Previous Clinical Trials
134,018 Total Patients Enrolled
42 Trials studying Melanoma
3,194 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a previous diagnosis of a lung disease called interstitial lung disease.Your organs are not functioning well enough according to the study's guidelines.You can join this study if you have either recently been diagnosed with melanoma that has spread to nearby lymph nodes or other areas of the body, or if you have had a previous diagnosis of melanoma and it has come back in lymph nodes or other areas.You are able to receive treatment through electroporation.You have a very strong allergic reaction (Grade 3 or higher) to nivolumab or any of its ingredients.You have a history of lung inflammation (not caused by an infection) that required treatment with steroids, or you currently have lung inflammation.You have already received a type of immunotherapy called anti-PD1 or anti-PDL1.If you have cancer that has spread to the skin, soft tissues, or lymph nodes, you may still be eligible if the doctors believe it can be removed with surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elucidate on the academic research that has utilized Nivolumab?
"Presently, there are 82 Phase 3 trials for Nivolumab with 718 studies in total. The majority of these investigations take place in Basel, BE; however, globally 40237 sites are executing rigorous clinical research on this drug."
Answered by AI
Is this a pioneering clinical trial?
"According to current records, there are 718 Nivolumab studies taking place in 49 countries and 2354 cities. The initial trial for the drug began back in 2012 and was sponsored by Ono Pharmaceutical Co. Ltd. It had 659 participants who completed its Phase 1 & 2 testing stages successfully; since then 252 further investigations have been carried out."
Answered by AI
To what maladies is Nivolumab typically prescribed?
"Nivolumab can be employed to treat malignant neoplasms, intractable melanoma and squamous cell carcinomae melanoma and squamous cell carcinoma."
Answered by AI
To what extent has enrollment been achieved in this clinical research?
"Indeed, the clinicaltrials.gov page lists this medical trial as actively recruiting participants since its initial post on December 22nd 2020 and last update in November 2022. To date, 33 individuals have been invited to join from a single location."
Answered by AI
Is this research effort still seeking participants?
"Clinicaltrials.gov confirms that this research is presently seeking participants, having been first posted on December 22nd 2020 and edited as recently as November 3rd 2022."
Answered by AI
Has Nivolumab been authorized by the Food and Drug Administration?
"Due to the Phase 2 nature of this trial, there is some evidence that Nivolumab is safe. Thus, our team assigned it a score of 2 out of 3 on Power's scale."
Answered by AI
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