Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Immunotherapy for Melanoma
Phase 2
Waitlist Available
Led By Ahmad Tarhini, MD, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after start of therapy
Awards & highlights
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.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site due to electroporation, immune-related issues such as inflammation in organs from nivolumab, fatigue, skin problems like rash or itching, flu-like symptoms including fever and chills.
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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
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
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
~4750
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,475 Total Patients Enrolled
43 Trials studying Melanoma
3,201 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
6 Previous Clinical Trials
161 Total Patients Enrolled
4 Trials studying Melanoma
91 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I still have side effects from previous treatments that are not mild.I have had pneumonitis treated with steroids or have it now.I have not received a live-virus vaccine in the last 30 days.I have melanoma that has spread to one lymph node, and we don't know where it started.I have not been in another clinical study or had systemic therapy in the last 30 days.I have an immune system disorder or have been on steroids or other immune-weakening drugs recently.I am eligible for surgery.I have a history of lung scarring or fibrosis.I am currently being treated for an infection.I have been treated with anti-PD1 or anti-PDL1 immunotherapy before.I need some help with my daily activities.My organs are not functioning well enough for the study.I have been diagnosed with melanoma.I am a man who will not father a child or will use birth control during and for 5 months after the study.I am 18 years old or older.I haven't received blood products or specific medications to stimulate blood cell production in the last 4 weeks.I have had a full body scan and brain MRI or CT for my condition within the last 4 weeks.I have skin, soft tissue, or lymph node cancer that can be surgically removed and biopsied.I have melanoma with spread to lymph nodes or distant parts of the body, or it has come back in these areas.I have another cancer besides skin or in situ cervical cancer, but it's not active or progressing.I am not pregnant, can use birth control, and agree to do so during and after the study.My cancer has spread to nearby skin or lymph nodes but can be removed with surgery.I do not have active Hepatitis B or C, or I am vaccinated against Hepatitis B.My melanoma has spread to several nearby lymph nodes, confirmed by a doctor.
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 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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger