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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 at least four weeks after the last dose of nivolumab at end of study (eos) visit
Awards & highlights
No Placebo-Only Group
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.
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.
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 ~ at least four weeks after the last dose of nivolumab at end of study (eos) visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least four weeks after the last dose of nivolumab at end of study (eos) visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pathologic Complete Response
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Objective Response Rate
Overall Survival
+2 moreSide effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
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
2015
Completed Phase 3
~4010
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,831 Total Patients Enrolled
43 Trials studying Melanoma
3,277 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
221 Total Patients Enrolled
4 Trials studying Melanoma
151 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.
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