← Back to Search

Adoptive Cell Therapy

Immunotherapy + Adoptive Cell Therapy for Melanoma

N/A
Waitlist Available
Led By Amod Sarnaik, M.D.
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
No evidence of ongoing cardiac dysrhythmia ≥ grade 2 (NCI Common Terminology Criteria for Adverse Events [CTCAE], v4.0)
Adequate renal, hepatic and hematologic function, including specific criteria for creatinine, total bilirubin, AST, ALT, hemoglobin, WBC, granulocytes, and platelets
Must not have
History of autoimmune disease that require immunosuppressive medications at the time of screening
Unable to comprehend and give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and benefits of using a patient's own immune cells to fight cancer, in combination with a drug that boosts the immune system.

Who is the study for?
This trial is for adults with stage III or IV melanoma that hasn't spread to more than three areas in the brain. They can't have had ipilimumab before but may have had other treatments. Participants need good organ function and performance status, not be pregnant, agree to use contraception, and cannot have certain medical conditions or a history of severe autoimmune disease.
What is being tested?
The study tests combining TIL (a type of white blood cell) therapy with ipilimumab (an immunotherapy drug), along with lymphodepletion (lowering white blood cells), high dose IL-2 (a substance that activates immune cells), and adoptive cell transfer to see if this approach is safe and effective against melanoma.
What are the potential side effects?
Possible side effects include reactions from the immune system such as inflammation in different body parts, fatigue, allergic responses, changes in blood counts leading to increased infection risk or bleeding problems. The treatment might also affect normal organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have serious heart rhythm problems.
Select...
My kidney, liver, and blood tests are within normal ranges.
Select...
I can do all or most of my usual activities.
Select...
I tested positive for Epstein-Barr virus antibodies.
Select...
I still have visible cancer after surgery aimed at growing immune cells.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking immunosuppressive drugs for an autoimmune disease.
Select...
I am unable to understand and agree to the study's details.
Select...
I agree to use two approved birth control methods during and 6 months after treatment.
Select...
I have been treated with ipilimumab before.
Select...
I have up to 3 untreated brain tumors, with at least one larger than 1 cm or causing swelling.
Select...
I am not on long-term steroids for immune suppression.
Select...
I have more than 3 untreated brain metastases or swelling around the tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Occurrence of Dose Limiting Toxicity (DLT) Events
Rate of Meeting Feasibility Requirements
Secondary study objectives
Overall Response Rate (ORR)
Progression Free Survival (PFS)

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
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: Combination TherapyExperimental Treatment7 Interventions
The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2015
Completed Phase 3
~3070

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Industry Sponsor
24 Previous Clinical Trials
1,834 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,835 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,534 Total Patients Enrolled

Media Library

Adoptive Cell Therapy with TIL (Adoptive Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01701674 — N/A
Skin Cancer Research Study Groups: Combination Therapy
Skin Cancer Clinical Trial 2023: Adoptive Cell Therapy with TIL Highlights & Side Effects. Trial Name: NCT01701674 — N/A
Adoptive Cell Therapy with TIL (Adoptive Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01701674 — N/A
~1 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top