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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)
Tumor may have a B-RAF V600 mutation or be BRAF wild type, and patients must not have been previously treated with ipilimumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I do not have serious heart rhythm problems.
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My tumor may have a BRAF mutation, and I haven't been treated with ipilimumab.
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I may or may not have had treatment for my metastatic disease. If I have a V600 BRAF mutation, I might have been treated with a BRAF inhibitor.
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My kidney, liver, and blood tests are within normal ranges.
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I can do all or most of my usual activities.
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I have had surgery or radiation for brain metastases and meet specific conditions.
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I have up to 3 untreated brain metastases.
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I tested positive for Epstein-Barr virus antibodies.
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I have antibiotic allergies, but I understand the treatment minimizes exposure.
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I still have visible cancer after surgery aimed at growing immune cells.
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I have advanced melanoma that cannot be removed by surgery and am considered a good candidate for a specific immune therapy.

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

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

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Lung abscess
1%
Cerebrovascular accident
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

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
2014
Completed Phase 3
~2640

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,978 Total Patients Enrolled
43 Trials studying Melanoma
3,228 Patients Enrolled for Melanoma
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,288 Total Patients Enrolled
177 Trials studying Melanoma
57,553 Patients Enrolled for Melanoma
Iovance Biotherapeutics, Inc.Industry Sponsor
20 Previous Clinical Trials
1,683 Total Patients Enrolled
9 Trials studying Melanoma
946 Patients Enrolled for Melanoma

Media Library

Adoptive Cell Therapy with TIL (Adoptive Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01701674 — N/A
Melanoma Research Study Groups: Combination Therapy
Melanoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present population size of this clinical trial?

"At this moment, no further participants are being sought for the trial posted on October 9th 2012 and last amended on November 8th 2022. If you search other clinical trials related to metastatic melanoma there are currently 767 open studies and 1220 involving Ipilimumab recruiting patients."

Answered by AI

Are there still opportunities to participate in this experiment?

"Based on the information published on clinicaltrials.gov, this specific medical trial is no longer accepting subjects into their research program as it was last edited in November 2022. Nevertheless, there are 1987 other ongoing studies looking for participants at present time."

Answered by AI

Have researchers previously conducted research studies using Ipilimumab?

"As of now, 1220 clinical trials have been launched to investigate the usage of ipilimumab. Of these live studies, 200 are in Phase 3. While Philadelphia is a major hub for this treatment's research, there exists 49 026 trial sites across America offering it."

Answered by AI

What medical conditions is Ipilimumab typically employed to assuage?

"Ipilimumab is the preferred treatment for a variety of malignancies, particularly lung cancer. The drug has also been known to help treat multiple sclerosis, leukemia, myelocytic, acute and inoperable melanoma cases."

Answered by AI
~1 spots leftby Mar 2025