RecruitingPhase 2NCT03166397

Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients

A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients

Sponsor

Sheba Medical Center

Enrollment

30 participants

Start Date

Jun 5, 2017

Study Type

INTERVENTIONAL

Conditions

Malignant Melanoma Stage IV

Summary

Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective response rates of approximately 50 percent in patients with highly advanced, refractory metastatic melanoma. Recent developments in theTIL ACT procedure facilitate the use of a reduced-intensity, non-myeloablative, lympho-depleting preparative regimen which is expected to be both less toxic and equally efficient compared to previous regimens. Recently patients recruited post Anti PD-1 therapy had inferior responses in comparison to the pre immune checkpoint inhibitors era. Therefore 2 new arms were added: 1. TIL-ACT with combination of 2 doses of Nivolumab fixed dose 480mg, pre and post TIL. 2. TIL-ACT with FMT given using colonoscopy once and 2 maintenance doses of 12 orally ingested capsules, concurrently with a single dose of Ipilimumab 1 mg/kg up to 100 mg.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment where immune cells (called TILs — tumor-infiltrating lymphocytes) are taken from a patient's own tumor, grown in large numbers in a lab, and then infused back into the patient to fight advanced melanoma (a serious type of skin cancer) that has spread. **You may be eligible if...** - You are 18 years or older - You have melanoma that has spread and has not responded to standard treatments - You have at least one tumor that can be surgically removed to collect immune cells - You are in good physical health (able to carry out most daily activities) - You are willing to use birth control during and for 120 days after treatment - Any brain tumors are small and stable **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active, uncontrolled infections - You have serious organ problems (heart, lungs, liver, kidneys) - You have certain autoimmune diseases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.

DRUGCyclophosphamide

Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.

BIOLOGICALTIL

TIL administration

DRUGIL-2

Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.

DRUGNivolumab

Nivolumab 480 mg fixed dose

DRUGIpilimumab

Ipilimumab 1 mg/kg up to 100 mg

DRUGFMT Protocol

FMT given both directly into the colon via colonoscopy and orally using capsules (12 capsules each time). FMT will be taken from melanoma patients treated with Anti PD-1 who achieved a durable response of more than 12 months.

Locations(1)

Sheba Medical Center

Ramat Gan, Israel

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