Status:
COMPLETED
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Copenhagen University Hospital at Herlev
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
In this randomized controlled phase III study the investigators will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result i...
Detailed Description
In this randomized controlled phase III study the investigators will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result i...
Eligibility Criteria
Inclusion
- Histologically confirmed unresectable AJCC stage III or stage IV melanoma
- Patients must have metastatic melanoma with a resectable metastatic lesion(s) of sufficient size (≥ 2-3 cm in total) and must be willing to undergo such a resection for experimental purposes.
- Patients should have received maximum one line of systemic therapy (except for ipilimumab) for unresectable or metastatic melanoma.\[
- Patients must be ≥ 18 years and ≤ 75 years of age and must have measurable disease by CT or MRI per RECIST 1.1 criteria (in addition to the resected lesion).
- Patients must have a clinical performance status of ECOG 0 or 1.
- Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regimen.
- Patients must be able to understand and sign the Informed Consent document.
Exclusion
- Life expectancy of less than three months.
- Patients with metastatic ocular/ mucosal or other non-cutaneous melanoma.
- Adjuvant treatment with ipilimumab within 6 months prior to randomization.
- Requirement for immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to randomization.
- Patients who have a more than two CNS metastases.
- Patients who have any CNS lesion that is symptomatic, greater than 1 cm in diameter or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clinical or radiologic CNS progression for at least 2 months.
- All patients' toxicities due to prior non-systemic treatment must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or focal palliative radiotherapy (to non-target lesions) within the past 4 weeks, as long as all toxicities have recovered to grade 1 or less.
- Women who are pregnant or breastfeeding, because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Any active systemic infections, coagulation disorders or other active major medical illnesses.
- Any autoimmune disease
Key Trial Info
Start Date :
September 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT02278887
Start Date
September 23 2014
End Date
December 31 2023
Last Update
March 10 2025
Active Locations (2)
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1
CCIT Department of Oncology and Haematology Herlev Hospital
Copenhagen, Denmark
2
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066CX