NCT02278887CompletedPhase 3
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma
Randomized Phase III Study Comparing a Non-myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Tumor Infiltrating Lymphocytes and Interleukin-2 to Standard Ipilimumab Treatment in Metastatic Melanoma
Source: ClinicalTrials.gov · Last updated 10 Mar 2025
Brief summary (registry, in English)
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 in an improved progression free survival when randomly compared to ipilimumab in 168 stage IV melanoma patients. A health technology assessment (HTA) will be performed to evaluate the impact of the TIL treatment on patients and organizational processes and cost-effectivity.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 168 (actual)
- First submitted
- 3 Jun 2014
- Start date
- 23 Sept 2014
- Primary completion date
- Sept 2022
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Melanoma
- NCT number
- NCT02278887
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 168
- From 23 Sept 2014 to the primary completion date, Sept 2022
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Any active systemic infections, coagulation disorders or other active major medical illnesses.
- Any autoimmune disease
Other
- Life expectancy of less than three months.
- Patients with metastatic ocular/ mucosal or other non-cutaneous melanoma.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CCIT Department of Oncology and Haematology Herlev Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.