study comparing til to standard ipilimumab in patients with metastatic melanoma

Conditions: Metastatic Melanoma

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 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.

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. this will be done via questionnaires at baseline, just after treatment and during follow-up. also healthcare providers will be interviewed after 6 months after starting the trial.

Eligibility criteria:
inclusion criteria: * 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 criteria: * 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

Keywords: melanoma til treatment tumor infiltrating lymphocytes ipilimumab interleukin 2 non-myeloablative randomization