malignant melanoma skin cancer
Conditions
Interventions
Eligible patients (n=168) will be randomized between arm A and B. Patients that
are randomized in arm A will receive standard therapy with ipilimumab , 3
mg/kg, q 3 weeks, maximal 4 times. Patients
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically confirmed unresectable AJCC stage IIIc 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 no previous systemic therapy for unresectable or metastatic melanoma or one line of any kind of systemic treatment, except for ipilimumab. • Patients must be >= 18 years and
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (according to RECIST 1.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS at 6 months (according to RECIST 1.1) and PFS according to irRC. Overall response rate (RECIST 1.1 and immune related response criteria (irRC)), complete response rate, overall survival and safety. | — |
Countries
Netherlands
Outcome results
None listed