Metastatic malignant melanoma MedDRA version: 17.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Tumor Infiltrating Lymphocytes
Product Code: TIL
Pharmaceutical Form: Infusion
INN or Proposed INN: TIL2014-001419-38
Othe
Sponsors
Center for Cancer Immune Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed metastatic or locally advanced malignant melanoma - Histopathologically confirmed BRAF mutation - Patients must have a resectable lesion - Patients must be between 18 years and 70 years of age and must have measurable disease - Patients must have a clinical performance status of ECOG 0 or 1. - Adequate organ function - Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for six months after receiving the preparative regimen. - Patients must be able to understand and sign the Informed Consent document. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: - Patients with other cancers within 5 years - Patients with ocular melanoma - Former treatment with BRAF inhibitor - Serious comorbity or autoimmune disease - Requirement for immunosuppressive doses of systemic corticosteroids or other immunosuppressive drugs - Patients who have any CNS lesion that is symptomatic 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 1 month. - Other anticancer treatment within 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate toxicity (according to CTCAE version 4.0) and feaseability.; Secondary Objective: To evaluate treatment related immune responses To evaluate clinical response (according to RECIST 1.1 - response rate, progressionfri survival and overall survival) ;Primary end point(s): The primary endpoint is toxicity (according to CTCAE 4.0).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated before treatment, during treatment and at follow-up visits untill 6 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are treatment related immune response and clinical response (according to RECIST 1.1 - response rate, progressionfree survival and overall survival).;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated after all patients have received treatment and clinical response is evaluated. Estimated 1 year after treatment of last patient. | — |
Countries
Denmark
Contacts
Public ContactCenter for Cancer Immune Therapy
Center for Cancer Immune Therapy
Outcome results
None listed