malignant melanoma skincancer
Conditions
Interventions
Arm A: ILP + Nivolumab 480mgx1
Arm B: ILP + Placebo x1
Sponsors
Sahlgrenska University Hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged above 18 years. 2. Signed and dated written informed consent before the start of specific protocol procedures. 3. Histologically or cytologically proven in-transit metastases of malignant melanoma with or without regional lymph node metastases (AJCC v8 stage N1c, N2c and N3c). 4. Measurable disease with at least 1 metastasis measuring at least 5 mm 5. ECOG performance status of 0-2
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 6 months 2. Inability to understand given information or undergo study procedures according to protocol 3. Pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within 24 hours to the start of study. 4. Patients must agree to follow instructions for method of contraception for 5 months (women) and 7 months (males) after treatment, described in section 8.4. 5. History of ischemic cardiac disease or history of congestive heart failure with an LVEF =1.5xULN or Creatinine Clearance 1.5 ULN and PK-INR>1.5) or a medical history of liver cirrhosis or portal hypertension 9. Reduced blood leukocytes or platelets defined as a leucocyte count 10 mg daily prednisone equivalents) or other immunosuppressive medications within 30 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 13. Has an active infection requiring systemic therapy. 14. Has received a live vaccine within 30 days prior to the first dose of trial treatment and 3 months after treatment. 15. Concomitant therapy with any of the following: IL 2 or other non-study immunotherapy regimens; cytotoxic chemotherapy except melphalan (ILP); other investigational therapies 30 days before and after treatment in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To evaluate if isolated limb perfusion (ILP) synergizes with nivolumab in inducing complete responses (CR) in melanoma patients with in-transit metastasis, compared to isolated limb perfusion with placebo: CR rate at 6 months after ILP measured according to RECIST 1.1 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate local progression-free survival (LPFS) - To evaluate overall survival (OS) - To evaluate melanoma-specific survival (MSS) - To evaluate the Adverse events (AE) and Serious adverse events (SAE) - To evaluate QoL (FACT-M and EQ-5D) - To evaluate the quantitative and qualitative effects of ILP vs. ILP + nivolumab on immune cell phenotypes and function Exploratory objectives: - To assess changes in immunological parameters during the treatment - To assess biomarkers for response in tumours and blood | — |
Countries
Netherlands
Outcome results
None listed