Malignant melanoma MedDRA version: 21.1 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo (nivolumab)
Product Name: Opdivo (nivolumab)
Product Code: L01XC
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
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 metastases measuring at least 5mm 5. ECOG performance status of 0-2 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
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 before the administration of study drug. 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 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 |
|---|---|
| Main Objective: To evaluate if melphalan based isolated limb perfusion (ILP) synergizes with nivolumab in inducing complete responses (CR) in melanoma patients with in-transit metastasis. ;Secondary Objective: • To evaluate local progression-free survival (LPFS) • To evaluate overall survival (OS) • To evaluate melanoma-specific survival (MSS) • To evaluate QoL • To evaluate serious adverse events • To evaluate adverse events • To assess changes in immunological parameters during the treatment • To assess biomarkers for response in tumours and blood;Primary end point(s): CR rate at 3 months after ILP measured according to RECIST 1.1 criteria. ;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Local progression-free survival (LPFS) • Overall survival (OS) • Melanoma-specific survival (MSS) • Adverse events (AE) and Serious adverse events (SAE) • QoL (FACT-M and EQ-5D) • The quantitative and qualitative effects of ILP vs. ILP + nivolumab on immune cell phenotypes and function;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Sweden
Contacts
Public ContactRoger Olofsson Bagge
Sahlgrenska University Hospital
Outcome results
None listed