NIVOLUMAB for Malignant melanoma (in-transit metastases)

Inclusion criteria

• {"criterion_text":"- Male or female aged above 18 years."}
• {"criterion_text":"- Signed and dated written informed consent before the start of specific protocol procedures"}
• {"criterion_text":"- 3.\tHistologically or cytologically proven in-transit metastases of malignant melanoma with or without regional lymph node metastases (AJCC v8 stage N1c, N2c and N3c)"}
• {"criterion_text":"- 4.\tMeasurable disease with at least 1 metastasis measuring at least 5 mm"}
• {"criterion_text":"- ECOG performance status of 0-2"}

Exclusion criteria

• {"criterion_text":"- Life expectancy of less than 6 months"}
• {"criterion_text":"- Active autoimmune disease. Subjects are permitted to enrolment if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger"}
• {"criterion_text":"- Has evidence of interstitial lung disease or active, non-infectious pneumonitis"}
• {"criterion_text":"- A condition requiring systemic treatment with either corticosteroids (> 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."}
• {"criterion_text":"- Has an active infection requiring systemic therapy"}
• {"criterion_text":"- Has received a live vaccine within 30 days prior to the first dose of trial treatment and 3 months after treatment"}
• {"criterion_text":"- 15.\tConcomitant therapy with any of the following: IL 2 or other non-study immunotherapy regimens; cytotoxic chemotherapy except melphalan (ILP); other investigational therapies within 30 days before trial treatment and 3 months after trial treatment."}
• {"criterion_text":"- Inability to understand given information or undergo study procedures according to protocol."}
• {"criterion_text":"- Pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within 24 hours before the administration of study drug."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes general anaesthesia."}
• {"criterion_text":"- History or evidence of clinically significant pulmonary disease e.g., severe COPD that precludes general anesthesia."}
• {"criterion_text":"- Reduced renal function defined as S-Creatinine >=1.5xULN."}
• {"criterion_text":"- Reduced hepatic function (defined as ASAT, ALAT, bilirubin >1.5 ULN and PK-INR >1.5) or a medical history of liver cirrhosis or portal hypertension"}
• {"criterion_text":"- Reduced blood leukocytes or platelets defined as a leucocyte count < 2.0x109/L and thrombocyte count <100x109/L"}

Primary endpoints

• {"endpoint_text":"- CR rate at 3 months after ILP measured according to RECIST 1.1 criteria.","definition_or_measurement_approach":"Measured according to RECIST 1.1 criteria at 3 months after ILP."}

Secondary endpoints

• {"endpoint_text":"- Time to local progression (TTLP)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Distant metastases-free survival (DMFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Melanoma-specific survival (MSS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Adverse Events (AE) and Serious Adverse Events (SAE)","definition_or_measurement_approach":"Standard AE and SAE reporting (not further specified in CTIS record)."}
• {"endpoint_text":"- QoL (FACT-M and EQ-5D)","definition_or_measurement_approach":"Quality of life measured using FACT-M and EQ-5D instruments."}
• {"endpoint_text":"- The quantitative and qualitative effects of ILP vs. ILP + nivolumab on immune cell phenotypes and function","definition_or_measurement_approach":""}

Other endpoints

• {"endpoint_text":"- Exploratory objective: To assess changes in immunological parameters during the treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Exploratory objective: To assess biomarkers for response in tumours and blood","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

01-02-2024

Latest Decision Or Authorization Date

04-02-2025

Processing Time Days

369

Number Of Sites

1

Number Of Participants

37

Netherlands

Earliest CTIS Part Ii Submission Date

01-02-2024

Latest Decision Or Authorization Date

23-04-2025

Processing Time Days

447

Number Of Sites

2

Number Of Participants

37

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden