OncoMatch/Clinical Trials/NCT03685890
Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion
Is NCT03685890 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Nivolumab for melanoma.
Treatment: Nivolumab — To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms. In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3 months. An independent data safety monitoring board (DSMB) will continuously review safety and judge the seriousness of the events and also recommend the study to stop if necessary. If the DSMB do not find safety issues, the trial will continue as a phase II trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage N1C, N2C, N3C
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: IL 2 or other non-study immunotherapy regimens
Concomitant therapy with any of the following: IL 2 or other non-study immunotherapy regimens
Cannot have received: cytotoxic chemotherapy
Exception: except melphalan (ILP)
cytotoxic chemotherapy except melphalan (ILP)
Cannot have received: other investigational therapies
other investigational therapies within 30 days before trial treatment and 3 months after trial treatment
Lab requirements
Blood counts
leucocyte count < 2.0x10^9/L and thrombocyte count <100x10^9/L
Kidney function
S-Creatinine >=1.5xULN
Liver function
ASAT, ALAT, bilirubin >1.5 ULN and PK-INR >1.5; medical history of liver cirrhosis or portal hypertension
Cardiac function
active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes general anaesthesia
Active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes general anaesthesia. Reduced renal function defined as S-Creatinine >=1.5xULN. 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. Reduced blood leukocytes or platelets defined as a leucocyte count < 2.0x10^9/L and thrombocyte count <100x10^9/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify