Nivolumab + Relatlimab

Opdualag®

Nivolumab: Inhibits interaction with PD-L1 and PD-L2 ligands on cancer cells

Relatlimab: Binds to LAG-3 receptor and thereby cancelling the inhibition of the immune response mediated by LAG-3 by blocking its interaction with ligands.

12/2022

Non-resectable or metastatic melanoma with PD-L1 expression < 1%

Differential blood count, biochemical panel (sodium, potassium, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, ASAT, ALAT, gamma-GT, alkaline phosphatase, LDH, pancreatic amylase, total protein, CRP, CK), glucose, cortisol, TSH, fT4, high-sensitivity troponin T, troponin I, NT-pro BNP, S-100, pregnancy test, viral serologies if necessary (hepatitis B/C, HIV, CMV, EBV) ECG, echocardiography (if cardiovascular risk is present)

Before each administration: differential blood count, biochemical panel (sodium, potassium, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, ASAT, ALAT, gamma-GT, alkaline phosphatase, LDH, pancreatic amylase, total protein, CRP, CK), glucose; every 2 months: TSH, fT4

(If necessary, initial weekly monitoring of the differential blood count and biochemical panel)

Administered every 4 weeks as an intravenous infusion over 30 minutes

Treatment should be continued as long as a clinical benefit is observed or until the treatment is no longer tolerated by the patient.

Refer to the relevant medical literature, guidelines, and clinical studies.

• Women: negative pregnancy test, dual contraception up to 5 months after the last infusion
• No live vaccines 30 days before the start of and during therapy