Nivolumab

Opdivo®

IgG4 antibody, binds to the PD1 receptor on T cells and inhibits interaction with the ligands PD-L1 and PD-L2 on cancer cells.

04/2016 (unresectable, metastatic melanoma), 08/2018 (adjuvant).

As monotherapy or in combination with ipilimumab for advanced, unresectable or metastatic melanoma.

As monotherapy for the adjuvant treatment of stage IIIB, IIIC or IV melanoma after complete resection.

Differential blood count, blood chemistry panel (Na, K, 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, hs-troponin T, troponin I, NT-proBNP, S-100, pregnancy test, ECG, echocardiography (in patients with cardiovascular risk).

Before each administration: differential blood count, chemogram (Na, K, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, ASAT, ALAT, gammaGT, alk. phosphatase, LDH, pancreatic amylase, total protein, CRP, CK), glucose; every 2 months: TSH, fT4.

i.v. infusion over 30 min. Combination therapy: 1 mg/kg nivolumab followed by ipilimumab 3 mg/kg over 90 min. A total of 4 cycles every 3 weeks, then monotherapy with 240 mg every 2 weeks starting 3 weeks after the last dose of the combination. Monotherapy: 240 mg every 2 weeks (additional FDA and EMA approval: 480 mg every 4 weeks over 60 min.)

Until disease progression or the occurrence of unacceptable toxicity; adjuvant for a maximum of 12 months or until recurrence.

See the specialist literature or guidelines and study results.

Women: negative pregnancy test, double contraception until 120 days after the last infusion, offer reproductive counselling.

Men: adequate contraception until 120 days after the last infusion, offer reproductive counselling.

No live vaccines for 30 days before starting therapy and during treatment.