Nov 2023: Nivolumab (Opdivo, Bristol-Myers Squibb Company) was granted approval by the Food and Drug Administration as an adjuvant therapy for Stage IIB/C melanoma in patients 12 years of age and older who had undergone complete resection.
In the randomized, double-blind trial CHECKMATE-76K (NCT04099251), which included 790 patients with Stage IIB/C melanoma, efficacy was assessed. A placebo or 480 mg nivolumab was administered intravenously to patients in a randomized (2:1) fashion every four weeks for a maximum of one year, or until disease recurrence or unacceptable toxicity occurred.
A complete resection of the primary melanom with negative margins and a negative sentinel lymph node within 12 weeks prior to randomization, as well as an ECOG performance status of 0 or 1, were prerequisites for enrollment. Patients who met the inclusion criteria for the trial did not have ocular/uveal or mucosal melanoma, autoimmune disease, any condition necessitating systemic treatment with corticosteroids (equivalent to or exceeding 10 mg of daily prednisone) or other immunosuppressive drugs, or prior melanoma therapy other than surgery. AJCC 8th staging system edition stratification of randomization was employed (T3b versus T4a versus T4b).
Det primære effektmålet var residivfri overlevelse (RFS), som etterforskerne definerte som tiden mellom randomisering og den tidligste av følgende hendelser – tilbakefall av lokal, regional eller fjern metastase, nytt primært melanom eller dødelighet (uavhengig av årsak). ). Evalueringer ble utført med 26 ukers intervaller fra år ett til tre, og deretter hver 52. uke i de følgende fem årene. I både nivolumab- og placebo-armene ble ikke median RFS oppnådd (95 % KI: 28.5, ikke nådd; p-verdi <0.0001). Fareforholdet var 0.42 [95 % KI: 0.30, 0.59]; p-verdien var mindre enn 0.0001.
Mood swings, musculoskeletal pain, pruritis, rash, and diarrhea were the most frequently reported adverse effects (>20% of patients).
Patients weighing 40 kg or more are advised to take 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks until disease progression or unacceptable toxicity, for a maximum of one year. For up to one year, pediatric patients weighing less than 40 kg are prescribed a dosage of 3 mg/kg every two weeks or 6 mg/kg every four weeks, until disease progression or unacceptable toxicity occurs.
