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Bending the Curve Trial by Trial
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OpACIN

Needs review

Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma

N = 20

Population
Patients with palpable stage III melanoma
Design
Small randomised study (1:1) testing feasibility: ipilimumab 3 mg/kg plus nivolumab 1 mg/kg as four courses after surgery (adjuvant arm) or two courses before and two after surgery (neoadjuvant arm).
Arms
  • Adjuvant arm (control, n = 10): Four courses of ipilimumab 3 mg/kg plus nivolumab 1 mg/kg after surgery
  • Neoadjuvant arm (experimental, n = 10): Two courses of ipilimumab 3 mg/kg plus nivolumab 1 mg/kg before surgery and two courses after
People
Blank CU, senior author Schumacher TN
Show the numbers
Results reported for OpACIN
EndpointAnalysisNeoadjuvant armAdjuvant armEffect
Pathological response rateNeoadjuvant arm, patients evaluable for pathological response (7 of 9)exploratoryBlank 201878%—Seven of nine patients (78%) in the neoadjuvant arm had a pathological response; none of these had relapsed at a median follow-up of 25.6 months. Nine of 10 patients in each arm had one or more grade 3 or 4 adverse events. All neoadjuvant patients underwent surgery at the preplanned time point.
Results reported for OpACIN
EndpointAnalysisNeoadjuvant armAdjuvant armEffect
Pathological response rateNeoadjuvant arm, patients evaluable for pathological response (7 of 9)exploratoryBlank 201878%—Seven of nine patients (78%) in the neoadjuvant arm had a pathological response; none of these had relapsed at a median follow-up of 25.6 months. Nine of 10 patients in each arm had one or more grade 3 or 4 adverse events. All neoadjuvant patients underwent surgery at the preplanned time point.
Primary publication: Blank CU, Rozeman EA, Fanchi LF, Sikorska K, van de Wiel B, Kvistborg P, et al. Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma. Nat Med. 2018;24(11):1655-1661. PubMedDOI

Appears in

Sources

  1. Blank CU, Rozeman EA, Fanchi LF, Sikorska K, van de Wiel B, Kvistborg P, et al. Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma. Nat Med. 2018;24(11):1655-1661.

    PubMedDOI