NIVOPOSTOP (GORTEC 2018-01): A phase III randomized trial of adjuvant nivolumab added to radio-chemotherapy in patients with resected head and neck squamous cell carcinoma at high risk of relapse
Abstract
LBA2
Background:
The standard of care (SOC) over the past two decades for resected locally advanced SCCHN (LA-SCCHN) with high-risk of relapse is adjuvant cisplatin-radiotherapy (CRT). Despite these definitive treatments, many patients develop recurrence, indicating that more effective treatments are needed. This study evaluated the addition of nivolumab (NIVO) to SOC CRT compared to SOC CRT alone after surgery.
Methods:
NIVOPOSTOP is an international randomized, open-label Phase 3 trial (NCT03576417). Main inclusion criteria were patients < 75 years, ECOG PS 0-1, with resected LA-SCCHN of the oral cavity, oropharynx (OPC), hypopharynx or larynx at high-risk of relapse defined by presence of nodal extra capsular extension and/or positive tumor margins, ≥4 nodal involvements, multiple peri-neural invasion. The primary endpoint was Disease Free Survival (DFS); key secondary endpoints include overall survival (OS) and safety. Patients were randomized 1:1 after surgery to receive Arm A SOC 66 Gy RT and cisplatin (100 mg/m2 every 3 weeks (Q3W) for three cycles) or Arm B NIVO 240 mg, followed by SOC CRT with 3 cycles of NIVO 360 mg Q3W, and followed by 6 cycles of NIVO 480 mg Q4W. Treatment allocation was done by minimization for centers and p16 status. To detect a HR of events of 0.65 at 2-sided alpha error 0.05 and power 90%, 230 events were required. Analysis was performed when this required number of events was reached (cutoff date April 30, 2024).
Results:
A total of 680…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 680 participants or records.
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