Randomized non-comparative phase II trial of nivolumab plus paclitaxel in subjects with recurrent/metastatic head and neck squamous cell carcinoma unable for cisplatin-based chemotherapy. NIVOTAX TTCC study.
Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who are ineligible for cisplatin have limited treatment options, and the role of chemoimmunotherapy in this population remains unexplored. NIVOTAX was a randomized, non-comparative, multicenter, phase II trial ev...
| Published in: | European Journal of Cancer Vol. 241 |
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| Main Authors: | , , , , , , , , , , , , , , , , , , , |
| Format: | research randomized controlled trial Journal Article |
| Published: |
Pergamon Press - An Imprint of Elsevier Science
Jun2026
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=194226031&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 194226031 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09598049 1VW jtl: European Journal of Cancer issn: 09598049 maglogo: N pubinfo: dt: Jun2026 vid: 241 pid: 2410 pub: Pergamon Press - An Imprint of Elsevier Science artinfo: ui: 194226031 194226031 194226031 10.1016/j.ejca.2026.116775 194226031 ppct: 1 formats: tig: atl: Randomized non-comparative phase II trial of nivolumab plus paclitaxel in subjects with recurrent/metastatic head and neck squamous cell carcinoma unable for cisplatin-based chemotherapy. NIVOTAX TTCC study. aug: au: Docampo, Lara Iglesias Basté, Neus Oliva, Marc Carral, Alberto Pérez Segura, Pedro Medina-Colmenero, Ana Cirauqui, Beatriz Arrazubi, Virginia Martínez Trufero, Javier Gutiérrez Calderón, Vanesa García Castaño, Almudena Rubió-Casadevall, Jordi del Barco, Edel Basterretxea, Laura Bruixola, Gema Cabellos, Ruth Álvarez Flor, María José Braña, Irene Caballero, Javier Martínez, Joaquina affil: Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain sug: subj: Head and Neck Neoplasms Drug Therapy Carcinoma, Squamous Cell Drug Therapy Neoplasm Recurrence, Local Neoplasm Metastasis Immune Checkpoint Inhibitors Therapeutic Use Antineoplastic Agents Therapeutic Use Paclitaxel Therapeutic Use Drug Therapy, Combination Drug Resistance, Neoplasm Treatment Failure Cisplatin Chemotherapy, Cancer Treatment Outcomes Evaluation Human Randomized Controlled Trials Random Assignment Antineoplastic Agents Administration and Dosage Progression-Free Survival Overall Survival Patient Safety Prospective Studies Confidence Intervals Descriptive Statistics Adverse Drug Event Mortality ab: Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who are ineligible for cisplatin have limited treatment options, and the role of chemoimmunotherapy in this population remains unexplored. NIVOTAX was a randomized, non-comparative, multicenter, phase II trial evaluating paclitaxel plus nivolumab (nivotax) in previously untreated, platinum-ineligible R/M HNSCC (platinum-refractory, unfit, or cumulative dose ≥225 mg/m²). Patients were randomized 2:1 to weekly paclitaxel (80 mg/m²) plus biweekly nivolumab (240 mg) or weekly cetuximab (250 mg/m²) for 12 weeks, followed by maintenance nivolumab q4 weeks or weekly cetuximab for up to 24 months. The primary endpoint was 2-year overall survival (2yOS). Key secondary endpoints were median OS; progression-free survival (PFS), overall response rate (ORR) and safety. 141 patients were randomized (nivotax, n = 93; Erbitax, n = 48). Baseline characteristics were balanced. After a median follow-up of 12.1 months (33.1 months for alive patients), 2yOS was 24.7% (95% CI 15.9–33.5) with nivotax and 13.4% (95% CI 3.6–23.2) with Erbitax. Median OS, PFS and ORR were similar in both arms. No differences were observed by age, PD-L1 CPS and Karnofsky Performance Scale. Grade > 3 treatment-related adverse events (AEs) occurred in 38% and 43% of patients, respectively. Higher mortality was observed in the nivotax arm (18% vs 8.3%) due to higher occurrence of respiratory AEs deemed treatment unrelated by investigators. The primary endpoint of 2yOS was met. However, respiratory AEs and associated mortality emerged as a safety concern in the nivotax arm, limiting further evaluation of this regimen. • The NIVOTAX trial met its primary endpoint of improved 2-year OS rate. • PFS, ORR and DCR were similar in nivotax and erbitax regimens. • Age, KPI and PDL1 CPS status did not impact on efficacy parameters. • Safety profile was similar in both treatment regimens. • Increased treatment unrelated respiratory events led to higher mortality in the nivotax arm. pubtype: Academic Journal doctype: research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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