Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck

Summary

INDICATION: Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy.

Timeline

Start

2017-03-24

Primary completion

2019-01-01

Completion

2021-10-20

Outcome

Mixed primary results

paper In the ACC cohort, with 15/45 patients non-progressive at 6 months, the primary endpoint was met (33.3%; 95% CI 21.8 to NE). PMID 39886516 ↗

paper Nivolumab failed to demonstrate efficacy in the non-ACC cohort (NPR6m: 14.0%; 7/50 patients). PMID 39886516 ↗

Publications

• Fayette J, Even C, Digue L, Geoffrois L, Rolland F, Cupissol D, Guigay J, Le Tourneau C, Dillies AF, Zanetta S, Bozec L, Borel C, Couchon-Thaunat S, Costes-Martineau V, Sudaka-Bahadoran A, Jallut I, Garic F, Lardy-Cleaud A, Chabaud S. NISCAHN: a phase II trial of nivolumab in patients with salivary gland carcinoma (Unicancer ORL-08). BMJ Oncol. 2023 Oct 30;2(1):e000065. doi: 10.1136/bmjonc-2023-000065. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous

Indications