Phase III study of nivolumab alone or combined with ipilimumab as immunotherapy versus standard of care in resectable head and neck squamous cell carcinoma.
Henrike B ZechNikolaus MoeckelmannArne BoettcherAdrian MuenscherMascha BinderEik VettorazziCarsten BokemeyerPhilippe SchafhausenChristian S BetzChia-Jung BuschPublished in: Future oncology (London, England) (2020)
Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) often requires postoperative chemoradiation with high risk of toxicity. Disease-free survival (DFS) after 2 years is approximately 70%. Combining nivolumab (N), a PD-1-inhibitor and ipilimumab (I), a CTLA4- inhibitor, may improve DFS due to antitumor effects of immunotherapy. The IMSTAR-HN study compares neoadjuvant N and N ± I 6 months after adjuvant therapy versus standard therapy as first-line treatment for LA-HNSCC. Eligible patients have treatment-naive LA-HNSCC, Eastern cooperative oncology group performance score (PS) ≤1 and no distant metastasis. 276 patients will be randomized into two arms. Primary endpoint is DFS and secondary endpoint includes locoregional control (LRC) and overall survival (OS). This study is one of the first in HNSCCs implementing immunotherapy in first-line treatment in a curative setting. Clinical Trial Registration: NCT03700905 (ClinicalTrials.gov).
Keyphrases
- locally advanced
- phase iii
- clinical trial
- end stage renal disease
- rectal cancer
- free survival
- open label
- ejection fraction
- double blind
- newly diagnosed
- chronic kidney disease
- prognostic factors
- palliative care
- healthcare
- peritoneal dialysis
- phase ii
- neoadjuvant chemotherapy
- lymph node
- placebo controlled
- stem cells
- south africa
- study protocol
- patient reported outcomes
- radiation therapy
- patient reported
- replacement therapy