Multicenter randomized controlled phase III study of nivolumab alone or in combination with ipilimumab as immunotherapy vs standard follow-up in surgically resectable HNSCC after adjuvant therapy

Background Surgically treated locally-advanced head and neck squamous cell carcinoma (HNSCC) often requires postoperative (chemo-) radiation with high risk of acute and late toxicity. Disease-free survival (DFS) after two years is approximately 70 %. Combining anti-PD1 and anti-CTLA4 antibodies as a maintenance therapy may improve DFS due to anti-tumor effects of immunotherapy by enhancing cross-presentation of tumor antigens.

Methods IMSTAR HN (NCT03700905) is an investigator-initiated, multicenter randomized controlled phase III study. Patients with locoregional advanced HNSCC will be randomly assigned to one of the two study arms: immunotherapy (nivolumab alone or in combination with ipilimumab) vs standard of care. Standard of care consists of surgical resection followed by risk-adapted adjuvant (chemo-) radiation. In the experimental arm one neoadjuvant dose of nivolumab 3mg/kg will be applied. After treatment according to the standard arm a second randomization will be performed: In arm Ia nivolumab 3mg/kg will be given every two weeks until progression or for up to six months. In arm Ib ipilimumab 1mg/kg will be applied additionally every six weeks also until progression or for up to six months. Primary endpoint is DFS at three years. 276 patients are planned to be included.

Current status Recruitment started in August 2018. Status on October 30th 2019: seven sites open, 19 patients enrolled, initiation of three additional sites planned in Q4/2019. Due to the prolonged starting phase the initially estimated recruitment time of two years may be extended.

Poster-PDF A-1929.PDF

Publication History

Article published online:
10 June 2020