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

Introduction:

Surgically treated locally advanced head and neck squamous cell carcinoma often requires postoperative chemoradiation with high risk of acute and late toxicity. DFS after 2 years is approximately 70%. Combining anti-PD-1 and anti-CTLA4 as a maintenance therapy may improve DFS due to anti-tumor effects of immunotherapy by enhancing cross-presentation of tumor antigens.

Methods:

IMSTAR HN is an investigator initiated, multicenter randomized controlled phase III study. Patients with locoregionally advanced HNSCC will be randomly assigned to an experimental arm or a standard arm. Standard of care consists of surgical resection followed by risk-adapted adjuvant (chemo)radiation. In the experimental arm a single neoadjuvant dose with Nivolumab 3 mg/kg is applied. After treatment according to standard arm a second randomization will be performed: In Arm Ia Nivolumab 3 mg/kg will be given every 2 weeks until progression or up to 6 months. In Arm Ib Ipilimumab 1 mg/kg will be applied additionally every 6 weeks also until progression or up to 6 months. The primary endpoint is disease free survival at 3 years. 276 patients will be included in 10 centers in Germany. The study is accompagnied by a translational program that includes investigations concerning immunmodulation, mutational load in general, but also specific mutations in targets involved in immune function and antigen presentation. Recruitment started in August 2018. Clinical trial information: NCT03700905

Publication History

Publication Date:
23 April 2019 (online)