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
