NCT03700905

Study of Nivolumab Alone or in Combination With Ipilimumab as Immunotherapy vs Standard Follow-up in Surgical Resectable HNSCC After Adjuvant Therapy

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
PROCEDURE	Surgical resection of primary tumor	Surgical resection of primary tumor including neck dissection according to standard of care
RADIATION	Adjuvant radio(-chemo)therapy	Risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only)
DRUG	Neoadjuvant Nivolumab	Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery
DRUG	Adjuvant Nivolumab	Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months
DRUG	Adjuvant Nivolumab and Ipilimumab	Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months

Timeline

• Start date: 2018-08-21
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2018-10-09
• Last updated: 2023-05-23

Locations

7 sites across 1 country: Germany