NCT03511391

CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors

CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors: CHEERS-trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled phase II trial will investigate whether the addition of stereotactic body radiotherapy to checkpoint inhibitor treatment in patients with non-small-cell lung carcinoma, urothelial carcinoma, renal cell carcinoma, melanoma or head-and-neck carcinoma can improve progression-free survival as compared to checkpoint inhibitor monotherapy. The primary outcome is progression-free survival; secondary outcomes include overall survival, response according to iRecist and Recist v1.1 and toxicity.

Conditions

• Urothelial Carcinoma
• Melanoma
• Renal Cell Carcinoma
• Non-small Cell Lung Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab or Pembrolizumab or Atezolizumab	per national standard of care
RADIATION	SBRT	Stereotactic body radiotherapy is administered to maximally 3 lesions in 3 fractions of 8Gy prior to the second/third cycle of checkpoint inhibitors.

Timeline

• Start date: 2018-03-09
• Primary completion: 2022-02-01
• Completion: 2024-01-23
• First posted: 2018-04-27
• Last updated: 2024-01-23

Locations

5 sites across 1 country: Belgium