drugset / Trial / NCT03511391
CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors
Phase 2
Completed
99 enrolled
University Hospital, Ghent
AZ Sint-Lucas Brugge · collabAZ Sint-Lucas Gent · collabGZA Ziekenhuizen Campus Sint-Augustinus · collabJules Bordet Institute · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-03-09
- Primary completion
- 2022-02-01
- Completion
- 2024-01-23
Publications
- Results Spaas M, Sundahl N, Kruse V, Rottey S, De Maeseneer D, Duprez F, Lievens Y, Surmont V, Brochez L, Reynders D, Danckaert W, Goetghebeur E, Van den Begin R, Van Gestel D, Renard V, Dirix P, Ost P. Checkpoint Inhibitors in Combination With Stereotactic Body Radiotherapy in Patients With Advanced Solid Tumors: The CHEERS Phase 2 Randomized Clinical Trial. JAMA Oncol. 2023 Sep 1;9(9):1205-1213. doi: 10.1001/jamaoncol.2023.2132.
- Spaas M, Sundahl N, Hulstaert E, Kruse V, Rottey S, De Maeseneer D, Surmont V, Meireson A, Brochez L, Reynders D, Goetghebeur E, Van den Begin R, Van Gestel D, Renard V, Dirix P, Mestdagh P, Ost P. Checkpoint inhibition in combination with an immunoboost of external beam radiotherapy in solid tumors (CHEERS): study protocol for a phase 2, open-label, randomized controlled trial. BMC Cancer. 2021 May 7;21(1):514. doi: 10.1186/s12885-021-08088-w.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Atezolizumab | Monoclonal antibody | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |