drugset / Trial / NCT03426657
Radiotherapy With Double Checkpoint Blockade of Locally Advanced HNSCC
NaSingle-groupOpen-labelTreatment
Summary
First-line treatment of locally advanced HNSCC with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T cell Infiltration.
Timeline
- Start
- 2018-09-20
- Primary completion
- 2021-09-16
- Completion
- 2024-02-29
Outcome
Met primary endpoint
paper CONCLUSIONS: The trial met the primary endpoint feasibility of RIT. PMID 35078923 ↗
Publications
- Beck M, Hartwich J, Eckstein M, Schmidt D, Gostian AO, Muller S, Rutzner S, Gaipl US, von der Grun J, Illmer T, Hautmann MG, Klautke G, Doscher J, Brunner T, Tamaskovics B, Hartmann A, Iro H, Kuwert T, Fietkau R, Hecht M, Semrau S. F18-FDG PET/CT imaging early predicts pathologic complete response to induction chemoimmunotherapy of locally advanced head and neck cancer: preliminary single-center analysis of the checkrad-cd8 trial. Ann Nucl Med. 2022 Jul;36(7):623-633. doi: 10.1007/s12149-022-01744-6. Epub 2022 May 10.
- Hecht M, Eckstein M, Rutzner S, von der Grun J, Illmer T, Klautke G, Laban S, Hautmann MG, Brunner TB, Tamaskovics B, Hinke A, Zhou JG, Frey B, Donaubauer AJ, Becker I, Semrau S, Hartmann A, Balermpas P, Budach W, Gaipl US, Iro H, Gostian AO, Fietkau R. Induction chemoimmunotherapy followed by CD8+ immune cell-based patient selection for chemotherapy-free radioimmunotherapy in locally advanced head and neck cancer. J Immunother Cancer. 2022 Jan;10(1):e003747. doi: 10.1136/jitc-2021-003747.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 75 mg | — |
| Subject | Tremelimumab | Monoclonal antibody | 300 mg | — |