KEYNOTE-224
Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial
Phase 2N = 104NCT02702414
- Population
- Patients with hepatocellular carcinoma previously treated with sorafenib (intolerant or with radiographic progression), ECOG performance status 0-1, Child-Pugh class A; 104 eligible patients enrolled and treated
- Design
- Non-randomised, multicentre, open-label phase 2 trial at 47 centres in ten countries; pembrolizumab 200 mg intravenously every 3 weeks for about 2 years or until progression or unacceptable toxicity. Primary endpoint objective response (complete or partial response by RECIST 1.1, central review) in all patients who received at least one dose.
- Primary endpoint
- ORR
- Arms
- Pembrolizumab (experimental, n = 104): Pembrolizumab 200 mg intravenously every 3 weeks
- People
- Zhu AX, KEYNOTE-224 investigators
Show the numbers
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll patients who received at least one dose of pembrolizumab | primaryZhu 2018 | 17% (11–26%) | — | 18 of 104 patients; one complete and 17 partial responses. Data cut-off 13 February 2018. |
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll patients who received at least one dose of pembrolizumab | primaryZhu 2018 | 17% (11–26%) | — | 18 of 104 patients; one complete and 17 partial responses. Data cut-off 13 February 2018. |