drugset / Trial / NCT04096911
Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer
NaSingle-groupOpen-labelTreatment
Summary
The investigators propose to evaluate the efficacy of the combination of Pd-1 Monoclonal Antibody and HPV Vaccine in the patients with cervical cancer who fails in or can not endure the standard treatment
Timeline
- Start
- 2019-07-31
- Primary completion
- 2021-03-31
- Completion
- 2021-03-31
Publications
- Results Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2.
- Results Kranawetter M, Rohrich S, Mullauer L, Obermair H, Reinthaller A, Grimm C, Sturdza A, Kostler WJ, Polterauer S. Activity of Pembrolizumab in Recurrent Cervical Cancer: Case Series and Review of Published Data. Int J Gynecol Cancer. 2018 Jul;28(6):1196-1202. doi: 10.1097/IGC.0000000000001291.
- Results Pembrolizumab OK'd for Cervical Cancer. Cancer Discov. 2018 Aug;8(8):904. doi: 10.1158/2159-8290.CD-NB2018-086. Epub 2018 Jul 2.
- Results Wang Y, Li G. PD-1/PD-L1 blockade in cervical cancer: current studies and perspectives. Front Med. 2019 Aug;13(4):438-450. doi: 10.1007/s11684-018-0674-4. Epub 2019 Mar 2.
- Wang B, Liang Y, Wu Y, Li Q, Zeng Y, Liu L, Cao W, Geng X, Huang Y, Wu Y, Pan J, Zhang X, Gu JJ. Sintilimab plus HPV vaccine for recurrent or metastatic cervical cancer. J Immunother Cancer. 2024 Nov 27;12(11):e009898. doi: 10.1136/jitc-2024-009898.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gardasil | Vaccine | — | Intramuscular |
| Subject | Sintilimab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |