drugset / Trial / NCT03813394
Bevacizumab and Pembrolizumab Combination in Platinum-resistant Recurrent/Metastatic NPC
Phase 1/2
Active not recruiting
48 enrolled
National University Hospital, Singapore
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a single center, randomized, phase Ib/II open-label study of pembrolizumab (pembro or MK-3475) with or without bevacizumab in patients with recurrent non-curable or metastatic nasopharyngeal carcinoma (NPC).
Timeline
- Start
- 2019-05-01
- Primary completion
- 2024-07-31
- Completion
- 2025-06-01
Outcome
Met primary endpoint
paper 58·3% [95% CI 36·6-77·9] than in the pembrolizumab group (12·5% [2·7-32·4]; unadjusted RR 4·67 [95% CI 1·54-14·18]; p=0·0010). PMID 39826567 ↗
Publications
- Background Ma BB, Hui EP, Chan AT. Systemic approach to improving treatment outcome in nasopharyngeal carcinoma: current and future directions. Cancer Sci. 2008 Jul;99(7):1311-8. doi: 10.1111/j.1349-7006.2008.00836.x. Epub 2008 May 21.
- Background Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.
- Background Zarrabi K, Fang C, Wu S. New treatment options for metastatic renal cell carcinoma with prior anti-angiogenesis therapy. J Hematol Oncol. 2017 Feb 2;10(1):38. doi: 10.1186/s13045-016-0374-y.
- Chong WQ, Low JL, Tay JK, Le TBU, Goh GS, Sooi K, Teo HL, Cheo SW, Wong RT, Samol J, Lim MY, Li H, Shirgaonkar N, Chia S, Wang L, Gopinathan A, Eu DK, Tsang RK, Loh KS, Toh HC, Syn N, Kong LR, Dasgupta R, Tai BC, Lim YC, Goh BC. Pembrolizumab with or without bevacizumab in platinum-resistant recurrent or metastatic nasopharyngeal carcinoma: a randomised, open-label, phase 2 trial. Lancet Oncol. 2025 Feb;26(2):175-186. doi: 10.1016/S1470-2045(24)00677-6. Epub 2025 Jan 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |