Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
Summary
This is a study of pembrolizumab (MK-3475) versus standard treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment. With Amendment 7 (effective 2-March-2022), upon study completion, participants will be discontinued and may be enrolled in an extension study.
Timeline
- Start
- 2016-04-18
- Primary completion
- 2020-11-30
- Completion
- 2022-09-30
Outcome
Missed primary endpoint
registry analysis (superiority test); Pembrolizumab vs Standard Treatment; p = 0.2262; Hazard Ratio (HR) 0.90 (95% CI 0.67 to 1.19) NCT02611960 ↗
paper Pembrolizumab did not significantly improve OS compared with chemotherapy in participants with platinum-pretreated recurrent and/or metastatic NPC PMID 36535566 ↗
Publications
- Results Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Kim SB, Ho GF, Caguioa PB, Ngamphaiboon N, Ho C, Aziz MASA, Ng QS, Yen CJ, Soparattanapaisarn N, Ngan RK, Kho SK, Tiambeng MLA, Yun T, Sriuranpong V, Algazi AP, Cheng A, Massarelli E, Swaby RF, Saraf S, Yuan J, Siu LL. Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Ann Oncol. 2023 Mar;34(3):251-261. doi: 10.1016/j.annonc.2022.12.007. Epub 2022 Dec 16.
- Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Spreafico A, Kim SB, Ho GF, Caguioa PB, Ngamphaiboon N, Swaby RF, Wei B, Webber AL, Kang J, Gumuscu B, Yuan J, Siu LL. Analysis of Plasma Epstein-Barr Virus DNA and Clinical Outcomes to Pembrolizumab or Chemotherapy in Recurrent/Metastatic Nasopharyngeal Cancer in KEYNOTE-122. Cancer Med. 2026 Feb;15(2):e71496. doi: 10.1002/cam4.71496.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |