File Download

There are no files associated with this item.

  Links for fulltext
     (May Require Subscription)

Conference Paper: KEYNOTE-122: Phase 2 study of pembrolizumab versus standard-of-care chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal carcinoma

TitleKEYNOTE-122: Phase 2 study of pembrolizumab versus standard-of-care chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal carcinoma
Authors
Issue Date2016
PublisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/
Citation
The 2016 ESMO Asia Congress, Singapore, 16-19 December 2016. In Annals of Oncology, 2016, v. 27 n. suppl. 9, abstract no. 394TiP How to Cite?
AbstractBACKGROUND: Current treatment for recurrent/metastatic nasopharyngeal carcinoma (NPC) that progresses on a platinum-based regimen is limited. Prolonged exposure to Epstein-Barr virus (EBV) in NPC leads to increased expression of programmed death 1 (PD-1), resulting in suppressed T-cell immunity and tumor surveillance. Pembrolizumab is a monoclonal anti–PD-1 antibody designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. In the phase 1b KEYNOTE-028 study, pembrolizumab was associated with an overall response rate of 22% (6/27) in mostly heavily pretreated patients with NPC. KEYNOTE-122 (NCT02611960) is a multicenter, open-label, randomized phase 2 study designed to evaluate the efficacy and safety of pembrolizumab monotherapy versus chemotherapy in patients with platinum-pretreated, recurrent or metastatic NPC. TRIAL DESIGN: Key eligibility criteria include age ≥18 years, histologically confirmed nonkeratinizing differentiated NPC (WHO Class II) or undifferentiated NPC (WHO Class III), metastatic or recurrent disease, EBV positivity determined locally or centrally by EBV-encoded small RNA in situ hybridization, previous treatment with platinum-containing regimen, ECOG performance status 0-1, and measurable disease per RECIST v1.1. Patients will be randomly assigned 1:1 to receive either pembrolizumab 200 mg every 3 weeks (Q3W) or investigator’s choice of chemotherapy (capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle, gemcitabine 1250 mg/m2 once per week on days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m2 Q3W). Treatment will continue until disease progression, unacceptable toxicity, investigator decision, or 35 cycles of pembrolizumab. Response will be evaluated every 6 weeks for the first year of treatment and every 9 weeks thereafter per RECIST v1.1 by central imaging assessment. Primary end points are overall survival and progression-free survival per RECIST v1.1 by central imaging assessment; secondary end points include objective response rate and duration of response. Enrollment is ongoing and will continue until approximately 160 patients have enrolled.
DescriptionThis journal suppl. entitled: Abstract Book of ESMO Asia Congress Singapore, 16–19 December 2016
Section - Head and neck cancer
Persistent Identifierhttp://hdl.handle.net/10722/241015
ISSN
2017 Impact Factor: 13.93
2015 SCImago Journal Rankings: 4.362

 

DC FieldValueLanguage
dc.contributor.authorChan, ATC-
dc.contributor.authorLee, VHF-
dc.contributor.authorNgan, R-
dc.contributor.authorTo, KF-
dc.contributor.authorAhn, MJ-
dc.contributor.authorNg, QS-
dc.contributor.authorHong, RL-
dc.contributor.authorLin, JC-
dc.contributor.authorSwaby, RF-
dc.contributor.authorGause, C-
dc.contributor.authorSaraf, S-
dc.contributor.authorSpreafico, A-
dc.date.accessioned2017-05-22T09:21:08Z-
dc.date.available2017-05-22T09:21:08Z-
dc.date.issued2016-
dc.identifier.citationThe 2016 ESMO Asia Congress, Singapore, 16-19 December 2016. In Annals of Oncology, 2016, v. 27 n. suppl. 9, abstract no. 394TiP-
dc.identifier.issn0923-7534-
dc.identifier.urihttp://hdl.handle.net/10722/241015-
dc.descriptionThis journal suppl. entitled: Abstract Book of ESMO Asia Congress Singapore, 16–19 December 2016-
dc.descriptionSection - Head and neck cancer-
dc.description.abstractBACKGROUND: Current treatment for recurrent/metastatic nasopharyngeal carcinoma (NPC) that progresses on a platinum-based regimen is limited. Prolonged exposure to Epstein-Barr virus (EBV) in NPC leads to increased expression of programmed death 1 (PD-1), resulting in suppressed T-cell immunity and tumor surveillance. Pembrolizumab is a monoclonal anti–PD-1 antibody designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. In the phase 1b KEYNOTE-028 study, pembrolizumab was associated with an overall response rate of 22% (6/27) in mostly heavily pretreated patients with NPC. KEYNOTE-122 (NCT02611960) is a multicenter, open-label, randomized phase 2 study designed to evaluate the efficacy and safety of pembrolizumab monotherapy versus chemotherapy in patients with platinum-pretreated, recurrent or metastatic NPC. TRIAL DESIGN: Key eligibility criteria include age ≥18 years, histologically confirmed nonkeratinizing differentiated NPC (WHO Class II) or undifferentiated NPC (WHO Class III), metastatic or recurrent disease, EBV positivity determined locally or centrally by EBV-encoded small RNA in situ hybridization, previous treatment with platinum-containing regimen, ECOG performance status 0-1, and measurable disease per RECIST v1.1. Patients will be randomly assigned 1:1 to receive either pembrolizumab 200 mg every 3 weeks (Q3W) or investigator’s choice of chemotherapy (capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle, gemcitabine 1250 mg/m2 once per week on days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m2 Q3W). Treatment will continue until disease progression, unacceptable toxicity, investigator decision, or 35 cycles of pembrolizumab. Response will be evaluated every 6 weeks for the first year of treatment and every 9 weeks thereafter per RECIST v1.1 by central imaging assessment. Primary end points are overall survival and progression-free survival per RECIST v1.1 by central imaging assessment; secondary end points include objective response rate and duration of response. Enrollment is ongoing and will continue until approximately 160 patients have enrolled.-
dc.languageeng-
dc.publisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/-
dc.relation.ispartofAnnals of Oncology-
dc.titleKEYNOTE-122: Phase 2 study of pembrolizumab versus standard-of-care chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal carcinoma-
dc.typeConference_Paper-
dc.identifier.emailLee, VHF: vhflee@hku.hk-
dc.identifier.authorityLee, VHF=rp00264-
dc.description.natureLink_to_subscribed_fulltext-
dc.identifier.doi10.1093/annonc/mdw587.036-
dc.identifier.hkuros272229-
dc.identifier.volume27-
dc.identifier.issuesuppl. 9, abstract no. 394TiP-
dc.publisher.placeUnited Kingdom-

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats