Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display

2979 - Pembrolizumab versus brentuximab vedotin in relapsed or refractory classical Hodgkin lymphoma (cHL): randomized phase 3 KEYNOTE-204 study


08 Oct 2016


Poster Display


Michelle Fanale


Annals of Oncology (2016) 27 (6): 313-327. 10.1093/annonc/mdw375


M.A. Fanale1, J. Kline2, R. Chen3, V. Ribrag4, G. Salles5, I. Matsumura6, Y. Zhu7, A.D. Ricart7, A. Balakumaran7, P.L. Zinzani8

Author affiliations

  • 1 Department Of Medicine, The University of Texas MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 2 Hematology/oncology, University of Chicago, Chicago/US
  • 3 Hematology/oncology, City of Hope National Medical Center, Duarte/US
  • 4 Oncology, Institut Gustave Roussy, Villejuif/FR
  • 5 Hématologie, Centre Hospitalier Lyon Sud, Pierre Bénite/FR
  • 6 Department Of Internal Medicine, Kinki University, Osaka/JP
  • 7 Medical Oncology, Merck & Co, Inc., Kenilworth/US
  • 8 Medicine, University of Bologna, Bologna/IT


Abstract 2979


Patients with cHL who relapse after autologous stem-cell transplantation (auto-SCT) or are ineligible to proceed to transplantation have poor prognosis. The PD-1 ligands, PD-L1 and PD-L2, are frequently overexpressed in relapsed or refractory (R/R) cHL, and this is typically associated with chromosome 9p24.1 amplification. In the phase 1b KEYNOTE-013 study, PD-1 blockade with pembrolizumab (pembro) demonstrated an objective response rate (ORR) of 65% in heavily pretreated patients with cHL. KEYNOTE-204 (NCT02684292) is a randomized, international, open-label phase 3 study designed to compare the efficacy and safety of pembro vs brentuximab vedotin (BV) in patients with R/R cHL.

Trial design

This study will enroll patients age ≥18 years with R/R cHL who (1) have failed to achieve a response or progressed after auto-SCT and have not received prior BV; or (2) are not auto-SCT candidates because of chemo-resistant disease (unable to achieve complete or partial remission to salvage chemotherapy), advanced age, or comorbidities, and have received ≥2 prior multi-agent chemotherapy regimens that did not include BV. ∼300 patients will be randomized 1:1 to receive either pembro 200 mg Q3W or BV 1.8 mg/kg Q3W for up to 35 cycles or until documented disease progression, unacceptable toxicity, or investigator decision. Response will be assessed every 12 weeks by PET/CT scans per Revised Response Criteria for Malignant Lymphoma from the International Working Group (IWG) by central imaging vendor review. Primary end points are PFS and OS; secondary end points are ORR and complete remission rate. The primary assessment of efficacy end points will be based on blinded independent central review according to the IWG criteria; secondary/exploratory analyses of efficacy end points will be conducted using investigator assessment. Exploratory end points include PK profile, duration of response, and comparison of ORR in patients with PD-L1–positive versus PD-L1–negative lymphoid tumors. Enrollment to KEYNOTE-204 is ongoing.

Clinical trial identification


Legal entity responsible for the study

Merck & Co., Inc.


Merck & Co., Inc.


Y. Zhu, A.D. Ricart, A. Balakumaran: Employee and stock ownership at Merck & Co, Inc. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings