Article Text

Download PDFPDF

An open-label, multicohort Phase Ib trial of pembrolizumab (MK-3475) for advanced hematologic malignancies: KEYNOTE-013
  1. Vincent Ribrag1,
  2. Phillippe Armand2,
  3. John Kuruvilla3,
  4. Jean-Marie Michot1,
  5. Craig H Moskowitz4,
  6. Patricia Marinello5,
  7. Ellen Snyder5,
  8. Arun Balakumaran5,
  9. Margaret A Shipp2 and
  10. Pier Luigi Zinzani6
  1. Aff1 grid.14925.3b0000000122849388Gustave Roussy Cancer Campus Villejuif France
  2. Aff2 grid.65499.370000000121069910Dana-Farber Cancer Institute Boston MA USA
  3. Aff3 grid.231844.80000000404740428Princess Margaret Cancer Centre Toronto ON Canada
  4. Aff4 grid.51462.340000000121719952Memorial Sloan Kettering Cancer Center New York NY USA
  5. Aff5 grid.417993.10000000122600793Merck & Co., Inc. Kenilworth NJ USA
  6. Aff6 grid.6292.f0000000417571758University of Bologna Bologna Italy

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Meeting abstracts


Tumors, including hematologic malignancies, can use the PD-1 pathway to evade immune surveillance. Pembrolizumab, a highly selective, humanized monoclonal antibody that blocks interaction of PD-1 with its ligands PD-L1 and PD-L2, has demonstrated robust antitumor activity and a manageable toxicity profile in advanced solid tumors. In earlier data, pembrolizumab demonstrated efficacy in Hodgkin lymphoma (HL)[1]. KEYNOTE-013 (, NCT01953692) is a multicenter, nonrandomized, open-label, multicohort Phase Ib trial designed to assess safety and efficacy of pembrolizumab in patients with hematologic malignancies.


Cohorts include patients with intermediate-1, intermediate-2, or high-risk myelodysplastic syndrome (MDS) who failed ≥4 cycles of prior treatment with a hypomethylating agent; relapsed/refractory (R/R), multiple myeloma (MM) who failed ≥2 lines of prior therapy, including a proteasome inhibitor and IMiD; or R/R non-Hodgkin lymphoma (NHL): primary mediastinal large B cell lymphoma (MLBCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL), or any other PD-L1-positive NHL that failed, was ineligible for, or refused a stem cell transplant and R/R HL (not presented here). Key eligibility criteria: age ≥18 years; ECOG PS 0/1; measurable disease; adequate hematologic, renal, and hepatic function. Key exclusion criteria: immunosuppressive disorder, active autoimmune disease, active pneumonitis, prior anti-PD-1/anti-PD-L1 therapy, active CNS involvement, and prior allogeneic hematopoietic stem cell transplantation within 5 years). Pembrolizumab is given at 200 mg Q3W in patients enrolled under the last amendment. Treatment continues until disease progression or intolerable toxicity; clinically stable patients may continue treatment beyond radiographic or hematologic (MDS or MM) evidence of progression until confirmed in following assessment. The primary end point is objective response rate (ORR). Secondary objectives include duration of response, progression-free survival, overall survival, and association between PD-L1 expression and response. Target enrollment for DLBCL and FL cohorts is ~50 patients.

Trial registration identifier NCT01953692.


  1. 1.