{"preliminary_commentary":{"by_channel":{"x_thread":5,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["pembrolizumab"],["pembrolizumab","lenalidomide"]],"indication":"hematologic malignancies","name":"KEYNOTE-013","nct_id":"NCT01953692","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-013-nct01953692. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.","label":"Cohort 1: Myelodysplastic Syndrome (MDS)","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.","label":"Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.","label":"Cohort 3: Relapsed/Refractory (R/R) Hodgkin lymphoma (HL)","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.","label":"Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.","label":"Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.","label":"Cohort 4C: R/R Follicular Lymphoma (FL)","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.","label":"Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles.","label":"Cohort 5: R/R DLBCL pembrolizumab+lenalidomide 20 mg","type":"EXPERIMENTAL"},{"description":"Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.","label":"Cohort 5: R/R DLBCL pembrolizumab+lenalidomide 25 mg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2020-06-26","type":"ACTUAL"},"conditions":["Myelodysplastic Syndrome","Multiple Myeloma","Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Follicular Lymphoma","Primary Mediastinal B-Cell Lymphoma"],"enrollment":{"count":197,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pembrolizumab","otherNames":["MK-3475","KEYTRUDA®"],"type":"BIOLOGICAL"},{"name":"Lenalidomide 20 mg","otherNames":["REVLIMID®"],"type":"DRUG"},{"name":"Lenalidomide 25 mg","otherNames":["REVLIMID®"],"type":"DRUG"}],"last_update":"2021-08-04","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2020-06-26","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants Who Experienced One or More Adverse Events (AEs):","timeFrame":"Up to approximately 78.5 months"},{"measure":"Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)","timeFrame":"Up to approximately 78.5 months"},{"measure":"Objective Response Rate (ORR) in Cohort 1: Myelodysplastic Syndrome (MDS)","timeFrame":"Up to approximately 78.5 months"},{"measure":"Objective Response Rate (ORR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)","timeFrame":"Up to approximately 78.5 months"},{"measure":"Complete Remission Rate (CRR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)","timeFrame":"Up to approximately 78.5 months"},{"measure":"Objective Response Rate (ORR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)","timeFrame":"Up to approximately 78.5 months"},{"measure":"Objective Response Rate (ORR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)","timeFrame":"Up to approximately 78.5 months"},{"measure":"Objective Response Rate (ORR) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)","timeFrame":"Up to approximately 78.5 months"}],"references":[{"citation":"Armand P, Shipp MA, Ribrag V, Michot JM, Zinzani PL, Kuruvilla J, Snyder ES, Ricart AD, Balakumaran A, Rose S, Moskowitz CH. Programmed Death-1 Blockade With Pembrolizumab in Patients With Classical Hodgkin Lymphoma After Brentuximab Vedotin Failure. J Clin Oncol. 2016 Nov 1;34(31):3733-3739. doi: 10.1200/JCO.2016.67.3467.","pmid":"27354476","type":"RESULT"},{"citation":"Ribrag V, Avigan DE, Green DJ, Wise-Draper T, Posada JG, Vij R, Zhu Y, Farooqui MZH, Marinello P, Siegel DS. Phase 1b trial of pembrolizumab monotherapy for relapsed/refractory multiple myeloma: KEYNOTE-013. Br J Haematol. 2019 Aug;186(3):e41-e44. doi: 10.1111/bjh.15888. Epub 2019 Apr 1. No abstract available.","pmid":"30937889","type":"RESULT"},{"citation":"Kuruvilla J, Armand P, Hamadani M, Kline J, Moskowitz CH, Avigan D, Brody JD, Ribrag V, Herrera AF, Morschhauser F, Kanate A, Zinzani PL, Bitran J, Ghesquieres H, Schuster SJ, Farooqui M, Marinello P, Bartlett NL. Pembrolizumab for patients with non-Hodgkin lymphoma: phase 1b KEYNOTE-013 study. Leuk Lymphoma. 2023 Jan;64(1):130-139. doi: 10.1080/10428194.2022.2136956. Epub 2022 Nov 18.","pmid":"36398795","type":"DERIVED"},{"citation":"Garcia-Manero G, Ribrag V, Zhang Y, Farooqui M, Marinello P, Smith BD. Pembrolizumab for myelodysplastic syndromes after failure of hypomethylating agents in the phase 1b KEYNOTE-013 study. Leuk Lymphoma. 2022 Jul;63(7):1660-1668. doi: 10.1080/10428194.2022.2034155. Epub 2022 Mar 4.","pmid":"35244520","type":"DERIVED"},{"citation":"Griffin GK, Weirather JL, Roemer MGM, Lipschitz M, Kelley A, Chen PH, Gusenleitner D, Jeter E, Pak C, Gjini E, Chapuy B, Rosenthal MH, Xu J, Chen BJ, Sohani AR, Lovitch SB, Abramson JS, Ishizuka JJ, Kim AI, Jacobson CA, LaCasce AS, Fletcher CD, Neuberg D, Freeman GJ, Hodi FS, Wright K, Ligon AH, Jacobsen ED, Armand P, Shipp MA, Rodig SJ. Spatial signatures identify immune escape via PD-1 as a defining feature of T-cell/histiocyte-rich large B-cell lymphoma. Blood. 2021 Mar 11;137(10):1353-1364. doi: 10.1182/blood.2020006464.","pmid":"32871584","type":"DERIVED"},{"citation":"Armand P, Kuruvilla J, Michot JM, Ribrag V, Zinzani PL, Zhu Y, Marinello P, Nahar A, Moskowitz CH. KEYNOTE-013 4-year follow-up of pembrolizumab in classical Hodgkin lymphoma after brentuximab vedotin failure. Blood Adv. 2020 Jun 23;4(12):2617-2622. doi: 10.1182/bloodadvances.2019001367.","pmid":"32556281","type":"DERIVED"},{"citation":"Armand P, Rodig S, Melnichenko V, Thieblemont C, Bouabdallah K, Tumyan G, Ozcan M, Portino S, Fogliatto L, Caballero MD, Walewski J, Gulbas Z, Ribrag V, Christian B, Perini GF, Salles G, Svoboda J, Zain J, Patel S, Chen PH, Ligon AH, Ouyang J, Neuberg D, Redd R, Chatterjee A, Balakumaran A, Orlowski R, Shipp M, Zinzani PL. Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma. J Clin Oncol. 2019 Dec 1;37(34):3291-3299. doi: 10.1200/JCO.19.01389. Epub 2019 Oct 14.","pmid":"31609651","type":"DERIVED"},{"citation":"van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019 Aug 8;7(1):212. doi: 10.1186/s40425-019-0663-4.","pmid":"31395089","type":"DERIVED"},{"citation":"Zinzani PL, Ribrag V, Moskowitz CH, Michot JM, Kuruvilla J, Balakumaran A, Zhang Y, Chlosta S, Shipp MA, Armand P. Safety and tolerability of pembrolizumab in patients with relapsed/refractory primary mediastinal large B-cell lymphoma. Blood. 2017 Jul 20;130(3):267-270. doi: 10.1182/blood-2016-12-758383. Epub 2017 May 10.","pmid":"28490569","type":"DERIVED"}],"start_date":{"date":"2013-11-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)","url":"https://clinicaltrials.gov/study/NCT01953692"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-013-nct01953692"}