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Clinical trial · no report yet · Phase 1
KEYNOTE-013
A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)
- NCT01953692 ↗
- Completed
- Merck Sharp & Dohme LLC
- Focused
We haven't built an HCP commentary report on KEYNOTE-013 (pembrolizumab; pembrolizumab plus lenalidomide in hematologic malignancies) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on KEYNOTE-013 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 4 | |
| Podcasts | 1 |
The trial
ClinicalTrials.gov- Official title
- A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies
- Phase
- Phase 1
- Status
- Completed
- Conditions
- Myelodysplastic Syndrome; Multiple Myeloma; Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Primary Mediastinal B-Cell Lymphoma
- Interventions
- Pembrolizumab; Lenalidomide 20 mg; Lenalidomide 25 mg
- Arms
- Cohort 1: Myelodysplastic Syndrome (MDS) · Experimental
- Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM) · Experimental
- Cohort 3: Relapsed/Refractory (R/R) Hodgkin lymphoma (HL) · Experimental
- Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) · Experimental
- Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas · Experimental
- Cohort 4C: R/R Follicular Lymphoma (FL) · Experimental
- Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) · Experimental
- Cohort 5: R/R DLBCL pembrolizumab+lenalidomide 20 mg · Experimental
- Cohort 5: R/R DLBCL pembrolizumab+lenalidomide 25 mg · Experimental
- Enrollment
- 197
- Primary outcomes
- Number of Participants Who Experienced One or More Adverse Events (AEs):
- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
- Objective Response Rate (ORR) in Cohort 1: Myelodysplastic Syndrome (MDS)
- Objective Response Rate (ORR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
- Complete Remission Rate (CRR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
- Objective Response Rate (ORR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
- Objective Response Rate (ORR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
- 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)
- Sponsor
- Merck Sharp & Dohme LLC
- Start
- Nov 22, 2013
- Primary completion
- Jun 26, 2020
- Results posted
- Yes
- Registry record
- NCT01953692 · updated Aug 4, 2021
Publications
linked from the registry- 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. PubMed 27354476
- 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. PubMed 30937889
- 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. PubMed 36398795
- 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. PubMed 35244520
- 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. PubMed 32871584
- 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. PubMed 32556281
- 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. PubMed 31609651
- 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. PubMed 31395089
- 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. PubMed 28490569