Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)

• ClinicalTrials.gov Identifier: NCT02453594
• Recruitment Status: Completed
• First Posted: May 25, 2015
• Last Update Posted: January 16, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: May 21, 2015
• First Posted Date: May 25, 2015
• Last Update Posted Date: January 16, 2024
• Actual Study Start Date: June 10, 2015
• Actual Primary Completion Date: September 18, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2016)

• Overall Response Rate (ORR) [ Time Frame: Up to 35 months ]
• Percentage of Participants Experiencing at Least One Adverse Event (AE) [ Time Frame: Up to 27 months ]
• Percentage of Participants Discontinuing Study Drug Due to AEs [ Time Frame: Up to 24 months ]

Original Primary Outcome Measures (submitted: May 21, 2015)

• Overall Response Rate [ Time Frame: Up to 35 months ]
• Number of Participants Experiencing at Least One Adverse Event [ Time Frame: Up to 27 months ]
• Number of Participants Discontinuing Study Treatment Due to Adverse Events [ Time Frame: Up to 24 months ]

Current Secondary Outcome Measures (submitted: October 24, 2016)

• Complete Remission Rate (CRR) [ Time Frame: Up to 35 months ]
• Progression-free Survival (PFS) [ Time Frame: Up to 35 months ]
• Duration of Response (DOR) [ Time Frame: Up to 35 months ]
• Overall Survival (OS) [ Time Frame: Up to 35 months ]

• Original Secondary Outcome Measures (submitted: May 21, 2015): Complete Remission Rate [ Time Frame: Up to 35 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)
• Official Title: A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects With Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)

Brief Summary

This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT.

The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hodgkin Lymphoma

Intervention

Biological: pembrolizumab

IV infusion

Other Names:

• MK-3475
• KEYTRUDA®

Study Arms

• Experimental: Cohort 1
  Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for up to 24 months.
  Intervention: Biological: pembrolizumab
• Experimental: Cohort 2
  Participants with RRcHL who were unable to achieve CR or PR to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months.
  Intervention: Biological: pembrolizumab
• Experimental: Cohort 3
  Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
  Intervention: Biological: pembrolizumab

Publications *

• Armand P, Zinzani PL, Lee HJ, Johnson NA, Brice P, Radford J, Ribrag V, Molin D, Vassilakopoulos TP, Tomita A, von Tresckow B, Shipp MA, Herrera AF, Lin J, Kim E, Chakraborty S, Marinello P, Moskowitz CH. Five-year follow-up of KEYNOTE-087: pembrolizumab monotherapy for relapsed/refractory classical Hodgkin lymphoma. Blood. 2023 Sep 7;142(10):878-886. doi: 10.1182/blood.2022019386.
• Chen R, Zinzani PL, Lee HJ, Armand P, Johnson NA, Brice P, Radford J, Ribrag V, Molin D, Vassilakopoulos TP, Tomita A, von Tresckow B, Shipp MA, Lin J, Kim E, Nahar A, Balakumaran A, Moskowitz CH. Pembrolizumab in relapsed or refractory Hodgkin lymphoma: 2-year follow-up of KEYNOTE-087. Blood. 2019 Oct 3;134(14):1144-1153. doi: 10.1182/blood.2019000324. Epub 2019 Aug 13.
• 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.
• von Tresckow B, Fanale M, Ardeshna KM, Chen R, Meissner J, Morschhauser F, Moskowitz C, Zinzani PL, Giezek H, Balakumaran A, Vo TT, Raut M, Brice P. Patient-reported outcomes in KEYNOTE-087, a phase 2 study of pembrolizumab in patients with classical Hodgkin lymphoma. Leuk Lymphoma. 2019 Nov;60(11):2705-2711. doi: 10.1080/10428194.2019.1602262. Epub 2019 Apr 23.
• Chen R, Zinzani PL, Fanale MA, Armand P, Johnson NA, Brice P, Radford J, Ribrag V, Molin D, Vassilakopoulos TP, Tomita A, von Tresckow B, Shipp MA, Zhang Y, Ricart AD, Balakumaran A, Moskowitz CH; KEYNOTE-087. Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma. J Clin Oncol. 2017 Jul 1;35(19):2125-2132. doi: 10.1200/JCO.2016.72.1316. Epub 2017 Apr 25.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 16, 2017): 211
• Original Estimated Enrollment (submitted: May 21, 2015): 180
• Actual Study Completion Date: September 18, 2023
• Actual Primary Completion Date: September 18, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• Relapsed or refractory de novo classical Hodgkin lymphoma
• Participant may have failed to achieve a response to, progressed after, or be ineligible for autologous stem cell transplant (auto-SCT)
• Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Measurable disease
• Adequate organ function

Exclusion criteria:

• Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
• Prior monoclonal antibody within 4 weeks prior to study Day 1 or chemotherapy, targeted small molecular therapy, or radiation therapy within 2 weeks prior to study Day 1
• Prior allogeneic hematopoietic stem cell transplantation
• Known clinically active central nervous system involvement
• Known additional malignancy that is progressing or requires active treatment
• Has a known history of Human Immunodeficiency Virus (HIV)
• Has known active Hepatitis B (HBV) or Hepatitis C (HCV)
• Active autoimmune disease requiring systemic treatment in past 2 years
• Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Australia, Austria, Canada, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Russian Federation, Spain, Sweden, United Kingdom, United States

Administrative Information

• NCT Number: NCT02453594
• Other Study ID Numbers: 3475-087; 153005 ( Registry Identifier: JAPIC-CTI ); 2014-004482-24 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: January 2024