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Trial record 1 of 1 for:    KEYNOTE 087
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Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02453594
Recruitment Status : Active, not recruiting
First Posted : May 25, 2015
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE May 21, 2015
First Posted Date  ICMJE May 25, 2015
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE June 10, 2015
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Lymphoma
Intervention  ICMJE Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 16, 2017)
211
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)
180
Estimated Study Completion Date  ICMJE April 20, 2021
Estimated Primary Completion Date April 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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  ICMJE NCT02453594
Other Study ID Numbers  ICMJE 3475-087
2014-004482-24 ( EudraCT Number )
153005 ( Registry Identifier: JAPIC-CTI )
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  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP