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

January 12, 2024 updated by: Merck Sharp & Dohme LLC

A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects With Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
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.
Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
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.
Biological: pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2015

Primary Completion (Actual)

September 18, 2023

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimated)

May 25, 2015

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-087
  • 153005 (Registry Identifier: JAPIC-CTI)
  • 2014-004482-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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