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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 20, 2021

Interventions

  • Biological: pembrolizumab
    • IV infusion

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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 na├»ve
  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme Corp.

Citations Reporting on Results

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.

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