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

Not Recruiting

Trial ID: NCT02453594

Purpose

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.

Official Title

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

Stanford Investigator(s)

Hans-Christoph Becker, MD, FSABI, FSCCT

Clinical Professor, Radiology

Neel K. Gupta
Neel K. Gupta

Clinical Assistant Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Eligibility


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

Intervention(s):

biological: pembrolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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