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

  • Interventional
  • Not Recruiting
  • NCT02453594
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02453594

IRB#IRB15-0368

Lead SponsorMerck Sharp & Dohme Corp.

Lead PhysicianJustin P. Kline

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting