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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/5/2016
Start Date:June 2015
End Date:April 2018
Contact:Toll Free Number
Phone:1-888-577-8839

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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 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.


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

- Evidence of active, non-infectious pneumonitis
We found this trial at
17
sites
Colorado Springs, Colorado 80910
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