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 |
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.
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
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