Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)
- Interventional
- Active
- NCT02453594
Contact Information
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
- 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