Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Merck Sharp & Dohme Corp.

Intervention(s):

  • Biological: pembrolizumab

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting