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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Biological: pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02453594

2014-004482-24 (EudraCT Number)

3475-087

153005 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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211 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for up to 24 months.

Treatment:

Biological: pembrolizumab

Cohort 2

Experimental group

Description:

Participants with RRcHL who were unable to achieve CR or PR to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months.

Treatment:

Biological: pembrolizumab

Cohort 3

Experimental group

Description:

Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.

Treatment:

Biological: pembrolizumab