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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Biological: pembrolizumab


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>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. | Biological: pembrolizumab<br>* IV infusion<br>* Other names: KEYTRUDA®;|
| Experimental: Cohort 2<br>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. | Biological: pembrolizumab<br>* IV infusion<br>* Other names: KEYTRUDA®;|
| Experimental: Cohort 3<br>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. | Biological: pembrolizumab<br>* IV infusion<br>* Other names: KEYTRUDA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) |  | Up to 35 months | 
| Percentage of Participants Experiencing at Least One Adverse Event (AE) |  | Up to 27 months | 
| Percentage of Participants Discontinuing Study Drug Due to AEs |  | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission Rate (CRR) |  | Up to 35 months | 
| Progression-free Survival (PFS) |  | Up to 35 months | 
| Duration of Response (DOR) |  | Up to 35 months | 
| Overall Survival (OS) |  | Up to 35 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD1, PD-1, PDL1, PD-L1