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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2023-09-18

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.

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Detailed Description

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Conditions

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Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

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.

Group Type EXPERIMENTAL

pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Cohort 2

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.

Group Type EXPERIMENTAL

pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Cohort 3

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.

Group Type EXPERIMENTAL

pembrolizumab

Intervention Type BIOLOGICAL

IV infusion

Interventions

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pembrolizumab

IV infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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MK-3475 KEYTRUDA®

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No