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

Primary Purpose

Hodgkin Lymphoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

pembrolizumab

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring PD1, PD-1, PDL1, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)

Percentage of Participants Experiencing at Least One Adverse Event (AE)

Percentage of Participants Discontinuing Study Drug Due to AEs

Secondary Outcome Measures

Complete Remission Rate (CRR)

Progression-free Survival (PFS)

Duration of Response (DOR)

Overall Survival (OS)

Full Information

NCT ID

NCT02453594

First Posted

May 21, 2015

Last Updated

September 29, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02453594

Brief Title

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

Official Title

A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects With Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 10, 2015 (Actual)

Primary Completion Date

September 18, 2023 (Actual)

Study Completion Date

September 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma

Keywords

PD1, PD-1, PDL1, PD-L1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

pembrolizumab

Other Intervention Name(s)

MK-3475, KEYTRUDA®

Intervention Description

IV infusion

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Time Frame

Up to 35 months

Title

Percentage of Participants Experiencing at Least One Adverse Event (AE)

Time Frame

Up to 27 months

Title

Percentage of Participants Discontinuing Study Drug Due to AEs

Time Frame

Up to 24 months

Secondary Outcome Measure Information:

Title

Complete Remission Rate (CRR)

Time Frame

Up to 35 months

Title

Progression-free Survival (PFS)

Time Frame

Up to 35 months

Title

Duration of Response (DOR)

Time Frame

Up to 35 months

Title

Overall Survival (OS)

Time Frame

Up to 35 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

28441111

Citation

Chen R, Zinzani PL, Fanale MA, Armand P, Johnson NA, Brice P, Radford J, Ribrag V, Molin D, Vassilakopoulos TP, Tomita A, von Tresckow B, Shipp MA, Zhang Y, Ricart AD, Balakumaran A, Moskowitz CH; KEYNOTE-087. Phase II Study of the Efficacy and Safety of Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma. J Clin Oncol. 2017 Jul 1;35(19):2125-2132. doi: 10.1200/JCO.2016.72.1316. Epub 2017 Apr 25.

Results Reference

result

PubMed Identifier

31409671

Citation

Chen R, Zinzani PL, Lee HJ, Armand P, Johnson NA, Brice P, Radford J, Ribrag V, Molin D, Vassilakopoulos TP, Tomita A, von Tresckow B, Shipp MA, Lin J, Kim E, Nahar A, Balakumaran A, Moskowitz CH. Pembrolizumab in relapsed or refractory Hodgkin lymphoma: 2-year follow-up of KEYNOTE-087. Blood. 2019 Oct 3;134(14):1144-1153. doi: 10.1182/blood.2019000324. Epub 2019 Aug 13.

Results Reference

derived

PubMed Identifier

31395089

Citation

van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019 Aug 8;7(1):212. doi: 10.1186/s40425-019-0663-4.

Results Reference

derived

PubMed Identifier

31012356

Citation

von Tresckow B, Fanale M, Ardeshna KM, Chen R, Meissner J, Morschhauser F, Moskowitz C, Zinzani PL, Giezek H, Balakumaran A, Vo TT, Raut M, Brice P. Patient-reported outcomes in KEYNOTE-087, a phase 2 study of pembrolizumab in patients with classical Hodgkin lymphoma. Leuk Lymphoma. 2019 Nov;60(11):2705-2711. doi: 10.1080/10428194.2019.1602262. Epub 2019 Apr 23.

Results Reference

derived

Links:

URL

https://www.merckclinicaltrials.com

Description

Merck Clinical Trials Information

Learn more about this trial

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

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