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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453594
• Other study ID #: 3475-087
• Secondary ID: 1530052014-00448
• Status: Completed
• Phase: Phase 2
• Start date: June 10, 2015
• Est. completion date: September 18, 2023

Study information

• Verified date: January 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Biological:
• pembrolizumab
IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

References & Publications (1)

Armand P, Zinzani PL, Lee HJ, Johnson NA, Brice P, Radford J, Ribrag V, Molin D, Vassilakopoulos TP, Tomita A, von Tresckow B, Shipp MA, Herrera AF, Lin J, Kim E, Chakraborty S, Marinello P, Moskowitz CH. Five-year follow-up of KEYNOTE-087: pembrolizumab — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)		Up to 35 months
Primary	Percentage of Participants Experiencing at Least One Adverse Event (AE)		Up to 27 months
Primary	Percentage of Participants Discontinuing Study Drug Due to AEs		Up to 24 months
Secondary	Complete Remission Rate (CRR)		Up to 35 months
Secondary	Progression-free Survival (PFS)		Up to 35 months
Secondary	Duration of Response (DOR)		Up to 35 months
Secondary	Overall Survival (OS)		Up to 35 months

External Links

•   Merck Clinical Trials Information