Study

Overview

Official Title: A Phase 3 Randomized Clinical Study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)

The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician’s choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician’s choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

360

Study Start Date:

October 2022

Estimated Study Completion Date:

June 2031

Estimated Primary Completion Date:

May 2027

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
Submits an archival (<5 years) or newly obtained tumor tissue sample which has not been previously irradiated.

Exclusion Criteria:

Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
History of central nervous system (CNS) metastases or active CNS involvement.
Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic treatment.
History of hemophagocytic lymphohisticytosis.
Has an active seizure disorder that is not well controlled.
Has clinically significant (ie, active) cardiovascular disease.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
Has not adequately recovered from major surgical procedure.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
History of human immunodeficiency virus (HIV).
Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.

Locations

United States Toll Free Number 1-800-770-4674

Los Angeles, California, 90404
Lexington, Kentucky, 40536
Baltimore, Maryland, 21201
Baltimore, Maryland, 21231
Ann Arbor, Michigan, 48109
New Brunswick, New Jersey, 08903
Cleveland, Ohio, 44106
Cleveland, Ohio, 44195
Pittsburgh, Pennsylvania, 15224
Pittsburgh, Pennsylvania, 15232
Seattle, Washington, 98109

Canada Study Coordinator 5143408222 ext28434

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary – MK-4280A-008

Study Detail

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician’s Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)