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)

Merck Sharp & Dohme LLC203 enrolled

Overview

Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

203

Conditions

Hodgkin Lymphoma

Interventions

favezelimab/pembrolizumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (105)

The University of Arizona Cancer Center - North Campus ( Site 2216)

Tucson, Arizona, United States

UCLA Hematology/Oncology - Santa Monica ( Site 2208)

Los Angeles, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site

Torrance, California, United States

Moffitt Cancer Center ( Site 2200)

Tampa, Florida, United States

University of Kentucky Chandler Medical Center ( Site 2201)

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Progression Free Survival (PFS) Per Lugano Response Criteria as Assessed by Investigator

PFS was defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurred first. Progressive disease was defined as uptake moderately or markedly higher than the liver with an increase in overall uptake compared with nadir, and/or the appearance of new lesions consistent with lymphoma.

Time frame: Up to approximately 34 months

Secondary Outcomes

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause.

Time frame: Up to approximately 34 months

Objective Response Rate (ORR) Per Lugano Response Criteria as Assessed by Investigator

ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator. CR or PR were evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal).

Time frame: Up to approximately 34 months

Duration of Response (DOR) Per Lugano Response Criteria as Assessed by Investigator

For participants who demonstrated CR or PR per Lugano criteria 2014 as assessed by investigator, DOR was defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. CR or PR were evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal).

Time frame: Up to approximately 34 months

Number of Participants Who Experienced At Least One Adverse Event (AE)

An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is presented.

Time frame: Up to approximately 28 months

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 28 months