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
Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
IV infusion
IV infusion
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
Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator
PFS is 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 occurs first.
Time frame: Up to approximately 39 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 39 months
Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by investigator
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator.
Time frame: Up to approximately 39 months
Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator
For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by investigator, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 39 months
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE is 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 experience an AE will be presented.
Time frame: Up to approximately 25 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE is 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 discontinue study treatment due to an AE will be presented.
Time frame: Up to approximately 24 months
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University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210)
Baltimore, Maryland, United States
Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206)
Baltimore, Maryland, United States
University of Michigan ( Site 2215)
Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan ( Site 2222)
Grand Rapids, Michigan, United States
Rutgers Cancer Institute of New Jersey ( Site 2217)
New Brunswick, New Jersey, United States
...and 95 more locations