This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: * classical Hodgkin lymphoma (cHL) * diffuse large B-cell lymphoma (DLBCL) * indolent non-Hodgkin lymphoma (iNHL) This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design. The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities. There is no primary hypothesis for this study.
Per protocol amendment 7, the secondary serum concentration endpoints were removed and will not be reported.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Administered as an IV infusion every 3 weeks (Q3W)
Administered as an IV infusion Q3W
Banner MD Anderson Cancer Center ( Site 0020)
Gilbert, Arizona, United States
City of Hope ( Site 0001)
Duarte, California, United States
Ronald Reagan UCLA Medical Center (Radiological Sciences) ( Site 0007)
Los Angeles, California, United States
Pacific Cancer Care ( Site 0006)
Monterey, California, United States
University of California San Francisco ( Site 0023)
San Francisco, California, United States
Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle and reported as the percentage of participants experiencing a DLT defined by the National Cancer Institute Common Terminology for Adverse Events version 4.0.
Time frame: Cycle 1 (up to 21 days)
Percentage of Participants Experiencing an Adverse Event (AE)
Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment
Time frame: From time of signing informed consent form (ICF) until the end of follow-up (up to approximately 27 months)
Percentage of Participants with Treatment Discontinuations Due to an AE
Percentage of participants discontinuing study treatment due to an AE
Time frame: From time of signing informed consent form (ICF) until the end of study treatment (up to approximately 24 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who had a Complete Response or a Partial Response per lymphoma disease response criteria (Cheson et. al., 2007) as assessed by the investigator.
Time frame: Up to approximately 24 months
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Dana Farber Cancer Institute ( Site 0002)
Boston, Massachusetts, United States
Fox Chase Cancer Center ( Site 0019)
Philadelphia, Pennsylvania, United States
Texas Oncology-Austin Midtown ( Site 8002)
Austin, Texas, United States
Concord Repatriation & General Hospital ( Site 0203)
Concord, New South Wales, Australia
Princess Alexandra Hospital ( Site 0204)
Woollongabba, Queensland, Australia
...and 15 more locations