Pembrolizumab
BiologicalAdministered as an IV infusion every 3 weeks (Q3W)
Other names: KEYTRUDA®, MK-3475
NCT Number: NCT03598608
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Concord Repatriation & General Hospital ( Site 0203), Concord, New South Wales, Australia
Per protocol amendment 7, the secondary serum concentration endpoints were removed and will not be reported.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered as an IV infusion every 3 weeks (Q3W)
Other names: KEYTRUDA®, MK-3475
Administered as an IV infusion Q3W
Other names: MK-4280
Time frame: Cycle 1 (up to 21 days)
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: From time of signing informed consent form (ICF) until the end of follow-up (up to approximately 27 months)
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 study treatment (up to approximately 24 months)
Percentage of participants discontinuing study treatment due to an AE
Time frame: Up to approximately 24 months
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.
Merck Sharp & Dohme LLC
Industry
A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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