This study is researching a combination of 2 experimental drugs, referred to as "study drugs", called odronextamab (also known as REGN1979) and cemiplimab (also known as REGN2810). The study is focused on patients who have relapse/refractory aggressive B-cell lymphoma. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose regimen for the combination with odronextamab. This study is also looking at several other research questions, including: * What side effects may happen from taking the study drugs * How effective the study drugs are against the disease * How much study drug is in the blood at different times * Whether the body makes substances or protein called antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber/Harvard Cancer Center - PO box 849168
Boston, Massachusetts, United States
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Incidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab
Time frame: Up to 28 days
Incidence of treatment emergent adverse events (TEAEs) of cemiplimab in combination with odronextamab
Time frame: Up to 18 months
Severity of TEAEs of cemiplimab in combination with odronextamab
Time frame: Up to 18 months
Incidence of adverse events of special interest (AESIs) of cemiplimab in combination with odronextamab
Time frame: Up to 18 months
Severity of AESIs of cemiplimab in combination with odronextamab
Time frame: Up to 18 months
Odronextamab and cemiplimab concentrations in serum
Time frame: Up to 18 months
Incidence of anti-drug antibodies (ADAs) to odronextamab and cemiplimab over time
Time frame: Up to 18 months
Titer of ADAs to odronextamab and cemiplimab over time
Time frame: Up to 18 months
Incidence of neutralizing antibodies (Nabs) to odronextamab and cemiplimab over time
Time frame: Up to 18 months
Titer of Nabs to odronextamab and cemiplimab over time
Time frame: Up to 18 months
Overall response rate as assessed by investigator
Time frame: Up to 18 months
Complete response (CR) rate as assessed by investigator
Time frame: Up to 18 months
Duration of response as assessed by investigator
Time frame: Up to 18 months
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Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
Salzburg, Austria
Medical University Vienna
Vienna, Austria
University Hospital Frankfurt
Frankfurt am Main, Germany
Universitatsklinikum Jena
Jena, Germany
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany
...and 20 more locations