A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
Completed · Phase 1
Conditions studied: Relapsed/Refractory Aggressive B-Cell Lymphoma
In brief
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)
Key facts
- Study ID
- NCT02651662
- Run by
- Regeneron Pharmaceuticals
- People needed
- 105
- Starts
- 2016-01-11
- Expected to finish
- 2026-04-29
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- 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
- Soroka — Beersheba, Israel
- Hadassah Medical Center — Jerusalem, Israel
- Chaim Sheba Medical Center — Ramat Gan, Israel
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
- Pratia MCM Krakow — Krakow, Malopolska, Poland
- Uniwersyteckie Centrum Kliniczne — Gdansk, Pomeranian Voivodeship, Poland
- Pratia Onkologia Katowice — Katowice, Poland
- Copernicus Memorial Hospital — Lodz, Poland
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa — Warsaw, Poland
- Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain
- Hospital Universitario Puerta de Hierro - Majadahonda — Majadahonda, Madrid, Spain
- Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón, Madrid, Spain
- Hospital Universitario Vall d'Hebron — Barcelona, Spain
- Hospital Clinic de Barcelona — Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
Full record on ClinicalTrials.gov
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