A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
- Conditions
- Relapsed/Refractory Aggressive B-Cell Lymphoma
- Interventions
- Registration Number
- NCT02651662
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
- Have documented CD20+ aggressive B-cell NHL that is either not responsive to or relapsed after at least 2 prior lines of systemic therapy, for whom treatment with an anti-CD20 antibody may be appropriate. In addition, prior treatments should at least contain an anti-CD20 antibody and an alkylating agent.
- Must have at least 1 nodal lesion (≥1.5 cm), or at least one extranodal lesion with longest transverse diameter (LDi) greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI]).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate bone marrow and hepatic function, as defined in the protocol
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key
- Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL
- History of or current relevant CNS pathology, as described in the protocol
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (iAEs)
- Prior therapies, as described in the protocol
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
- Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay until the infection is well controlled.
- Known hypersensitivity to both allopurinol and rasburicase
- Pregnant or breastfeeding women
- Women of childbearing potential, or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose, as defined in the protocol
- Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose expansion phase odronextamab RP2D administration of the combination treatment. Dose escalation phase cemiplimab Safety assessment of odronextamab in combination with cemiplimab and selection of recommended phase 2 dose (RP2D) regimen(s) for the combination of odronextamab and cemiplimab. Dose expansion phase cemiplimab RP2D administration of the combination treatment. Dose escalation phase odronextamab Safety assessment of odronextamab in combination with cemiplimab and selection of recommended phase 2 dose (RP2D) regimen(s) for the combination of odronextamab and cemiplimab.
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab Up to 28 days Incidence of treatment emergent adverse events (TEAEs) of cemiplimab in combination with odronextamab Up to 18 months Incidence of adverse events of special interest (AESIs) of cemiplimab in combination with odronextamab Up to 18 months Severity of AESIs of cemiplimab in combination with odronextamab Up to 18 months Severity of TEAEs of cemiplimab in combination with odronextamab Up to 18 months
- Secondary Outcome Measures
Name Time Method Odronextamab and cemiplimab concentrations in serum Up to 18 months Titer of ADAs to odronextamab and cemiplimab over time Up to 18 months Complete response (CR) rate as assessed by investigator Up to 18 months Incidence of anti-drug antibodies (ADAs) to odronextamab and cemiplimab over time Up to 18 months Duration of response as assessed by investigator Up to 18 months Incidence of neutralizing antibodies (Nabs) to odronextamab and cemiplimab over time Up to 18 months Titer of Nabs to odronextamab and cemiplimab over time Up to 18 months Overall response rate as assessed by investigator Up to 18 months
Trial Locations
- Locations (39)
Copernicus Memorial Hospital
🇵🇱Lodz, Poland
Harvard Medical School - Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of California Los Angeles Medical Center
🇺🇸Santa Monica, California, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Dana Farber/Harvard Cancer Center - PO box 849168
🇺🇸Boston, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
New York Presbyterian Hospital - Weill-Cornell
🇺🇸New York, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Penn Medicine: University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
South Texas Oncology And Hematology
🇺🇸San Antonio, Texas, United States
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
🇦🇹Salzburg, Austria
Medical University Vienna
🇦🇹Vienna, Austria
Universitatsklinikum Koln
🇩🇪Koln, North Rhine Westphalia, Germany
Regeneron Research Facility
🇩🇪Heidelberg, Baden-Wurttemberg, Germany
Universitatsklinik Wurzburg, Med Klinik und Poliklinik II, Zentrum Innere Medizin
🇩🇪W rzburg, Wurzburg, Germany
University Hospital Frankfurt
🇩🇪Frankfurt am Main, Germany
Universitatsklinikum Jena
🇩🇪Jena, Germany
Universitatsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Soroka
🇮🇱Beer Sheva, 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, Pomorskie, Poland
Pratia Onkologia Katowice
🇵🇱Katowice, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
🇵🇱Warszawa, Poland
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, 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
Institut Catala dOncologia (ICO Hospitalet)
🇪🇸Barcelona, Spain
MD Anderson Cancer Center- Madrid
🇪🇸Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain