A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
NCT ID: NCT02651662
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
105 participants
INTERVENTIONAL
2016-01-11
2026-05-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation phase
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.
cemiplimab
Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
odronextamab
Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.
Dose expansion phase
RP2D administration of the combination treatment.
cemiplimab
Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
odronextamab
Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.
Interventions
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cemiplimab
Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
odronextamab
Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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 \[MRI\]).
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
4. Adequate bone marrow and hepatic function, as defined in the protocol
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent
Exclusion Criteria
2. History of or current relevant CNS pathology, as described in the protocol
3. 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)
4. Prior therapies, as described in the protocol
5. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or other uncontrolled infection
6. Cytomegalovirus infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay until the infection is well controlled.
7. Known hypersensitivity to both allopurinol and rasburicase
8. Pregnant or breastfeeding women
9. 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
10. Patients prior diagnosis of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
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
Countries
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Other Identifiers
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2015-001697-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508209-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R1979-ONC-1504
Identifier Type: -
Identifier Source: org_study_id
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