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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001697-17 | EudraCT Number | ||
| 2023-508209-25-00 | Registry Identifier | EU CT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation phase | Experimental | 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 | Experimental | RP2D administration of the combination treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cemiplimab | Drug | Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Severity of 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Odronextamab and cemiplimab concentrations in serum | Up to 18 months | |
| Incidence of anti-drug antibodies (ADAs) to odronextamab and cemiplimab over time | Up to 18 months | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States | ||
| Dana Farber/Harvard Cancer Center - PO box 849168 |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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|
| odronextamab | Drug | Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol. |
|
|
| Titer of ADAs to odronextamab and cemiplimab over time |
| 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 |
| Complete response (CR) rate as assessed by investigator | Up to 18 months |
| Duration of response as assessed by investigator | Up to 18 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Harvard Medical School - Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49546 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III | Salzburg | 5020 | Austria |
| Medical University Vienna | Vienna | 1190 | Austria |
| University Hospital Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitatsklinikum Jena | Jena | 7747 | Germany |
| Universitatsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Soroka | Beersheba | 84101 | Israel |
| Hadassah Medical Center | Jerusalem | 91200 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Pratia MCM Krakow | Krakow | Malopolska | 30-510 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Pratia Onkologia Katowice | Katowice | 40-519 | Poland |
| Copernicus Memorial Hospital | Lodz | 93-513 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa | Warsaw | 02781 | Poland |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008.0 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Institut Catala dOncologia (ICO Hospitalet) | Barcelona | 08908 | Spain |
| MD Anderson Cancer Center- Madrid | Madrid | 28033 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario de Salamanca | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000627974 | cemiplimab |
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