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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005084-32 | EudraCT Number | ||
| 2022-502137-26-00 | EU Trial (CTIS) Number |
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This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug[s]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs).
The study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab.
The goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation portion | Experimental |
| |
| Dose expansion portion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odronextamab | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab | A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications). | From Cycle 2, Day 1 to Cycle 2, Day 21 (each induction cycle is 21 days) |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) of REGN5837 in combination with odronextamab | Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period. | Up to approximatively 5 years |
| Severity of TEAEs of REGN5837 in combination with odronextamab | Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period. | Up to approximatively 5 years |
| Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab | An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. | Up to approximatively 5 years |
| Severity of AESIs of REGN5837 in combination with odronextamab | An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of REGN5837 in the serum | Up to 90 days post last study drug administration | |
| Concentrations of odronextamab in the serum | Up to 90 days post last study drug administration | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion / exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| University of California Los Angeles (UCLA) Medical Center |
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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| REGN5837 | Drug | Administered per the protocol |
|
| Up to approximatively 5 years |
| Occurrence of Anti-Drug Antibodies (ADAs) to REGN5837 |
| Up to 90 days post last study drug administration |
| Occurrence of ADAs to odronextamab | Up to 90 days post last study drug administration |
| Magnitude of ADAs to REGN5837 | Up to 90 days post last study drug administration |
| Magnitude of ADAs to odronextamab | Up to 90 days post last study drug administration |
| Objective Response Rate (ORR) according to the Lugano Classification of response | The ORR is defined as the proportion of patients who achieve a best overall response CR or PR during or following study treatment according to the Lugano Classification based on local investigator review. | Up to approximatively 5 years |
| Complete Response (CR) according to the Lugano Classification of response | The CR rate is defined as the proportion of patients who achieve a best overall response CR during or following study treatment according to the Lugano Classification based on local investigator review. | Up to approximatively 5 years |
| Overall Survival (OS) | OS is measured from the start of study treatment until death due to any cause. | Up to approximatively 5 years |
| Progression Free Survival (PFS) according to the Lugano Classification of response | PFS is defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review. | Up to approximatively 5 years |
| Duration of Response (DoR) according to the Lugano Classification of response | DOR is defined for responders (patients with a best overall response of CR or PR). It is the time from the date of the first documented CR or PR until the date of the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review. | Up to approximatively 5 years |
| Recruiting |
| Santa Monica |
| California |
| 90404 |
| United States |
| Norton Cancer Institute | Recruiting | Louisville | Kentucky | 40207 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Harvard Medical School - Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| NYU Langone Health Perlmutter Cancer Center | Recruiting | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| UT Southwestern | Recruiting | Dallas | Texas | 75390 | United States |
| CHU de Bordeaux | Recruiting | Talence | New Aquitaine | 33404 | France |
| Hopital Saint Louis | Recruiting | Paris | 75010 | France |
| Gustave Roussy | Recruiting | Villejuif | Île-de-France Region | 94800 | France |
| Erasmus Medical Center Rotterdam | Recruiting | Rotterdam | South Holland | 3015 | Netherlands |
| Amsterdam University Medical Centre, location AMC | Recruiting | Amsterdam | 1100AZ | Netherlands |
| Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| University Hospital and Research Institute | Recruiting | Madrid | 28041 | Spain |
| Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital | Recruiting | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Southampton General Hospital | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Western General Hospital | Recruiting | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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