A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
← catalyst calendarSponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
105actual
Sites
30
Countries
Austria, Germany, Israel +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2016-01-11 | actual | When the study began enrolling |
| Primary completion | 2026-04-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-29 | actual | The whole study's end, after follow-up |
| First posted | 2016-01-11 | estimated | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsed/Refractory Aggressive B-Cell Lymphoma
Interventions
- Drug: cemiplimab — also filed as REGN2810, Libtayo
- Drug: odronextamab — also filed as REGN1979
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose limiting toxicities (DLTs) of cemiplimab in combination with odronextamab
measured Up to 28 days
Incidence of treatment emergent adverse events (TEAEs) of cemiplimab in combination with odronextamab
measured Up to 18 months
Severity of TEAEs of cemiplimab in combination with odronextamab
measured Up to 18 months
Incidence of adverse events of special interest (AESIs) of cemiplimab in combination with odronextamab
measured Up to 18 months
Severity of AESIs of cemiplimab in combination with odronextamab
measured Up to 18 months
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