Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies
← catalyst calendarNCT03233139 · readout in 407 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
146actual
Sites
20
Country
Japan
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 | 2017-06-21 | actual | When the study began enrolling |
| Primary completion | 2027-09-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-09-30 | estimated | The whole study's end, after follow-up |
| First posted | 2017-07-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Malignancies
Interventions
- Drug: Cemiplimab — also filed as REGN2810, Libtayo
- Drug: Ipilimumab
- Drug: Platinum-doublet chemotherapy
- Drug: Gemcitabine — also filed as Gemzar
- Drug: Pemetrexed — also filed as Alimta
- Drug: Paclitaxel — also filed as Taxol
- Drug: Fianlimab
Primary outcomes
what the primary-completion date above is the date OFIncidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy
measured Up to 136 weeks
Incidence and severity of TEAEs in patients treated with cemiplimab in combination with other agents
measured Up to 136 weeks
Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab without chemotherapy
measured Up to 136 weeks
Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab with chemotherapy
measured Up to 136 weeks
PK of cemiplimab: Cmax
measured Up to 136 weeks
PK of cemiplimab: tmax
measured Up to 136 weeks
PK of cemiplimab: Ctrough
measured Up to 136 weeks
PK of cemiplimab: Area under the drug concentration-time curve in serum (AUC3w)
measured Up to 136 weeks
PK of cemiplimab: t½ estimated over a 3-week dosing interval
measured Up to 136 weeks
Publications
- PMID 33146741 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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