Safety and Pharmacokinetics of REGN2810 (Cemiplimab) (Anti-PD-1) in Japanese Patients With Advanced Malignancies
Status:
Recruiting
Trial end date:
2026-05-24
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to assess the safety, tolerability, and
Pharmacokinetics (PK) of cemiplimab in Japanese patients with advanced malignancies.
The secondary objectives are:
- To assess the immunogenicity of cemiplimab
- To evaluate tumor response (objective response rate [ORR] and duration of response [DOR]
to cemiplimab monotherapy as first line treatment of Japanese patients with advanced
squamous or non-squamous non-small cell lung cancer (NSCLC) (Part 2, cohort A)
- To evaluate tumor response ORR and DOR to cemiplimab plus chemotherapy as first line
treatment of Japanese patients with advanced squamous or non-squamous NSCLC (Part 2,
cohort C)