NCT03233139

Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies

A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Cemiplimab (Anti-PD-1) and Other Agents in Japanese Patients With Advanced Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Part 2 Cohorts A and C This study is being conducted to test the safety and pharmacokinetics of cemiplimab in patients with lung cancer. The study is also being conducted to test if cemiplimab, alone or in combination, can reduce the size of your tumor by helping the immune system destroy the tumor. Part 2 Cohorts D and E This study is being conducted to test the safety and pharmacokinetics of fianlimab and cemiplimab in patients with lung cancer. The study is also being conducted to test if fianlimab and cemiplimab, with or without chemotherapy, can reduce the size of your tumor by helping the immune system destroy the tumor.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	Cemiplimab	Patients will be administered cemiplimab as per protocol. For Cohort A Only, patients with confirmed progressive disease may opt to receive up to 4 cycles of platinum doublet chemotherapy in addition to cemiplimab per investigator's judgement.
DRUG	Ipilimumab	To be administered per protocol
DRUG	Platinum-doublet chemotherapy	To be administered per protocol
DRUG	Gemcitabine	To be administered per protocol
DRUG	Pemetrexed	To be administered per protocol
DRUG	Paclitaxel	To be administered per protocol
DRUG	Fianlimab	To be administered per protocol

Timeline

• Start date: 2017-06-21
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2017-07-28
• Last updated: 2026-02-12

Locations

20 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study