Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Ipilimumab: To be administered per protocol
Platinum-doublet chemotherapy: To be administered per protocol
Gemcitabine: To be administered per protocol
Pemetrexed: To be administered per protocol
Paclitaxel: To be administered per protocol
Fianlimab: To be administered per protocol
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence and severity of treatment-emergent adverse events (TEAEs) in patients treated with cemiplimab as monotherapy — Up to 136 weeks
- Incidence and severity of TEAEs in patients treated with cemiplimab in combination with other agents — Up to 136 weeks
- Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab without chemotherapy — Up to 136 weeks
- Incidence and severity of TEAEs in patients treated with fianlimab in combination with cemiplimab with chemotherapy — Up to 136 weeks
- PK of cemiplimab: Cmax — Up to 136 weeks
Peak serum concentration - PK of cemiplimab: tmax — Up to 136 weeks
Time to Cmax - PK of cemiplimab: Ctrough — Up to 136 weeks
Drug concentration in serum at the end of a dosing interval - PK of cemiplimab: Area under the drug concentration-time curve in serum (AUC3w) — Up to 136 weeks
AUC over a 3-week dosing interval - PK of cemiplimab: t½ estimated over a 3-week dosing interval — Up to 136 weeks
Observed terminal half-life
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| National Hospital Organization Nagoya Medical Center | Nagoya | Aichi-ken | |
| Kurume University Hospital | Kurume | Fukuoka | |
| Gunma Prefectural Cancer Center | Ōta | Gunma | |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | |
| Kitasato University Hospital | Sagamihara | Kanagawa | |
| Kanagawa Cardiovascular and Respiratory Center | Yokohama | Kanagawa | |
| Kanagawa Cancer Center - Thora | Yokohama | Kanagawa | |
| Sasebo City General Hospital | Sasebo | Nagasaki | |
| Kurashiki Central Hospital | Kurashiki | Okayama-ken | |
| Kansai Medical University Hirakata Hospital | Hirakata | Osaka | |
| Osaka Metropolitan University Hospital | Osaka | Osaka | |
| National Hospital Organization Kinki-chuo Chest Medical Center | Sakai-shi | Osaka | |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | Osaka | |
| Saitama Cancer Center | Shinden | Saitama | |
| National Cancer Center Hospital - Tsukiji Campus | Chuo Ku | Tokyo | |
| Hiroshima City Hiroshima Citiz | Hiroshima | Japan | |
| Nagasaki University Hospital | Nagasaki | Japan | |
| Osaka International Cancer Institute | Osaka | Japan | |
| Tokushima University Hospital | Tokushima | Japan |
On this site
📄 Libtayo (cemiplimab) drug profile →More Regeneron Pharmaceuticals trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03233139 on ClinicalTrials.gov ↗ ← All trials in Japan