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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

June 21, 2017

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Advanced Malignancies
Interventions
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

Trial Locations (20)

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

830-0011

Kurume University Hospital, Kurume

373-8550

Gunma Prefectural Cancer Center, Ōta

650-0047

Kobe City Medical Center General Hospital, Kobe

920-8641

Kanazawa University Hospital, Kanazawa

252-0375

Kitasato University Hospital, Sagamihara

236-0051

Kanagawa Cardiovascular and Respiratory Center, Yokohama

241-8515

Kanagawa Cancer Center - Thora, Yokohama

857-8511

Sasebo City General Hospital, Sasebo

710-8602

Kurashiki Central Hospital, Kurashiki

573-1191

Kansai Medical University Hirakata Hospital, Hirakata

545-8586

Osaka Metropolitan University Hospital, Osaka

591-8555

National Hospital Organization Kinki-chuo Chest Medical Center, Sakai-shi

569-8686

Osaka Medical and Pharmaceutical University Hospital, Takatsuki

362-0806

Saitama Cancer Center, Shinden

104-0045

National Cancer Center Hospital - Tsukiji Campus, Chuo Ku

730-8518

Hiroshima City Hiroshima Citiz, Hiroshima

852-8501

Nagasaki University Hospital, Nagasaki

541-8567

Osaka International Cancer Institute, Osaka

770-8503

Tokushima University Hospital, Tokushima

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY