Conditions: Solid Tumors
Keywords: Solid Tumors MSB0010718C anti PD-L1 avelumab Phase 1
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 57
Healthy volunteers: no

Brief summary:
This was a Phase 1, open-label, dose-escalation trial of avelumab (antibody targeting programmed death ligand 1 \[anti PD-L1\]) in Japanese participants with metastatic or locally advanced solid tumors, followed by a consecutive expansion part in Asian participants with gastric cancer.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Avelumab 3 mg/kg intervention 2: Avelumab 10 mg/kg intervention 3: Avelumab 20 mg/kg
Intervention descriptions: intervention 1: Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred. intervention 2: Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose- escalation cohort and expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred. intervention 3: Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.

Protocol document: