CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
Avelumab 3 mg/kg +2 moredrug
Likely dose
Avelumab 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01943461
NCT01943461Phase 1Completed
CompareCT.gov

A Phase I Trial to Investigate the Tolerability, Safety, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Japanese Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion Part in Asian Subjects With Gastric Cancer

Merck KGaA, Darmstadt, Germany·interventional·Posted Sep 17, 2013·Updated Sep 30, 2020

In Brief

A Phase 1 clinical trial evaluating Avelumab 3 mg/kg, Avelumab 10 mg/kg, and 1 other intervention for Solid Tumors. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 17, 2013
Enrollment StartSep 2, 2013
Primary CompletionJan 7, 2015
Study CompletionSep 25, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.8 years ago

Interventions

Avelumab 3 mg/kgdrug

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.

Avelumab 10 mg/kgdrug

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.

Avelumab 20 mg/kgdrug

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.