At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 159 enrolled
Drug / intervention
M7824drug
Likely dose
M7824 1200 milligramsfrom 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.
A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy
EMD Serono Research & Development Institute, Inc.·interventional·Posted Feb 7, 2019·Updated Oct 25, 2023
In Brief
A Phase 2 clinical trial evaluating M7824 for Biliary Tract Cancer and 2 related conditions. Completed, enrolled 159 participants across 33 sites in 9 countries.
Detailed Summary
The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
CountriesChina, France, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsMerck KGaA, Darmstadt, Germany
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMar 2019
Primary CompletionNov 2020
Study CompletionSep 2022
TodayJul 2026
First PostedFeb 7, 2019
Enrollment StartMar 26, 2019
Primary CompletionNov 9, 2020
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.4 years ago
Interventions
M7824drug
Participants received an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.