At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 146 enrolled
Drug / intervention
Bintrafusp alfadrug
Likely dose
Bintrafusp alfa 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 of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy
EMD Serono Research & Development Institute, Inc.·interventional·Posted Jan 29, 2020·Updated Oct 23, 2023
In Brief
A Phase 2 clinical trial evaluating Bintrafusp alfa for Uterine Cervical Neoplasms. Completed, enrolled 146 participants across 73 sites in 12 countries.
Detailed Summary
The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Cervical Neoplasms
CountriesArgentina, Australia, Belgium, Brazil, China, France, Hungary, Japan, Russia, South Korea, Spain, United States
CollaboratorsMerck KGaA, Darmstadt, Germany
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 2020
Enrollment StartMar 2020
Primary CompletionApr 2022
Study CompletionDec 2022
TodayJul 2026
First PostedJan 29, 2020
Enrollment StartMar 30, 2020
Primary CompletionApr 5, 2022
Study CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.4 years ago
Interventions
Bintrafusp alfadrug
Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, death, unacceptable toxicity and study withdrawal.