CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
M7824 +5 moredrug
Likely dose
Not stated in 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/NCT04551950
NCT04551950Phase 1Completed

Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer (INTR@PID 046)

EMD Serono Research & Development Institute, Inc.·interventional·Posted Sep 16, 2020·Updated Mar 8, 2024

In Brief

A Phase 1 clinical trial evaluating M7824, Carboplatin, and 4 other interventions for Cervical Cancer. Completed, enrolled 25 participants across 13 sites in 3 countries.

Detailed Summary

This study was to evaluate the safety and tolerability of bintrafusp alfa in combination with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesJapan, Spain, United States

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartOct 19, 2020
Primary CompletionJun 15, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.8 years ago

Interventions

M7824drug

Participants received bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator).

Carboplatindrug

Carboplatin was administered intravenously as per standard of care.

Paclitaxeldrug

Paclitaxel was administered intravenously as per standard of care.

Bevacizumabdrug

Bevacizumab was administrated as indicated for standard of care.

Cisplatindrug

Cisplatin was administered intravenously as per standard of care.

Radiotherapyradiation

Participants received radiotherapy as per standard of care.