NCT04551950

Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	M7824	Participants received bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator).
DRUG	Carboplatin	Carboplatin was administered intravenously as per standard of care.
DRUG	Paclitaxel	Paclitaxel was administered intravenously as per standard of care.
DRUG	Bevacizumab	Bevacizumab was administrated as indicated for standard of care.
DRUG	Cisplatin	Cisplatin was administered intravenously as per standard of care.
RADIATION	Radiotherapy	Participants received radiotherapy as per standard of care.

Timeline

• Start date: 2020-10-19
• Primary completion: 2022-06-15
• Completion: 2022-06-30
• First posted: 2020-09-16
• Last updated: 2024-03-08
• Results posted: 2024-03-08

Locations

13 sites across 3 countries: United States, Japan, Spain

Regulatory

• FDA-regulated drug study