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

NCT04551950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-03-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2022-06-15
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551950 on ClinicalTrials.gov