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CERVICAL 017

Page last updated: 4/15/2020

A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with advanced, unresectable cervical cancer that progressed during or after platinum-containing chemotherapy.*

ADVANCED

 

PHASE 2

 

MONOTHERAPY

 


ClinicalTrials.gov: NCT04246489

Location: Global

Countries: Argentina, Australia, Belgium, Brazil, China, Japan, Republic of Korea, Russian Federation, Spain, and the United States

Status:

Active, not recruiting

Find a trial site near you at www.clinicaltrials.gov


Key inclusion criteria


  • Participants must have advanced unresectable and/or metastatic cervical cancer with disease progression during or after platinum-containing chemotherapy,* not received checkpoint inhibitors, and have an ECOG PS of 0 or 1
     

Key exclusion criteria


  • Participants must not have interstitial lung disease or a history of pneumonitis that required steroids




 
Study Design | Global
 

 

 

Are you interested and want to know if this trial is right for you or someone you know?

Please print or email this page.

Speak with a doctor before making a decision regarding whether a clinical trial is the right option.

    

Bintrafusp alfa is being investigated in this clinical trial. This means that it has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for bintrafusp alfa, and it includes information about how the trial is structured and how EMD Serono, a business of Merck KGaA, Darmstadt, Germany,  will determine whether bintrafusp alfa might be safe or effective. Therefore, it is important to understand that bintrafusp alfa is not a treatment or therapy for cancer or any other disease, and it has not been approved to be used by any health authority, such as the European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that bintrafusp alfa will be approved in the sought-after indication by any health authority worldwide.

You should speak with your doctor, who can help you decide whether a clinical trial might be right for you. Your doctor will be able to answer questions you might have about the risk of participating in a trial, and what other options may be available to you.

*Prior platinum-containing chemotherapy may be a systemic treatment for metastatic disease or in the adjuvant or neoadjuvant setting. Participants who were intolerant to or ineligible for platinum-based chemotherapy are also eligible for this study.
† For a full list of inclusion and exclusion criteria, please visit https://www.clinicaltrials.gov.
DOR, duration of response; DRR, durable response rate; ECOG PS, Eastern Cooperative Oncology Group performance status; IV, intravenous; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; Q2W, every 2 weeks.

References

ClinicalTrials.gov. Bintrafusp alfa monotherapy in platinum-experienced cervical cancer. https://clinicaltrials.gov/ct2/show/NCT04246489. Accessed April 15, 2020.

 

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