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CERVICAL 046

Page last updated: 11/17/2020

A phase 1, open-label study evaluating bintrafusp alfa with other anticancer therapies for the treatment of patients with locally advanced or persistent, recurrent, or metastatic cervical cancer.

ADVANCED

PHASE 1

 

COMBINATION THERAPY

 


ClinicalTrials.gov: NCT04551950

Location: Global

Status:

Now Enrolling


Key inclusion criteria*


  • Participants in cohort 1 must have persistent, recurrent, or metastatic cervical cancer and not have received prior systemic chemotherapy that was not given as part of concurrent chemoradiation
  • Participants in cohort 2 must have FIGO 2018 stage IB2 to IVA cervical cancer and must not have received prior chemotherapy or radiation therapy for cervical cancer
  • Participants must have an ECOG PS of 0 or 1

Key exclusion criteria*


  • Participants must not have received prior cancer treatment with any immunotherapy, checkpoint inhibitor, or immune-modulating monoclonal antibody





 
Study design | Global
 
 
References

ClinicalTrials.gov. Bintrafusp alfa combination therapy in participants with cervical cancer (INTR@PID 046). https://clinicaltrials.gov/ct2/show/NCT04551950. Accessed November 17, 2020.

 

 

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

    

LOCATION CITY STATE POSTAL CODE COUNTRY STATUS

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 safety and efficacy of bintrafusp alfa will be measured and evaluated. 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.

Patients should speak with their doctors, who can help determine if a clinical trial might be the right option. Doctors will be able to answer patients' questions about the risk of participating in a trial, and what other options may be available to you.

*For a full list of inclusion and exclusion criteria, please visit www.clinicaltrials.gov.
†For 2 years or until confirmed disease progression, death, unacceptable toxicity, or study withdrawal.
‡Chemotherapy consists of cisplatin/carboplatin + paclitaxel.
§Concurrent chemoradiation consists of radiation therapy + cisplatin.
DLT, dose-limiting toxicity; ECOG PS, Eastern Cooperative Oncology Group performance status; FIGO, International Federation of Gynecology and Obstetrics.

 

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