Bintrafusp alfa for Uterine Cervical Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Uterine Cervical Neoplasms
Bintrafusp alfa - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will test a new drug for people with cervical cancer that has progressed despite other treatment. Researchers will evaluate how well the drug works and how safe it is.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Time from first treatment to planned final assessment at approximately 2 years

Year 2
Concentration of bintrafusp alfa at the end of Infusion (Ceoi)
Concentration of bintrfusp alfa at the end of the Dosing Interval (C trough)
Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee
Confirmed Objective Response According to RECIST Version 1.1 Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Durable Response According to RECIST Version 1.1 Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Durable Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Durable Response of at Least 6 Months According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Duration of Response (DOR) According to (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
Immunogenicity as measured by Anti-drug Antibodies Concentration
Occurrence of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related AEs, Including Adverse Events of Special Interest (AESIs)
Overall Survival (OS)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Bintrafusp alfa
1 of 1

Experimental Treatment

146 Total Participants · 1 Treatment Group

Primary Treatment: Bintrafusp alfa · No Placebo Group · Phase 2

Bintrafusp alfa
Drug
Experimental Group · 1 Intervention: Bintrafusp alfa · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp alfa
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from first treatment to planned final assessment at approximately 2 years

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
73 Previous Clinical Trials
29,828 Total Patients Enrolled
1 Trials studying Uterine Cervical Neoplasms
25 Patients Enrolled for Uterine Cervical Neoplasms
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
428 Previous Clinical Trials
112,760 Total Patients Enrolled
1 Trials studying Uterine Cervical Neoplasms
25 Patients Enrolled for Uterine Cervical Neoplasms
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
276 Previous Clinical Trials
67,034 Total Patients Enrolled
1 Trials studying Uterine Cervical Neoplasms
25 Patients Enrolled for Uterine Cervical Neoplasms

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects will be included in the study if their life expectancy is greater than or equals to 12 weeks as judged by the Investigator and they have adequate hematological, hepatic and renal function as defined in the protocol.
The patient may have been treated with platinum-containing chemotherapy before for an advanced, unresectable form of cancer that keeps coming back or spreading
People who want to participate in this study must not have any prior experience with checkpoint inhibitors.
activity People who want to participate in this study must have evidence that their disease is still active.
There is no documented evidence of multi-drug resistance that would prevent people from effectively receiving ART.
If you have an HIV viral load of less than 400 copies per milliliter at screening, you will be eligible to participate in this study.
Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.