Trial · NCT04246489
Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
NCT04246489, Phase 2, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2023-05-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer. Trials, record NCT04246489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04246489
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer
- NCT number
- NCT04246489
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 146 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Uterine Cervical Neoplasms
- Interventions
- Bintrafusp alfa
- First posted
- 2020-01-29
- Last updated
- 2023-10-23
- Other registries' IDs
- eudract:2019-003583-40
- Results first posted
- 2023-05-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from first treatment up to 688 days | Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC. |
| Secondary | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from first treatment up to 688 days | DOR was defined for participants with confirmed response, as the time from first documentation of confirmed objective response (Complete Response \[CR\] or Partial Response \[PR\]) according to RECIST 1.1 to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates. |
| Secondary | Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from first treatment up to 688 days | Durable Response was defined as the number of participants with confirmed objective response (CR or PR) according to RECIST 1.1, determined by IRC with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Time from first treatment up to 688 days | Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious AEs and non-serious AEs. Treatment-related TEAEs: reasonably related to the study intervention. AESIs included Infusion-related reactions, Immune-related AEs, Transforming growth factor- beta (TGF-ß) inhibition mediated skin AE, bleeding and anemia. |
| Secondary | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days | PFS was defined as the time from first administration of study intervention until date of the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Kaplan-Meier estimates was used to calculate PFS. |
| Secondary | Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | Time from first treatment up to 688 days | Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by Investigator. |
| Secondary | Overall Survival (OS) | Time from first administration of study drug up to data cutoff (assessed up to 688 days) | OS was defined as the time from first administration of study intervention to the date of death due to any cause. The OS was analyzed by using the Kaplan-Meier method. |
| Secondary | Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa | At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589 | Ctrough was defined as the concentration observed immediately before next dosing (corresponding to pre-dose or trough concentration for multiple dosing). |
| Secondary | Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa | At Day 1 and Day 29 | Serum Concentration at End of Infusion (CEOI) of bintrafusp alfa is reported. |
| Secondary | Number of Participants With Positive Antidrug Antibodies (ADA) | Time from first treatment up to 688 days | Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA). Number of participants with positive ADA were reported. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from first treatment up to 688 days | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from first treatment up to 688 days | FAS included all participants who were administered at least one dose of bintrafusp alfa. | months | MEDIAN |
| SECONDARY | Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Time from first treatment up to 688 days | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Time from first treatment up to 688 days | Safety analysis set included all participants who were administered at least one dose of bintrafusp alfa | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC) | Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days | FAS included all participants who were administered at least one dose of bintrafusp alfa. | months | MEDIAN |
| SECONDARY | Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator | Time from first treatment up to 688 days | FAS included all participants who were administered at least one dose of bintrafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Time from first administration of study drug up to data cutoff (assessed up to 688 days) | FAS included all participants who were administered at least one dose of bintrafusp alfa. | months | MEDIAN |
| SECONDARY | Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa | At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589 | Pharmacokinetic (PK) analysis set included all participants who completed at least one dose of bintrafusp alfa and who provided at least one sample with a measurable concentration of bintrafusp alfa. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points for this outcome measure. | microgram per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa | At Day 1 and Day 29 | PK analysis set included all participants who completed at least one dose of Bintrafusp Alfa and who provided at least one sample with a measurable concentration of Bintrafusp Alfa. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at specified time points for this outcome measure. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Positive Antidrug Antibodies (ADA) | Time from first treatment up to 688 days | Immunogenicity analysis set included all participants who received at least one dose of bintrafusp alfa and who had at least one valid result of ADA. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Bintrafusp Alfa | 32 | Participants | ||
| Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Bintrafusp Alfa | NA | 95% Confidence Interval 7.4 to NA | months | |
| Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) | Bintrafusp Alfa | 19 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Bintrafusp Alfa | TEAE's | 145 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Bintrafusp Alfa | Treatment Related TEAEs | 106 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Bintrafusp Alfa | AESI: Infusion-related reaction | 5 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Bintrafusp Alfa | AESI: Immune-related AE | 49 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Bintrafusp Alfa | AESI: TGF-beta inhibition mediated skin AE | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Bintrafusp Alfa | AESI: Anemia | 82 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs) | Bintrafusp Alfa | AESI: Bleeding events | 81 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bintrafusp Alfa | 146 | |
| Overall Study | COMPLETED | Bintrafusp Alfa | 146 | |
| Overall Study | NOT COMPLETED | Bintrafusp Alfa | 0 |
Source ClinicalTrials.gov
Adverse events133
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Bintrafusp Alfa | 80 | 146 | |
| other | Hyperthyroidism | Endocrine disorders | Bintrafusp Alfa | 10 | 146 | |
| other | Hypothyroidism | Endocrine disorders | Bintrafusp Alfa | 17 | 146 | |
| other | Abdominal pain | Gastrointestinal disorders | Bintrafusp Alfa | 12 | 146 | |
| other | Constipation | Gastrointestinal disorders | Bintrafusp Alfa | 22 | 146 | |
| other | Diarrhoea | Gastrointestinal disorders | Bintrafusp Alfa | 12 | 146 | |
| other | Gingival bleeding | Gastrointestinal disorders | Bintrafusp Alfa | 17 | 146 | |
| other | Nausea | Gastrointestinal disorders | Bintrafusp Alfa | 30 | 146 | |
| other | Stomatitis | Gastrointestinal disorders | Bintrafusp Alfa | 10 | 146 | |
| other | Vomiting | Gastrointestinal disorders | Bintrafusp Alfa | 20 | 146 |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bintrafusp Alfa | 76 | 146 |
| Total, other adverse events | Bintrafusp Alfa | 139 | 146 |
| Total, serious adverse events | Bintrafusp Alfa | 94 | 146 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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