TriangleNCT05005429 · OUTCOME
To Evaluate the Efficacy of the Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years.
What was measured
To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 as an increase of at least 20%in the sumof thediameters of viable (enhancing) target lesions, taking as reference the smallest sumof thediameters of the viable (enhancing) target lesions. The sum must also demonstrate an absoluteincrease of at least 5 mm.
Analysis population: 47 patients were enrolled in the study although patient 05000013 was finally considered as inclusion error and did not enter in the analysis.
Groups in this outcome
Experimental: Bintrafusp Alfa (M7824)
Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals . Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
| Group | Source count |
|---|---|
| Experimental: Bintrafusp Alfa (M7824) | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Experimental: Bintrafusp Alfa (M7824) | 1.9 | Not reported | 1.7 | 5.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.7
- upper Limit
- 5.4
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 46
- units
- Participants
- description
- To determine the efficacy of M7824 in terms of the Progression Free Survival (PFS) assessed by the investigator according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 as an increase of at least 20%in the sumof thediameters of viable (enhancing) target lesions, taking as reference the smallest sumof thediameters of the viable (enhancing) target lesions. The sum must also demonstrate an absoluteincrease of at least 5 mm.
- dispersion Type
- Full Range
- groups
- description
- Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals . Treatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.
- id
- OG000
- title
- Experimental: Bintrafusp Alfa (M7824)
- param Type
- MEDIAN
- population Description
- 47 patients were enrolled in the study although patient 05000013 was finally considered as inclusion error and did not enter in the analysis.
- reporting Status
- POSTED
- time Frame
- From administration of first dose of bintrafusp alfa until objective tumor progression or death, up to 2 years.
- title
- To Evaluate the Efficacy of the Treatment
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice