TriangleNCT03427411 · OUTCOME
Progression-free Survival Time (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from the date of first treatment to the date of disease progression or death, up to 12 months
What was measured
PFS is defined as the time from the date of first treatment to the date of disease progression or death. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
Analysis population: 1/30 participants was not evaluable in the naïve group because they were found to be HPV negative and 1/27 was not evaluable in the refractory group because one participant was a screen failure.
Groups in this outcome
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
| Group | Source count |
|---|---|
| Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 29 |
| Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 3.5 | Not reported | 1.5 | 7.4 | Not reported |
| Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 1.4 | Not reported | 0.0 | 9.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 7.4
- value
- 3.5
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 9.2
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 26
- units
- Participants
- description
- PFS is defined as the time from the date of first treatment to the date of disease progression or death. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- id
- OG000
- title
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- description
- Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- id
- OG001
- title
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- param Type
- MEDIAN
- population Description
- 1/30 participants was not evaluable in the naïve group because they were found to be HPV negative and 1/27 was not evaluable in the refractory group because one participant was a screen failure.
- reporting Status
- POSTED
- time Frame
- Time from the date of first treatment to the date of disease progression or death, up to 12 months
- title
- Progression-free Survival Time (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice