TriangleNCT03427411 · OUTCOME
Duration of Response (Complete Response or Partial Response)
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 complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented, up to 12 months
What was measured
Duration of response is defined as the time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
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 | 9 |
| Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 2 |
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 | NA | Not reported | 8.3 | NA | Median and upper end of the confidence interval cannot be estimated because duration of response was censored at the time of data cut off in 6/9 responders since these 6 participants have not had disease recurrence and therefore did not have a duration of response. The other 20 participants on this cohort were not assessed for duration of response as they did not have a response to begin with. Therefore median duration of response and upper end of the confidence interval cannot be calculated. |
| Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4.0 | Not reported | 2.8 | NA | The upper end of the confidence interval cannot be estimated because of the low number of responding participants (n=2) assessed for duration of response in this cohort. In addition, the other 24 participants on this cohort were not assessed for duration of response as they did not have a response to begin with. Therefore the upper end of the confidence interval cannot be calculated. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper end of the confidence interval cannot be estimated because duration of response was censored at the time of data cut off in 6/9 responders since these 6 participants have not had disease recurrence and therefore did not have a duration of response. The other 20 participants on this cohort were not assessed for duration of response as they did not have a response to begin with. Therefore median duration of response and upper end of the confidence interval cannot be calculated.
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- NA
- value
- NA
- comment
- The upper end of the confidence interval cannot be estimated because of the low number of responding participants (n=2) assessed for duration of response in this cohort. In addition, the other 24 participants on this cohort were not assessed for duration of response as they did not have a response to begin with. Therefore the upper end of the confidence interval cannot be calculated.
- group Id
- OG001
- lower Limit
- 2.8
- upper Limit
- NA
- value
- 4.0
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Duration of response is defined as the time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression is 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
- reporting Status
- POSTED
- time Frame
- Time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented, up to 12 months
- title
- Duration of Response (Complete Response or Partial Response)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice