TriangleNCT01693562 · OUTCOME
DoR Assessed by Investigator in the Dose-expansion Phase
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
- From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
What was measured
The DoR in participants assessed by the investigator is reported. The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.
Analysis population: As-treated population included all participants who received any dose of study drug. The DoR was analyzed for those participants who achieved OR.
Groups in this outcome
Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)
Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)
Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)
Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)
Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)
Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)
Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)
Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)
Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)
Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
| Group | Source count |
|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 7 |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 3 |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 54 |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 4 |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 3 |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 1 |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 2 |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 1 |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 1 |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 42 |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 0 |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 3 |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 2 |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 2 |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 15 |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 19.71 | Not reported | 1.9 | 44.0 | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 14.75 | Not reported | 12.8 | NA | Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 9.95 | Not reported | 8.3 | 16.4 | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 16.20 | Not reported | 7.2 | NA | Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | NA | Not reported | 7.9 | NA | Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 9.23 | Not reported | NA | NA | 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | NA | Not reported | NA | NA | Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | NA | Not reported | NA | NA | Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 5.36 | Not reported | NA | NA | 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | NA | Not reported | 14.6 | NA | Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 24.87 | Not reported | 4.8 | 24.9 | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 7.92 | Not reported | 6.1 | 9.7 | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 23.51 | Not reported | 14.6 | 32.4 | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 26.91 | Not reported | 12.7 | NA | Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 8.64 | Not reported | 4.4 | 16.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 44.0
- value
- 19.71
- comment
- Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG001
- lower Limit
- 12.8
- upper Limit
- NA
- value
- 14.75
- group Id
- OG002
- lower Limit
- 8.3
- upper Limit
- 16.4
- value
- 9.95
- comment
- Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG003
- lower Limit
- 7.2
- upper Limit
- NA
- value
- 16.20
- comment
- Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG004
- lower Limit
- 7.9
- upper Limit
- NA
- value
- NA
- comment
- 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- 9.23
- comment
- Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG006
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG008
- lower Limit
- NA
- upper Limit
- NA
- value
- 5.36
- comment
- Median and Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis.
- group Id
- OG009
- lower Limit
- 14.6
- upper Limit
- NA
- value
- NA
- group Id
- OG011
- lower Limit
- 4.8
- upper Limit
- 24.9
- value
- 24.87
- group Id
- OG012
- lower Limit
- 6.1
- upper Limit
- 9.7
- value
- 7.92
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 54
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 42
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- The DoR in participants assessed by the investigator is reported. The DoR is defined as the duration from the first documentation of OR (confirmed CR or confirmed PR) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. A confirmed CR is defined as two CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs (\>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG000
- title
- Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG001
- title
- Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG002
- title
- Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG003
- title
- Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG004
- title
- Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG005
- title
- Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG006
- title
- Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG007
- title
- Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG008
- title
- Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG009
- title
- Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG010
- title
- Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)
- description
- Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
- id
- OG011
- title
- Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)
- param Type
- MEDIAN
- population Description
- As-treated population included all participants who received any dose of study drug. The DoR was analyzed for those participants who achieved OR.
- reporting Status
- POSTED
- time Frame
- From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)
- title
- DoR Assessed by Investigator in the Dose-expansion Phase
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice