TriangleNCT01693562 · OUTCOME
OS 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
OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method.
Analysis population: As-treated population included all participants who received any dose of study drug. The "Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
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) | 62 |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 22 |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 304 |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 40 |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 21 |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 24 |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 51 |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 40 |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 31 |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 201 |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 20 |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 47 |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 20 |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 21 |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 62 |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 8.4 | Not reported | 5.7 | 12.3 | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 11.6 | Not reported | 3.0 | 22.8 | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 12.4 | Not reported | 9.3 | 15.2 | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 13.2 | Not reported | 6.3 | 23.0 | Not reported |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | NA | Not reported | 15.1 | 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) | 8.4 | Not reported | 4.5 | 14.3 | Not reported |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 4.9 | Not reported | 2.6 | 9.1 | Not reported |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 5.5 | Not reported | 3.5 | 16.8 | Not reported |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 5.7 | Not reported | 4.8 | 8.0 | Not reported |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 10.5 | Not reported | 6.9 | 15.7 | Not reported |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 10.0 | Not reported | 6.2 | 13.0 | Not reported |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 11.1 | Not reported | 8.2 | 16.6 | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 15.8 | Not reported | 8.1 | 23.3 | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 4.8 | Not reported | 1.3 | 10.4 | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 24.1 | Not reported | 12.4 | 37.1 | Not reported |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 16.1 | Not reported | 0.9 | NA | Upper limit of 95% CI could not be derived due to insufficient events being observed at the time of the analysis. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.7
- upper Limit
- 12.3
- value
- 8.4
- group Id
- OG001
- lower Limit
- 3.0
- upper Limit
- 22.8
- value
- 11.6
- group Id
- OG002
- lower Limit
- 9.3
- upper Limit
- 15.2
- value
- 12.4
- group Id
- OG003
- lower Limit
- 6.3
- upper Limit
- 23.0
- value
- 13.2
- 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
- 15.1
- upper Limit
- NA
- value
- NA
- group Id
- OG005
- lower Limit
- 4.5
- upper Limit
- 14.3
- value
- 8.4
- group Id
- OG006
- lower Limit
- 2.6
- upper Limit
- 9.1
- value
- 4.9
- group Id
- OG007
- lower Limit
- 3.5
- upper Limit
- 16.8
- value
- 5.5
- group Id
- OG008
- lower Limit
- 4.8
- upper Limit
- 8.0
- value
- 5.7
- group Id
- OG009
- lower Limit
- 6.9
- upper Limit
- 15.7
- value
- 10.5
- group Id
- OG010
- lower Limit
- 6.2
- upper Limit
- 13.0
- value
- 10.0
- group Id
- OG011
- lower Limit
- 8.2
- upper Limit
- 16.6
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 304
- group Id
- OG003
- value
- 40
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 24
- group Id
- OG006
- value
- 51
- group Id
- OG007
- value
- 40
- group Id
- OG008
- value
- 31
- group Id
- OG009
- value
- 201
- group Id
- OG010
- value
- 20
- group Id
- OG011
- value
- 47
- units
- Participants
- description
- OS is defined as the time from the start of study treatment until death due to any cause. The OS 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 "Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
- 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
- OS in the Dose-Expansion Phase
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice