TriangleNCT01693562 · OUTCOME
Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- 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 BOR assessed by investigator based on RECIST v1.1 is reported. The BOR includes CR, PR, SD, PD, and NE. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
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. One participant from non-SCCHN HPV positive cohort had non-evaluable disease at baseline.
Groups in this outcome
Total Escalation/Exploration Cohort
Participants received IV infusion of MEDI4736 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg Q2W, and 15 mg/kg Q3W in the dose-escalation phase; and 20 mg/kg Q4W in the dose-exploration 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 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 |
|---|---|
| Total Escalation/Exploration Cohort | 48 |
| 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) | 302 |
| 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
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Escalation/Exploration Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 5 | Not reported | Not reported | Not reported | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 18 | Not reported | Not reported | Not reported | Not reported |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Escalation/Exploration Cohort | 4 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 6 | Not reported | Not reported | Not reported | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 49 | Not reported | Not reported | Not reported | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 24 | Not reported | Not reported | Not reported | Not reported |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 12 | Not reported | Not reported | Not reported | Not reported |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Escalation/Exploration Cohort | 18 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 14 | Not reported | Not reported | Not reported | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 7 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 102 | Not reported | Not reported | Not reported | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 22 | Not reported | Not reported | Not reported | Not reported |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 9 | Not reported | Not reported | Not reported | Not reported |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 8 | Not reported | Not reported | Not reported | Not reported |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 17 | Not reported | Not reported | Not reported | Not reported |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 8 | Not reported | Not reported | Not reported | Not reported |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 6 | Not reported | Not reported | Not reported | Not reported |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 45 | Not reported | Not reported | Not reported | Not reported |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 5 | Not reported | Not reported | Not reported | Not reported |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 18 | Not reported | Not reported | Not reported | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 8 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 27 | Not reported | Not reported | Not reported | Not reported |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Escalation/Exploration Cohort | 18 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 33 | Not reported | Not reported | Not reported | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 9 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 103 | Not reported | Not reported | Not reported | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 12 | Not reported | Not reported | Not reported | Not reported |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 5 | Not reported | Not reported | Not reported | Not reported |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 12 | Not reported | Not reported | Not reported | Not reported |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 21 | Not reported | Not reported | Not reported | Not reported |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 25 | Not reported | Not reported | Not reported | Not reported |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 17 | Not reported | Not reported | Not reported | Not reported |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 81 | Not reported | Not reported | Not reported | Not reported |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 14 | Not reported | Not reported | Not reported | Not reported |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 22 | Not reported | Not reported | Not reported | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 8 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 9 | Not reported | Not reported | Not reported | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 15 | Not reported | Not reported | Not reported | Not reported |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
NE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Escalation/Exploration Cohort | 7 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 8 | Not reported | Not reported | Not reported | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 43 | Not reported | Not reported | Not reported | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 3 | Not reported | Not reported | Not reported | Not reported |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 11 | Not reported | Not reported | Not reported | Not reported |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 6 | Not reported | Not reported | Not reported | Not reported |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 7 | Not reported | Not reported | Not reported | Not reported |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 33 | Not reported | Not reported | Not reported | Not reported |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 6 | Not reported | Not reported | Not reported | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 5 | Not reported | Not reported | Not reported | Not reported |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 2 | Not reported | Not reported | Not reported | Not reported |
Not applicable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Total Escalation/Exploration Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 18
- group Id
- OG011
- value
- 0
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 49
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 24
- group Id
- OG011
- value
- 0
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 102
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 45
- group Id
- OG011
- value
- 5
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 33
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 103
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 25
- group Id
- OG009
- value
- 17
- group Id
- OG010
- value
- 81
- group Id
- OG011
- value
- 14
- title
- PD
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 43
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 11
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 7
- group Id
- OG010
- value
- 33
- group Id
- OG011
- value
- 1
- title
- NE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Not applicable
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 62
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 302
- group Id
- OG004
- value
- 40
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 24
- group Id
- OG007
- value
- 51
- group Id
- OG008
- value
- 40
- group Id
- OG009
- value
- 31
- group Id
- OG010
- value
- 201
- group Id
- OG011
- value
- 20
- units
- Participants
- description
- The BOR assessed by investigator based on RECIST v1.1 is reported. The BOR includes CR, PR, SD, PD, and NE. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% increase in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment.
- groups
- description
- Participants received IV infusion of MEDI4736 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg Q2W, and 15 mg/kg Q3W in the dose-escalation phase; and 20 mg/kg Q4W in the dose-exploration 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
- Total Escalation/Exploration Cohort
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- 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
- OG007
- 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
- OG008
- 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
- OG009
- 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
- OG010
- 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
- OG011
- title
- Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)
- param Type
- COUNT_OF_PARTICIPANTS
- 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. One participant from non-SCCHN HPV positive cohort had non-evaluable disease at baseline.
- 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
- Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice