Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Whether or not the patient survived progression-free for at least 6 months.

Eligible and treated patients

→

primary · POSTED

Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Eligible and treated patients.

→

primary · POSTED

Adverse Events as Assessed by NCI CTCAE v 4.0

Eligible and evaluable patients

→

secondary · POSTED

The observed length of life from entry into the study to death or the date of last contact.

Eligible and treated patients

→

secondary · POSTED

The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Eligible and treated patients

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-endometrial-cancer-keytruda-qlex-1191efca
nct id: NCT01210222
trial label: Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0000
source section id
NCT01210222-om-0000
source outcome index
0
endpoint
Progression-free Survival > 6 Months
endpoint definition
Whether or not the patient survived progression-free for at least 6 months.
time origin
At 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0001
source section id
NCT01210222-om-0001
source outcome index
1
endpoint
Objective Tumor Response (Complete or Partial Response)
endpoint definition
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
Up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0002
source section id
NCT01210222-om-0002
source outcome index
2
endpoint
Adverse Events as Assessed by NCI CTCAE v 4.0
endpoint definition
Adverse Events as Assessed by NCI CTCAE v 4.0
time origin
Up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and evaluable patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0003
source section id
NCT01210222-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
The observed length of life from entry into the study to death or the date of last contact.
time origin
From study entry to death or last contact, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0004
source section id
NCT01210222-om-0004
source outcome index
4
endpoint
Progression-free Survival
endpoint definition
The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
time origin
Patients whose disease can be evaluated by physical exam, progression was assessed prior to each cycle. CT or MRI if used to follow leasion for measurable disease, up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Eligible and treated patients
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0000
arm key
OG000
arm label
Treatment (Trebananib)
regimen
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Trebananib: Given IV
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0001
arm key
OG000
arm label
Treatment (Trebananib)
regimen
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Trebananib: Given IV
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0002
arm key
OG000
arm label
Grade 0
regimen
Number of patients who did not experience the specified AE.
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0002
arm key
OG001
arm label
Grade 1 (CTCAE v 4.0)
regimen
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0002
arm key
OG002
arm label
Grade 2 (CTCAE v 4.0)
regimen
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0002
arm key
OG003
arm label
Grade 3 (CTCAE v 4.0)
regimen
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0002#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0002
arm key
OG004
arm label
Grade 4 (CTCAE v 4.0)
regimen
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0002#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0002
arm key
OG005
arm label
Grade 5 (CTCAE v 4.0)
regimen
Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0002#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0003
arm key
OG000
arm label
Treatment (Trebananib)
regimen
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Trebananib: Given IV
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
outcome key
om-0004
arm key
OG000
arm label
Treatment (Trebananib)
regimen
Patients receive trebananib IV over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Trebananib: Given IV
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01210222-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-endometrial-cancer-keytruda-qlex-1191efca
nct id
NCT01210222
harm key
EG000
source section id
NCT01210222-ae
event group key
EG000
event group label
Treatment (Trebananib)
serious affected
14
serious at risk
32
other affected
31
other at risk
32
frequency threshold
0
collection period
AEs were collected during treatment and up to 30 days after study treatment ended. Also reported are serious adverse events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice