NCT00140855 · STUDY IN CONTEXT

A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Computed tomography (CT) scans were performed at screening, and week 10. Response was assessed using RECIST version 1.0 (Therasse P et al. J Natl Cancer Inst 92:205-216). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.

All subjects who entered the study.

→

secondary · POSTED

Blood samples were taken at baseline and weeks 4, 7, 10 and 13. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 or LAGE by enzyme-linked immunosorbent assay (ELISA). Positive results are reported as antibodies to NY-ESO-1- and/or LAGE-1-specific Total IgG (reciprocal titer).

All subjects who entered the study.

→

secondary · POSTED

All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).

All subjects who entered the study.

→

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-soft-tissue-sarcoma
nct id: NCT00140855
trial label: A Study of Anti-CTLA-4 Antibody in Patients With Advanced Synovial Sarcoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00140855
outcome key
om-0000
source section id
NCT00140855-om-0000
source outcome index
0
endpoint
Number of Subjects With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST).
endpoint definition
Computed tomography (CT) scans were performed at screening, and week 10. Response was assessed using RECIST version 1.0 (Therasse P et al. J Natl Cancer Inst 92:205-216). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.
time origin
up to 10 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All subjects who entered the study.
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-soft-tissue-sarcoma
nct id
NCT00140855
outcome key
om-0001
source section id
NCT00140855-om-0001
source outcome index
1
endpoint
Number of Subjects With NY-ESO-1 Specific Immunity as Measured by Antibody Response to NY-ESO-1 or LAGE-1
endpoint definition
Blood samples were taken at baseline and weeks 4, 7, 10 and 13. Humoral immunity was assessed by measurement of antibodies to NY-ESO-1 or LAGE by enzyme-linked immunosorbent assay (ELISA). Positive results are reported as antibodies to NY-ESO-1- and/or LAGE-1-specific Total IgG (reciprocal titer).
time origin
up to 13 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All subjects who entered the study.
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-soft-tissue-sarcoma
nct id
NCT00140855
outcome key
om-0002
source section id
NCT00140855-om-0002
source outcome index
2
endpoint
Number of Subjects Reporting Adverse Events (AEs)
endpoint definition
All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).
time origin
up to 13 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All subjects who entered the study.
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-soft-tissue-sarcoma
nct id
NCT00140855
outcome key
om-0000
arm key
OG000
arm label
Ipilimumab
regimen
Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00140855-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00140855
outcome key
om-0001
arm key
OG000
arm label
Ipilimumab
regimen
Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00140855-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00140855
outcome key
om-0002
arm key
OG000
arm label
Ipilimumab
regimen
Three doses of ipilimumab, 3 mg/kg, were administered by intravenous infusion at 3-week intervals. A 6-week observation period followed the final dose.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00140855-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-soft-tissue-sarcoma
nct id
NCT00140855
harm key
EG000
source section id
NCT00140855-ae
event group key
EG000
event group label
Ipilimumab
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
up to 13 weeks
event definition
All adverse events (AEs) which occurred after signed informed consent were documented in the source records and on the respective AE Case Report Form (CRF). Toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).
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