NCT03190174 · STUDY IN CONTEXT

Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers

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

The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced dose-limiting toxicity (DLT), with the next higher dose level having at least two patients who experienced DLT.

Intention-to-treat population (all participant assigned to the Phase I dose escalation part of the study).

→

secondary · POSTED

The disease control rate is the percent of patients with complete response, partial response and stable disease.

Per pre-specified analysis, only participants in the expansion phase of the study were evaluated.

→

secondary · POSTED

Progression free survival is the time from start of treatment to disease progression or death.

Per pre-specified analysis, only participants in the expansion phase of the study were evaluated.

→

secondary · POSTED

The overall survival is the time from treatment initiation to death.

Per pre-specified analysis, only participants in the expansion phase of the study were evaluated.

→

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-ewing-sarcoma
nct id: NCT03190174
trial label: Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers
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: 4
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0000
source section id
NCT03190174-om-0000
source outcome index
0
endpoint
Maximum Tolerated Dose of ABI-009
endpoint definition
The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced dose-limiting toxicity (DLT), with the next higher dose level having at least two patients who experienced DLT.
time origin
Week 6
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intention-to-treat population (all participant assigned to the Phase I dose escalation part of 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-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0001
source section id
NCT03190174-om-0001
source outcome index
1
endpoint
Disease Control Rate
endpoint definition
The disease control rate is the percent of patients with complete response, partial response and stable disease.
time origin
12 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Per pre-specified analysis, only participants in the expansion phase of the study were evaluated.
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-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0002
source section id
NCT03190174-om-0002
source outcome index
2
endpoint
Progression Free Survival
endpoint definition
Progression free survival is the time from start of treatment to disease progression or death.
time origin
24 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Per pre-specified analysis, only participants in the expansion phase of the study were evaluated.
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-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0003
source section id
NCT03190174-om-0003
source outcome index
3
endpoint
Overall Survival
endpoint definition
The overall survival is the time from treatment initiation to death.
time origin
30 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Per pre-specified analysis, only participants in the expansion phase of the study were evaluated.
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-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0000
arm key
OG000
arm label
Dose Escalation Phase 1
regimen
The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level I dose - 56 mg/m\^2, in level II dose - 75 mg/m\^2, and level III dose - 100 mg/m\^2, each with defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03190174-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0001
arm key
OG000
arm label
Expansion Phase 1b
regimen
Following dose escalation, an additional 25 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 three-week cycles or until significant disease progression or unacceptable toxicity occurs.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03190174-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0002
arm key
OG000
arm label
Expansion Phase 1b
regimen
Following dose escalation, an additional 25 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 three-week cycles or until significant disease progression or unacceptable toxicity occurs.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03190174-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-ewing-sarcoma
nct id
NCT03190174
outcome key
om-0003
arm key
OG000
arm label
Expansion Phase 1b
regimen
Following dose escalation, an additional 25 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 three-week cycles or until significant disease progression or unacceptable toxicity occurs.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03190174-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-ewing-sarcoma
nct id
NCT03190174
harm key
EG000
source section id
NCT03190174-ae
event group key
EG000
event group label
Dose Escalation Phase 1 Part I
serious affected
0
serious at risk
3
other affected
0
other at risk
3
frequency threshold
0
collection period
3.8 years
event definition
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from that of the clinicaltrials.gov.
undenominated note
Source null
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-ewing-sarcoma
nct id
NCT03190174
harm key
EG001
source section id
NCT03190174-ae
event group key
EG001
event group label
Dose Escalation Phase 1 Part II
serious affected
0
serious at risk
3
other affected
0
other at risk
3
frequency threshold
0
collection period
3.8 years
event definition
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from that of the clinicaltrials.gov.
undenominated note
Source null
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-ewing-sarcoma
nct id
NCT03190174
harm key
EG002
source section id
NCT03190174-ae
event group key
EG002
event group label
Dose Escalation Phase 1 Part III
serious affected
0
serious at risk
3
other affected
0
other at risk
3
frequency threshold
0
collection period
3.8 years
event definition
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from that of the clinicaltrials.gov.
undenominated note
Source null
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-ewing-sarcoma
nct id
NCT03190174
harm key
EG003
source section id
NCT03190174-ae
event group key
EG003
event group label
Expansion Phase 1b
serious affected
3
serious at risk
25
other affected
2
other at risk
25
frequency threshold
0
collection period
3.8 years
event definition
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from that of the clinicaltrials.gov.
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