NCT03267680 · STUDY IN CONTEXT

IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3

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

Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).

All patients who received at least 1 cycle is included. There is no statistical analysis performed.

→

secondary · POSTED

Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.

All treated patients are included

→

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-squamous-cell-neoplasm
nct id: NCT03267680
trial label: IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
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: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03267680
outcome key
om-0000
source section id
NCT03267680-om-0000
source outcome index
0
endpoint
Pathologic Response
endpoint definition
Complete Response (CR) is defined as absence of intraepithelial neoplasia, Partial Response (PR) is defined as a lower grade of dysplasia than present at baseline (for example, grade 3 decreasing to grade 1).
time origin
Week 25
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients who received at least 1 cycle is included. There is no statistical analysis performed.
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-squamous-cell-neoplasm
nct id
NCT03267680
outcome key
om-0001
source section id
NCT03267680-om-0001
source outcome index
1
endpoint
Incidence of Adverse Events of IRX-2 Administration
endpoint definition
Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.
time origin
Up to 30 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All treated patients are included
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-squamous-cell-neoplasm
nct id
NCT03267680
outcome key
om-0000
arm key
OG000
arm label
Arm I (IRX-2)
regimen
Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO IRX-2: Given via submucosal injection or SC Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Therapeutic Conventional Surgery: Undergo surgical resection
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03267680-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03267680
outcome key
om-0000
arm key
OG001
arm label
Arm II (Placebo)
regimen
Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Placebo: Given via submucosal injections or SC Therapeutic Conventional Surgery: Undergo surgical resection
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03267680-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03267680
outcome key
om-0001
arm key
OG000
arm label
Arm I (IRX-2)
regimen
Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO IRX-2: Given via submucosal injection or SC Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Therapeutic Conventional Surgery: Undergo surgical resection
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03267680-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03267680
outcome key
om-0001
arm key
OG001
arm label
Arm II (Placebo)
regimen
Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection. Cyclophosphamide: Given IV Indomethacin: Given PO Laboratory Biomarker Analysis: Correlative studies Multivitamin: Given zinc-containing multivitamin PO Omeprazole: Given PO Placebo: Given via submucosal injections or SC Therapeutic Conventional Surgery: Undergo surgical resection
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03267680-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03267680
harm key
EG000
source section id
NCT03267680-ae
event group key
EG000
event group label
Arm I (IRX-2)
serious affected
0
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
30 months
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
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-neoplasm
nct id
NCT03267680
harm key
EG001
source section id
NCT03267680-ae
event group key
EG001
event group label
Arm II (Placebo)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
30 months
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