Trial · NCT03267680
IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
NCT03267680, Phase 2, Terminated, University of Southern California; results first posted 2025-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3. Trials, record NCT03267680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03267680
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
- NCT number
- NCT03267680
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
- Cervical Squamous Cell Carcinoma In Situ, Vulvar High Grade Squamous Intraepithelial Lesion
- Interventions
- Cyclophosphamide, Indomethacin, IRX-2, Laboratory Biomarker Analysis, Multivitamin, Omeprazole, Placebo, Therapeutic Conventional Surgery
- First posted
- 2017-08-30
- Last updated
- 2025-04-13
- Results first posted
- 2025-04-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Response | Week 25 | 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). |
| Secondary | Incidence of Adverse Events of IRX-2 Administration | Up to 30 months | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathologic Response | Week 25 | All patients who received at least 1 cycle is included. There is no statistical analysis performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Adverse Events of IRX-2 Administration | Up to 30 months | All treated patients are included | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Response | Arm I (IRX-2) | Pathologic Complete Response | 1 | Participants | |
| Pathologic Response | Arm II (Placebo) | Pathologic Complete Response | 1 | Participants | |
| Pathologic Response | Arm I (IRX-2) | Persistent CIN3/VIN3 | 6 | Participants | |
| Pathologic Response | Arm II (Placebo) | Persistent CIN3/VIN3 | 2 | Participants | |
| Incidence of Adverse Events of IRX-2 Administration | Arm I (IRX-2) | Grades 1 and 2 Adverse Events | 7 | Participants | |
| Incidence of Adverse Events of IRX-2 Administration | Arm II (Placebo) | Grades 1 and 2 Adverse Events | 3 | Participants | |
| Incidence of Adverse Events of IRX-2 Administration | Arm I (IRX-2) | Grades 3 and 4 Adverse Events | 0 | Participants | |
| Incidence of Adverse Events of IRX-2 Administration | Arm II (Placebo) | Grades 3 and 4 Adverse Events | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (IRX-2) | 7 | |
| Overall Study | STARTED | Arm II (Placebo) | 3 | |
| Overall Study | COMPLETED | Arm I (IRX-2) | 7 | |
| Overall Study | COMPLETED | Arm II (Placebo) | 3 | |
| Overall Study | NOT COMPLETED | Arm I (IRX-2) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Placebo) | 0 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Arm I (IRX-2) | 1 | 7 | |
| other | Vertigo | Ear and labyrinth disorders | Arm II (Placebo) | 0 | 3 | |
| other | Abdominal Pain | Gastrointestinal disorders | Arm I (IRX-2) | 4 | 7 | |
| other | Abdominal Pain | Gastrointestinal disorders | Arm II (Placebo) | 1 | 3 | |
| other | Constipation | Gastrointestinal disorders | Arm I (IRX-2) | 3 | 7 | |
| other | Constipation | Gastrointestinal disorders | Arm II (Placebo) | 0 | 3 | |
| other | Mucositis Oral | Gastrointestinal disorders | Arm I (IRX-2) | 2 | 7 | |
| other | Mucositis Oral | Gastrointestinal disorders | Arm II (Placebo) | 0 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | Arm I (IRX-2) | 0 | 7 | |
| other | Diarrhea | Gastrointestinal disorders | Arm II (Placebo) | 1 | 3 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (IRX-2) | 0 | 7 |
| Total, all-cause mortality | Arm II (Placebo) | 0 | 3 |
| Total, other adverse events | Arm I (IRX-2) | 7 | 7 |
| Total, other adverse events | Arm II (Placebo) | 3 | 3 |
| Total, serious adverse events | Arm I (IRX-2) | 0 | 7 |
| Total, serious adverse events | Arm II (Placebo) | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA014089 | University of Southern California Norris Comprehensive Cancer Center Support Grant (CCSG) | LERMAN, CARYN | UNIVERSITY OF SOUTHERN CALIFORNIA | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (IRX-2) vs Arm II (Placebo): deaths from any cause | Trial comparisons |
| Arm I (IRX-2) vs Arm II (Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03267680
GET https://conductscience.org/api/trials/v1/NCT03267680/events?page=2