Trial · NCT02609386
IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
NCT02609386, Phase 2, Completed, Brooklyn ImmunoTherapeutics, LLC; results first posted 2024-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity. Trials, record NCT02609386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02609386
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
- NCT number
- NCT02609386
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 105 participants, actual
- Lead sponsor
- Brooklyn ImmunoTherapeutics, LLC
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity
- Interventions
- IRX-2, Cyclophosphamide, Indomethacin, Zinc-containing multivitamin, Omeprazole
- First posted
- 2015-11-20
- Last updated
- 2024-01-30
- Results first posted
- 2024-01-30
- Limitations and caveats
One of the initial secondary objectives of the study was to compare the feasibility of each booster regimen (Regimen 1 vs Regimen 2) post-surgery. However, as a significant number of patients were unable to receive booster treatments due to tolerability issues and/or their post-surgery/post-adjuvant chemoradiation therapy status, booster regimens were discontinued and analysis of booster feasibility was not performed due to insufficient data for a meaningful, statistically sound analysis.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival (EFS)- Number of Participants With an Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. |
| Primary | EFS- Time to Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | EFS is defined as the time from randomization until progression after surgery, or at surgery, if failure to resect gross disease, or at time of death from any cause after randomization. Assessment of progression/disease recurrence occurred by physical exam and annual imaging for the duration of the follow up portion of the study. Median EFS was estimated using the Kaplan-Meier method. |
| Secondary | Overall Survival (OS)- Number of Participants With an Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | OS was defined as the time from randomization to death due to any cause. |
| Secondary | OS- Time to Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | OS was defined as the time from randomization to death due to any cause. Data for partipants who were alive at the end of the study were censored at the last known alive date. Median OS was estimated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival (EFS)- Number of Participants With an Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | EFS- Time to Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS)- Number of Participants With an Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | OS- Time to Event | From randomization up until the data cut-off date of June 2, 2022 (approximately 76 months) | Months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Event-free Survival (EFS)- Number of Participants With an Event | Regimen 1 | 31 | Participants | ||
| Event-free Survival (EFS)- Number of Participants With an Event | Regimen 2 | 15 | Participants | ||
| EFS- Time to Event | Regimen 1 | 48.3 | 95% Confidence Interval 11.4 to NA | Months | |
| EFS- Time to Event | Regimen 2 | NA | 95% Confidence Interval 18.8 to NA | Months | |
| Overall Survival (OS)- Number of Participants With an Event | Regimen 1 | 19 | Participants | ||
| Overall Survival (OS)- Number of Participants With an Event | Regimen 2 | 11 | Participants | ||
| OS- Time to Event | Regimen 1 | NA | 95% Confidence Interval NA to NA | Months | |
| OS- Time to Event | Regimen 2 | NA | 95% Confidence Interval 42.6 to NA | Months |
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 | Regimen 1 | 70 | |
| Overall Study | STARTED | Regimen 2 | 35 | |
| Overall Study | COMPLETED | Regimen 1 | 42 | |
| Overall Study | COMPLETED | Regimen 2 | 18 | |
| Overall Study | NOT COMPLETED | Regimen 1 | 28 | |
| Overall Study | NOT COMPLETED | Regimen 2 | 17 |
Source ClinicalTrials.gov
Adverse events178
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 | Anaemia | Blood and lymphatic system disorders | Regimen 1 | 11 | 68 | |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 2 | 5 | 35 | |
| other | Atrial fibrillation | Cardiac disorders | Regimen 1 | 3 | 68 | |
| other | Atrial fibrillation | Cardiac disorders | Regimen 2 | 2 | 35 | |
| other | Stomatitis | Gastrointestinal disorders | Regimen 1 | 17 | 68 | |
| other | Stomatitis | Gastrointestinal disorders | Regimen 2 | 9 | 35 | |
| other | Nausea | Gastrointestinal disorders | Regimen 1 | 15 | 68 | |
| other | Nausea | Gastrointestinal disorders | Regimen 2 | 6 | 35 | |
| other | Dry mouth | Gastrointestinal disorders | Regimen 1 | 10 | 68 | |
| other | Dry mouth | Gastrointestinal disorders | Regimen 2 | 6 | 35 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen 1 | 19 | 70 |
| Total, all-cause mortality | Regimen 2 | 11 | 35 |
| Total, other adverse events | Regimen 1 | 65 | 68 |
| Total, other adverse events | Regimen 2 | 31 | 35 |
| Total, serious adverse events | Regimen 1 | 29 | 68 |
| Total, serious adverse events | Regimen 2 | 14 | 35 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regimen 1 vs Regimen 2: Event-free Survival (EFS)- Number of Participants With an Event | Trial comparisons |
| Regimen 1 vs Regimen 2: Overall Survival (OS)- Number of Participants With an Event | Trial comparisons |
| Regimen 1 vs Regimen 2: deaths from any cause | Trial comparisons |
| Regimen 1 vs Regimen 2: 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/NCT02609386
GET https://conductscience.org/api/trials/v1/NCT02609386/events?page=2