Trial · NCT03021993
Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
NCT03021993, Phase 2, Completed, Medical University of South Carolina; results first posted 2025-11-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer. Trials, record NCT03021993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03021993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
- NCT number
- NCT03021993
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Oral Cavity SCC
- Interventions
- Nivolumab
- First posted
- 2017-01-16
- Last updated
- 2025-11-12
- Results first posted
- 2025-11-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate Using Pathological Response | Time of surgery (day 36 or day 50) | Objective response rate: the sum of patients with either a pCR defined as no invasive and no in situ residuals present in the surgical specimen or partial pathologic response defined at least a 30% reduction in the size of the lesion in the surgical specimen. The reduction in size will be determined by comparing the pretreatment clinical measurements (the sum of the greatest axial measurement obtained with calipers at the time of initial evaluation) with the final pathologic measurements. |
| Secondary | Level of Treg Cells in Peripheral Blood Using Immunostaining | Day 1 and time of surgery (day 36 or day 50) | 1\. Levels of Treg cells in pre and post treatment peripheral blood will be evaluated using immunostaining for CD4 and flow cytometric analysis of Foxp3. Differences will be calculated (absolute change and percentage change) between pre and post treatment measures. |
| Secondary | Level of Activated T-cells in Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | 2\. Levels of activated T-cells in peripheral blood will be assessed using flow cytometry for expression of CD69, IFN γ, T-bet and ICOS in CD4+ cells. Differences will be calculated (absolute change and percentage change) between pre and post treatment measures. |
| Secondary | Level of Immune Stimulatory Cytokines in Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | 3\. Intratumoral immune activity assessed by levels of immune stimulatory cytokines including IL-2, IFN γ, and IL-12 or inhibitory cytokine, IL10 and TGF-beta, in OCSCC tumor lysates will be measured flow cytometrically by cytokine bead array. Differences will be calculated (absolute change and percentage change) between pre and post treatment measures. |
| Secondary | Expression of IFN-gamma in CD4+ Cells | Day 1 and time of surgery (day 36 or day 50) | Expression of interferon-gamma in CD4+ cells from peripheral blood of patients following PD-1 inhibition therapy will be compared between pre-treatment peripheral blood samples and post-treatment samples from the same patient. |
| Secondary | Expression of Granzyme-B in CD8+ Cells From Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | Expression of Granzyme-B in CD8+ cells from peripheral blood of patients following PD-1 inhibition therapy will be compared between pre-treatment peripheral blood samples and post-treatment samples from the same patient. |
| Secondary | Expression of CD8+ Cells Expressing Granzyme B (Cytolytic Response) From Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | 2\. Expression of CD8+ cells expressing granzyme B (cytolytic response) from peripheral blood of patients following PD-1 inhibition therapy will be compared between pre-treatment peripheral blood samples and post-treatment samples from the same patient. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate Using Pathological Response | Time of surgery (day 36 or day 50) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Level of Treg Cells in Peripheral Blood Using Immunostaining | Day 1 and time of surgery (day 36 or day 50) | Analysis includes 10 participants with complete pre- and post-treatment samples. | percentage of treg cells | MEAN |
| SECONDARY | Level of Activated T-cells in Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | Analysis includes 10 participants with complete pre- and post-treatment samples. | percentage of CD8 IFN gamma T-cells | MEAN |
| SECONDARY | Level of Immune Stimulatory Cytokines in Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | Analysis includes 10 participants with complete pre- and post-treatment samples. | percentage of cytokines | MEAN |
| SECONDARY | Expression of IFN-gamma in CD4+ Cells | Day 1 and time of surgery (day 36 or day 50) | Analysis includes 10 participants with complete pre- and post-treatment samples. | percentage of CD4 positive cells | MEAN |
| SECONDARY | Expression of Granzyme-B in CD8+ Cells From Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | Analysis includes 10 participants with complete pre- and post-treatment samples. | percentage of CD8 positive cells | MEAN |
| SECONDARY | Expression of CD8+ Cells Expressing Granzyme B (Cytolytic Response) From Peripheral Blood | Day 1 and time of surgery (day 36 or day 50) | Analysis includes 10 participants with complete pre- and post-treatment samples. | percentage of CD8+cells expressing granz | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate Using Pathological Response | Nivolumab | 4 | Participants | ||
| Level of Treg Cells in Peripheral Blood Using Immunostaining | Nivolumab | Pre-treatment | 7.7 | Standard Deviation 8.4 | percentage of treg cells |
| Level of Treg Cells in Peripheral Blood Using Immunostaining | Nivolumab | Post-treatment | 9.2 | Standard Deviation 9.1 | percentage of treg cells |
| Level of Activated T-cells in Peripheral Blood | Nivolumab | Pre-treatment | 58 | Standard Deviation 0.49 | percentage of CD8 IFN gamma T-cells |
| Level of Activated T-cells in Peripheral Blood | Nivolumab | Post-treatment | 62.2 | Standard Deviation 0.48 | percentage of CD8 IFN gamma T-cells |
| Level of Immune Stimulatory Cytokines in Peripheral Blood | Nivolumab | Pre-treatment | 26.4 | Standard Deviation 0.19 | percentage of cytokines |
| Level of Immune Stimulatory Cytokines in Peripheral Blood | Nivolumab | Post-treatment | 36.7 | Standard Deviation 0.48 | percentage of cytokines |
| Expression of IFN-gamma in CD4+ Cells | Nivolumab | Pre-treatment | 20 | Standard Deviation 12.6 | percentage of CD4 positive cells |
| Expression of IFN-gamma in CD4+ Cells | Nivolumab | Post-treatment | 23.9 | Standard Deviation 13.5 | percentage of CD4 positive cells |
| Expression of Granzyme-B in CD8+ Cells From Peripheral Blood | Nivolumab | Pre-treatment | 46.7 | Standard Deviation 15.8 | percentage of CD8 positive cells |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nivolumab | 17 | |
| Overall Study | COMPLETED | Nivolumab | 8 | |
| Overall Study | NOT COMPLETED | Nivolumab | 9 |
Source ClinicalTrials.gov
Adverse events47
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 | Painful Swelling In R Submandibular Node | General disorders | Nivolumab | 1 | 17 | 1 |
| other | Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Nivolumab | 1 | 17 | 1 |
| other | Ear Pain | Ear and labyrinth disorders | Nivolumab | 1 | 17 | 1 |
| other | Hearing Impaired | Ear and labyrinth disorders | Nivolumab | 1 | 17 | 1 |
| other | Constipation | Gastrointestinal disorders | Nivolumab | 8 | 17 | 8 |
| other | Nausea | Gastrointestinal disorders | Nivolumab | 3 | 17 | 3 |
| other | Oral Pain | General disorders | Nivolumab | 3 | 17 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Nivolumab | 2 | 17 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Nivolumab | 1 | 17 | 1 |
| other | muscositis oral | Gastrointestinal disorders | Nivolumab | 1 | 17 | 1 |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab | 3 | 17 |
| Total, other adverse events | Nivolumab | 17 | 17 |
| Total, serious adverse events | Nivolumab | 1 | 17 |
Source ClinicalTrials.gov
Papers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03021993
GET https://conductscience.org/api/trials/v1/NCT03021993/events?page=2