Trial · NCT02827838
Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer
NCT02827838, Early phase 1, Terminated, Wake Forest University Health Sciences; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer. Trials, record NCT02827838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02827838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Durvalumab Before Surgery in Treating Patients With Oral Cavity or Oropharynx Cancer
- NCT number
- NCT02827838
- Status
- Terminated
- Phases
- Early phase 1
- Enrollment
- 17 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
Human Papillomavirus Infection, Stage I Oral Cavity Squamous Cell Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Oral Cavity Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Oral Cavity Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma, Stage IVA Oral Cavity Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma
- Interventions
- Durvalumab, Laboratory Biomarker Analysis, Therapeutic Conventional Surgery
- First posted
- 2016-07-11
- Last updated
- 2025-03-17
- Results first posted
- 2025-03-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune Effector Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry | Up to 18 months | Concentration of certain immune effector will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Test |
| Primary | Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | At baseline and at one week post treatment start | Percent change of levels of immune-regulatory miRs assessed in plasma assessed pre-treatment and one week post-treatment. |
| Primary | Systemic Immune Response to HPV Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Up to 18 months | Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2- |
| Primary | Regulatory Responses Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry | Up to 18 months | Concentration of certain regulatory cells will be assessed in blood pre- and post- treatment. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. Tumor-infiltrating immune-regulator and effector cells will be quantified (0 to 3+) using standing immunofluorescence techniques. Counts and percents will be calculated for these measures overall and by HPV (+/-) groups pre- and post-treatment. Fisher exact tests will be used to compare groups at pre- and post- treatment. Stuart-Maxwell tests (generalizations of the McNemar's Tes |
| Primary | Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Baseline and one week post treatment start | Percent change of levels of immune-regulatory miRs assessed in saliva assessed pre-treatment and one week post-treatment. |
| Primary | Immune-regulatory miR Responses as Measured in Tumor Tissue Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Up to 18 months | Levels of immune-regulatory miRs assessed in blood, saliva and tumor tissue will be assessed pre- and post- treatments. Descriptive statistics, confidence intervals will be calculated and 2-sample t-tests will be performed. In addition, correlations between the different methods will be examined (i.e., correlation between saliva and blood measures, saliva and tumor measures, and blood and tumor measures). |
| Primary | Systemic Immune Response to Tumor Associated Antigens Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Up to 18 months | Lab results will be compared between patients who are HPV+ and HPV- using 2 sample t-tests. These measures will be compared in several ways. First, baseline, pre-treatment levels will be examined using descriptive statistics (n, mean, standard deviations, range). These measures will be examined overall and by HPV (+/-) groups. For each measure, and time point, 95% confidence intervals will be estimated. Next, two sample t-tests will be performed to compare levels of the measures at baseline. Next, measures taken post-treatment will be examined in a similar manner (descriptive statistics and 2- |
| Secondary | Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03 | At baseline (pre-treatment), during scheduled treatment and up to the 90-day follow up period after the last dose of study drug administered, with a median of 1 month and maximum of 13 months | AEs will be coded using the Medical Dictionary for Regulatory Activities to their organ class by preferred term. Coded AEs will be displayed by frequency, severity, and relationship to treatment (durvalumab) in the safety population. In addition, summary tables will be generated for the following situations: 1) fatigue, diarrhea, nausea and skin rash; 2) Immune-mediated reactions of any grade; 3) other adverse events graded as 3 or more by CTCAE Version 4.03; 4) Durvalumab dose reductions; 5) discontinuations of treatment with durvalumab, with specification of reason for discontinuation; and 6) changes in the surgical treatment schedule. Toxicity grades Grade I (mild), Grade II (moderate), Grade III (severe), Grade IV (life threatening) and Grade V (fatal). Toxicities of greater than or equal to Grade III (except infusion reaction) are considered worse outcomes. |
| Secondary | Standardized Uptake Value (SUV) as Measured by PET Scans | Up to 18 months | Change in SUV activity as measured by PET scans from baseline to post-treatment not specific to HPV status. |
| Secondary | Tumor Diameter Assessed Using RECIST Version 1.1 Criteria | Up to 18 months | Change in tumor diameters will be compared between groups (HPV +/-) pre- and post- treatment. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune Effector Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry | Up to 18 months | This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis. | ||
| PRIMARY | Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | At baseline and at one week post treatment start | percent change from baseline | MEDIAN | |
| PRIMARY | Systemic Immune Response to HPV Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Up to 18 months | This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis. | ||
| PRIMARY | Regulatory Responses Assessed in Blood by Flow Cytometry and in Tissue by Immunohistochemistry | Up to 18 months | This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis. | ||
| PRIMARY | Immune-regulatory miR Responses as Measured in Saliva Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Baseline and one week post treatment start | percent change from baseline | MEDIAN | |
| PRIMARY | Immune-regulatory miR Responses as Measured in Tumor Tissue Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Up to 18 months | This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis. | ||
| PRIMARY | Systemic Immune Response to Tumor Associated Antigens Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Up to 18 months | This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated and therefore is not available for analysis. | ||
| SECONDARY | Incidence of Adverse Events (AEs) as Measured by CTCAE Version 4.03 | At baseline (pre-treatment), during scheduled treatment and up to the 90-day follow up period after the last dose of study drug administered, with a median of 1 month and maximum of 13 months | events | NUMBER | |
| SECONDARY | Standardized Uptake Value (SUV) as Measured by PET Scans | Up to 18 months | This pre-specified outcome is dependent upon 1) patients having a measurable response and 2) availability of comparable cohorts of HPV positive and negative samples. Since there was a lack of measurable clinical response in all patients and the enrolled cohorts were unbalanced, the data for this outcome was not measured/evaluated for all patients. | change in SUV | MEAN |
| SECONDARY | Tumor Diameter Assessed Using RECIST Version 1.1 Criteria | Up to 18 months | mm | MEDIAN |
Source ClinicalTrials.gov
Results by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Negative | miR 146 | 27.5 | Inter-Quartile Range -24.5 to 124.2 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Positive | miR 146 | 1251.6 | Inter-Quartile Range 116.6 to 6039.3 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Negative | miR 155 | 19.7 | Inter-Quartile Range -24.2 to 364.3 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Positive | miR 155 | 814 | Inter-Quartile Range 100.7 to 2154.9 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Negative | miR 181 | 25.7 | Inter-Quartile Range 1.7 to 189.8 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Positive | miR 181 | 893.2 | Inter-Quartile Range 107.8 to 3880.8 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Negative | miR 20a | -15.6 | Inter-Quartile Range -55.2 to 6.4 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Positive | miR 20a | 520.6 | Inter-Quartile Range 43.4 to 1226.9 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Negative | miR 223 | 13.7 | Inter-Quartile Range -61.3 to 51.0 | percent change from baseline |
| Immune-regulatory miR Responses as Measured in Plasma Assessed by Quantitative Reverse Transcriptase PCR (qRT-PCR) | Treatment (Durvalumab, Surgery) - HPV Positive | miR 223 | 1031.2 | Inter-Quartile Range 43.9 to 3034.1 | percent change from baseline |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Durvalumab, Surgery) HPV Negative | 11 | |
| Overall Study | STARTED | Treatment (Durvalumab, Surgery) HPV Positive | 6 | |
| Overall Study | COMPLETED | Treatment (Durvalumab, Surgery) HPV Negative | 11 | |
| Overall Study | COMPLETED | Treatment (Durvalumab, Surgery) HPV Positive | 6 | |
| Overall Study | NOT COMPLETED | Treatment (Durvalumab, Surgery) HPV Negative | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Durvalumab, Surgery) HPV Positive | 0 |
Source ClinicalTrials.gov
Adverse events236
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 | Anemia | Blood and lymphatic system disorders | Treatment (Durvalumab, Surgery) - HPV Negative | 6 | 11 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Durvalumab, Surgery) - HPV Positive | 5 | 6 | 6 |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Durvalumab, Surgery) - HPV Negative | 1 | 11 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Durvalumab, Surgery) - HPV Positive | 1 | 6 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Treatment (Durvalumab, Surgery) - HPV Negative | 0 | 11 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Treatment (Durvalumab, Surgery) - HPV Positive | 2 | 6 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Durvalumab, Surgery) - HPV Negative | 1 | 11 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Durvalumab, Surgery) - HPV Positive | 1 | 6 | 2 |
| other | Hearing impaired | Ear and labyrinth disorders | Treatment (Durvalumab, Surgery) - HPV Negative | 1 | 11 | 1 |
| other | Hearing impaired | Ear and labyrinth disorders | Treatment (Durvalumab, Surgery) - HPV Positive | 0 | 6 | 0 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Durvalumab, Surgery) - HPV Negative | 1 | 11 |
| Total, all-cause mortality | Treatment (Durvalumab, Surgery) - HPV Positive | 0 | 6 |
| Total, other adverse events | Treatment (Durvalumab, Surgery) - HPV Negative | 11 | 11 |
| Total, other adverse events | Treatment (Durvalumab, Surgery) - HPV Positive | 6 | 6 |
| Total, serious adverse events | Treatment (Durvalumab, Surgery) - HPV Negative | 5 | 11 |
| Total, serious adverse events | Treatment (Durvalumab, Surgery) - HPV Positive | 0 | 6 |
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 |
|---|---|---|---|---|---|
| P30CA012197 | Cancer Center Support Grant | MESA, RUBEN A. | WAKE FOREST UNIVERSITY HEALTH SCIENCES | 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 |
|---|---|
| Treatment (Durvalumab, Surgery) - HPV Negative vs Treatment (Durvalumab, Surgery) - HPV Positive: deaths from any cause | Trial comparisons |
| Treatment (Durvalumab, Surgery) - HPV Negative vs Treatment (Durvalumab, Surgery) - HPV Positive: 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/NCT02827838
GET https://conductscience.org/api/trials/v1/NCT02827838/results?page=2