Trial · NCT02538510
Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery
NCT02538510, Phase 1, Phase 2, Completed, University of Washington; results first posted 2020-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery. Trials, record NCT02538510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02538510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery
- NCT number
- NCT02538510
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Head and Neck Squamous Cell Carcinoma, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharynx Carcinoma, Recurrent Salivary Gland Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage III Major Salivary Gland Carcinoma, Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage III Nasopharyngeal Carcinoma, Stage IV Nasopharyngeal Carcinoma, Stage IVA Major Salivary Gland Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Major Salivary Gland Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Major Salivary Gland Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
- Interventions
- Laboratory Biomarker Analysis, Pembrolizumab, Vorinostat
- First posted
- 2015-09-02
- Last updated
- 2024-11-26
- Results first posted
- 2020-10-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 30 days after the completion of study treatment | Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0 |
| Secondary | Objective Response Rate | Up to 2 years | Radiologic assessments of measurable disease will be performed using radiographic imaging. RECIST 1.1 and immune response criteria will be used to assess response to therapy. Responses will be summarized as frequencies and percentages. |
| Secondary | Overall Survival | Up to 7 years 6 months | The Kaplan Meier methods will be used to estimate overall survival. |
| Secondary | Progression Free Survival | Up to 2 years | The Kaplan Meier methods will be used to estimate progression free survival. |
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 | Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 30 days after the completion of study treatment | Only G3 toxicities and toxicities requiring dose hold/reduction recorded. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate | Up to 2 years | 6 patients were not evaluated as they did not have at least 1 set of follow up scans while on study, (N=2 salivary patients, N=4 SCC patients) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to 7 years 6 months | Months | MEAN | |
| SECONDARY | Progression Free Survival | Up to 2 years | Months | MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Head and Neck Squamous Cell Carcinoma | Adrenal insufficiency | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Salivary Gland Carcinoma | Adrenal insufficiency | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Head and Neck Squamous Cell Carcinoma | ALT increase | 0 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Salivary Gland Carcinoma | ALT increase | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Head and Neck Squamous Cell Carcinoma | Anorexia | 0 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Salivary Gland Carcinoma | Anorexia | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Head and Neck Squamous Cell Carcinoma | Arthiritis | 0 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Salivary Gland Carcinoma | Arthiritis | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Head and Neck Squamous Cell Carcinoma | AST increase | 0 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Salivary Gland Carcinoma | AST increase | 1 | Participants |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Head and Neck Squamous Cell Carcinoma | 25 | |
| Overall Study | STARTED | Salivary Gland Carcinoma | 25 | |
| Overall Study | COMPLETED | Head and Neck Squamous Cell Carcinoma | 25 | |
| Overall Study | COMPLETED | Salivary Gland Carcinoma | 25 | |
| Overall Study | NOT COMPLETED | Head and Neck Squamous Cell Carcinoma | 0 | |
| Overall Study | NOT COMPLETED | Salivary Gland Carcinoma | 0 |
Source ClinicalTrials.gov
Adverse events28
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 | alanine amintotransferase (ALT) increased | Hepatobiliary disorders | Head and Neck Squamous Cell Carcinoma | 0 | 25 | 0 |
| other | alanine amintotransferase (ALT) increased | Hepatobiliary disorders | Salivary Gland Carcinoma | 1 | 25 | 1 |
| other | asparate aminotransferase (AST) increased | Hepatobiliary disorders | Head and Neck Squamous Cell Carcinoma | 0 | 25 | 0 |
| other | asparate aminotransferase (AST) increased | Hepatobiliary disorders | Salivary Gland Carcinoma | 1 | 25 | 1 |
| other | cough | Respiratory, thoracic and mediastinal disorders | Head and Neck Squamous Cell Carcinoma | 1 | 25 | 1 |
| other | cough | Respiratory, thoracic and mediastinal disorders | Salivary Gland Carcinoma | 0 | 25 | 0 |
| other | creatinine increased | Renal and urinary disorders | Head and Neck Squamous Cell Carcinoma | 2 | 25 | 2 |
| other | creatinine increased | Renal and urinary disorders | Salivary Gland Carcinoma | 5 | 25 | 6 |
| other | Fatigue | General disorders | Head and Neck Squamous Cell Carcinoma | 2 | 25 | 3 |
| other | Fatigue | General disorders | Salivary Gland Carcinoma | 4 | 25 | 6 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Head and Neck Squamous Cell Carcinoma | 22 | 25 |
| Total, all-cause mortality | Salivary Gland Carcinoma | 23 | 25 |
| Total, other adverse events | Head and Neck Squamous Cell Carcinoma | 11 | 25 |
| Total, other adverse events | Salivary Gland Carcinoma | 19 | 25 |
| Total, serious adverse events | Head and Neck Squamous Cell Carcinoma | 1 | 25 |
| Total, serious adverse events | Salivary Gland Carcinoma | 1 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | 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 |
|---|---|
| Head and Neck Squamous Cell Carcinoma vs Salivary Gland Carcinoma: deaths from any cause | Trial comparisons |
| Head and Neck Squamous Cell Carcinoma vs Salivary Gland Carcinoma: 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/NCT02538510
GET https://conductscience.org/api/trials/v1/NCT02538510/results?page=2