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

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0

Only G3 toxicities and toxicities requiring dose hold/reduction recorded.

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secondary · POSTED

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.

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)

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secondary · POSTED

The Kaplan Meier methods will be used to estimate overall survival.

Source null

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secondary · POSTED

The Kaplan Meier methods will be used to estimate progression free survival.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id: NCT02538510
trial label: 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
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0000
source section id
NCT02538510-om-0000
source outcome index
0
endpoint
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
endpoint definition
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
time origin
Up to 30 days after the completion of study treatment
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only G3 toxicities and toxicities requiring dose hold/reduction recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0001
source section id
NCT02538510-om-0001
source outcome index
1
endpoint
Objective Response Rate
endpoint definition
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.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0002
source section id
NCT02538510-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
The Kaplan Meier methods will be used to estimate overall survival.
time origin
Up to 7 years 6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0003
source section id
NCT02538510-om-0003
source outcome index
3
endpoint
Progression Free Survival
endpoint definition
The Kaplan Meier methods will be used to estimate progression free survival.
time origin
Up to 2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0000
arm key
OG000
arm label
Head and Neck Squamous Cell Carcinoma
regimen
AEs experienced with MK-3475 combined with vorinostat in HNSCC patients
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0000
arm key
OG001
arm label
Salivary Gland Carcinoma
regimen
AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0001
arm key
OG000
arm label
Head and Neck Squamous Cell
regimen
Head and Neck Squamous Cell RECIST 1.1
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0001
arm key
OG001
arm label
Salivary Gland Carcinoma
regimen
RECIST 1.1 response rate salivary gland
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0002
arm key
OG000
arm label
Head and Neck Squamous Cell Carcinoma
regimen
Head and Neck Squamous Cell Carcinoma Patients
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0002
arm key
OG001
arm label
Salivary Gland Carcinoma
regimen
Salivary Gland Carcinoma Patients
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0003
arm key
OG000
arm label
Head and Neck Squamous Cell Carcinoma
regimen
Head and Neck Squamous Cell Carcinoma patients
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
outcome key
om-0003
arm key
OG001
arm label
Salivary Gland Carcinoma
regimen
Salivary Gland Carcinoma patients
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02538510-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
harm key
EG000
source section id
NCT02538510-ae
event group key
EG000
event group label
Head and Neck Squamous Cell Carcinoma
serious affected
1
serious at risk
25
other affected
11
other at risk
25
frequency threshold
0
collection period
All-Cause Mortality was monitored for up to 7 years and 6 months; serious and/or other adverse events were assessed up to 3 years and 6 months.
event definition
Adverse events are collected from the first dose of Mk-3475 or Vorinostat, and are collected through 30 days post the last dose of therapy.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT02538510
harm key
EG001
source section id
NCT02538510-ae
event group key
EG001
event group label
Salivary Gland Carcinoma
serious affected
1
serious at risk
25
other affected
19
other at risk
25
frequency threshold
0
collection period
All-Cause Mortality was monitored for up to 7 years and 6 months; serious and/or other adverse events were assessed up to 3 years and 6 months.
event definition
Adverse events are collected from the first dose of Mk-3475 or Vorinostat, and are collected through 30 days post the last dose of therapy.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice