TriangleNCT02538510 · STUDY IN CONTEXT
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: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
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.
The Kaplan Meier methods will be used to estimate overall survival.
The Kaplan Meier methods will be used to estimate progression free survival.
Reported safety
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-salivary-gland-cancer
- 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
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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-salivary-gland-cancer
- 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