Trial Outcomes & Findings for 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 NCT02538510)
NCT ID: NCT02538510
Last Updated: 2024-11-26
Results Overview
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 30 days after the completion of study treatment
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
Head and Neck Squamous Cell Carcinoma
MK-3475 combined with vorinostat,HNSCC patients
|
Salivary Gland Carcinoma
MK-3475 combined with votinostat, SGC patients
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Head and Neck Squamous Cell Carcinoma
n=25 Participants
Head and Neck Squamous Cell Carcinoma patients
|
Salivary Gland Carcinoma
n=25 Participants
Salivary Gland Carcinoma patients
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Continuous
|
63.12 years
STANDARD_DEVIATION 8.99 • n=99 Participants
|
56.84 years
STANDARD_DEVIATION 13.64 • n=107 Participants
|
59.98 years
STANDARD_DEVIATION 11.91 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after the completion of study treatmentPopulation: Only G3 toxicities and toxicities requiring dose hold/reduction recorded.
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Head and Neck Squamous Cell Carcinoma
n=25 Participants
AEs experienced with MK-3475 combined with vorinostat in HNSCC patients
|
Salivary Gland Carcinoma
n=25 Participants
AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients
|
|---|---|---|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Adrenal insufficiency
|
1 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
ALT increase
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anorexia
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Arthiritis
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
AST increase
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Cough
|
1 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Increased Creatinine
|
2 Participants
|
5 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Dermatitis
|
1 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Diarrhea
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fever with leukocytosis
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Fatigue
|
2 Participants
|
4 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hyponatremia
|
2 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Hypothyroidism
|
1 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Colitis and Ileitis
|
1 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Malaise
|
1 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nausea
|
1 Participants
|
3 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Nephritis
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Pneumonitis
|
1 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neuritis
|
0 Participants
|
1 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Tracheitis/Epiglottitis
|
1 Participants
|
0 Participants
|
|
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Vomiting
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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)
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.
Outcome measures
| Measure |
Head and Neck Squamous Cell Carcinoma
n=21 Participants
AEs experienced with MK-3475 combined with vorinostat in HNSCC patients
|
Salivary Gland Carcinoma
n=23 Participants
AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients
|
|---|---|---|
|
Objective Response Rate
partial response
|
8 Participants
|
4 Participants
|
|
Objective Response Rate
stable disease
|
8 Participants
|
13 Participants
|
|
Objective Response Rate
progressive disease
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 7 years 6 monthsThe Kaplan Meier methods will be used to estimate overall survival.
Outcome measures
| Measure |
Head and Neck Squamous Cell Carcinoma
n=25 Participants
AEs experienced with MK-3475 combined with vorinostat in HNSCC patients
|
Salivary Gland Carcinoma
n=25 Participants
AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients
|
|---|---|---|
|
Overall Survival
|
23.2 Months
Interval 12.9 to 33.5
|
28.04 Months
Interval 17.8 to 38.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe Kaplan Meier methods will be used to estimate progression free survival.
Outcome measures
| Measure |
Head and Neck Squamous Cell Carcinoma
n=25 Participants
AEs experienced with MK-3475 combined with vorinostat in HNSCC patients
|
Salivary Gland Carcinoma
n=25 Participants
AEs experienced with MK-3475 combined with vorinostat in salivary gland carcinoma patients
|
|---|---|---|
|
Progression Free Survival
|
12.6 Months
Interval 8.1 to 15.3
|
14.0 Months
Interval 8.5 to 24.5
|
Adverse Events
Head and Neck Squamous Cell Carcinoma
Serious events: 1 serious events
Other events: 11 other events
Deaths: 22 deaths
Salivary Gland Carcinoma
Serious events: 1 serious events
Other events: 19 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Head and Neck Squamous Cell Carcinoma
n=25 participants at risk
MK-3475 combined with vorinostat in HNSCC patients
|
Salivary Gland Carcinoma
n=25 participants at risk
MK-3475 combined with vorinostat in SGC patients
|
|---|---|---|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/25 • 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.
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.
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
0.00%
0/25 • 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.
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.
|
Other adverse events
| Measure |
Head and Neck Squamous Cell Carcinoma
n=25 participants at risk
MK-3475 combined with vorinostat in HNSCC patients
|
Salivary Gland Carcinoma
n=25 participants at risk
MK-3475 combined with vorinostat in SGC patients
|
|---|---|---|
|
Hepatobiliary disorders
alanine amintotransferase (ALT) increased
|
0.00%
0/25 • 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.
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.
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
|
Hepatobiliary disorders
asparate aminotransferase (AST) increased
|
0.00%
0/25 • 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.
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.
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
0.00%
0/25 • 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.
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.
|
|
Renal and urinary disorders
creatinine increased
|
8.0%
2/25 • Number of events 2 • 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.
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.
|
20.0%
5/25 • Number of events 6 • 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.
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.
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 3 • 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.
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.
|
16.0%
4/25 • Number of events 6 • 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.
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.
|
|
Infections and infestations
Fever with Leukocytosis
|
0.00%
0/25 • 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.
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.
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
2/25 • Number of events 2 • 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.
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.
|
0.00%
0/25 • 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.
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.
|
|
General disorders
Malaise
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
0.00%
0/25 • 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.
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.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
12.0%
3/25 • Number of events 4 • 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.
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.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
8.0%
2/25 • Number of events 2 • 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.
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.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/25 • 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.
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.
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
|
Immune system disorders
Adrenal insufficiency
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
4.0%
1/25 • Number of events 1 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place