Trial Outcomes & Findings for Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma (NCT NCT02364076)
NCT ID: NCT02364076
Last Updated: 2019-12-13
Results Overview
To measure response of all the participants to the drug at the end of the study.
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
24 months
Results posted on
2019-12-13
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and Epacadostat
Pembrolizumab 200 mg intrvenoulsy every 3 weels
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab and Epacadostat
n=40 Participants
Pembrolizumab 200 mg intrvenoulsy every 3 weels
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsTo measure response of all the participants to the drug at the end of the study.
Outcome measures
| Measure |
Pembrolizumab
n=40 Participants
Pembrolizumab 200 mg intrvenoulsy every 3 weeks
|
|---|---|
|
Response Rate
Complete Response
|
1 Participants
|
|
Response Rate
Partial response
|
8 Participants
|
|
Response Rate
Stable Disease
|
21 Participants
|
|
Response Rate
Progression
|
10 Participants
|
SECONDARY outcome
Timeframe: 24 monthsTime between start of treatment and tumor progression or death
Outcome measures
| Measure |
Pembrolizumab
n=40 Participants
Pembrolizumab 200 mg intrvenoulsy every 3 weeks
|
|---|---|
|
Progression-free Survival
|
4.2 months
Interval 2.9 to 10.3
|
SECONDARY outcome
Timeframe: 24 monthsTime between start of treatment and death
Outcome measures
| Measure |
Pembrolizumab
n=40 Participants
Pembrolizumab 200 mg intrvenoulsy every 3 weeks
|
|---|---|
|
Overall Survival
|
24.9 months
Interval 15.5 to
Upper limit of the 95% confidence interval not reached
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Pembrolizumab
n=40 Participants
Pembrolizumab 200 mg intrvenoulsy every 3 weeks
|
|---|---|
|
Number of Participants With New-Onset Severe Adverse Events
|
6 Participants
|
Adverse Events
Pembrolizumab and Epacadostat
Serious events: 6 serious events
Other events: 40 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Pembrolizumab and Epacadostat
n=40 participants at risk
Pembrolizumab 200 mg intravenously every 3 weeks Epacadostat 100mg by mouth taken daily
Pembrolizumab: Administration of 200 mg MK-3475 once every 3 weeks
Epacadostat: 100mg taken by mouth twice daily
|
|---|---|
|
Immune system disorders
Bullous pemphigoid
|
2.5%
1/40 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Polymoyositis
|
2.5%
1/40 • 24 months
|
|
Hepatobiliary disorders
Hepatitis
|
2.5%
1/40 • 24 months
|
|
Cardiac disorders
Myocarditis
|
5.0%
2/40 • 24 months
|
|
Endocrine disorders
Hyperglycemia
|
2.5%
1/40 • 24 months
|
Other adverse events
| Measure |
Pembrolizumab and Epacadostat
n=40 participants at risk
Pembrolizumab 200 mg intravenously every 3 weeks Epacadostat 100mg by mouth taken daily
Pembrolizumab: Administration of 200 mg MK-3475 once every 3 weeks
Epacadostat: 100mg taken by mouth twice daily
|
|---|---|
|
General disorders
Fatigue
|
40.0%
16/40 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40 • 24 months
|
|
Endocrine disorders
hypothyroidism
|
12.5%
5/40 • 24 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
2.5%
1/40 • 24 months
|
|
Metabolism and nutrition disorders
Elevated alkaline phosphatase
|
25.0%
10/40 • 24 months
|
|
Cardiac disorders
myocarditis
|
5.0%
2/40 • 24 months
|
|
Metabolism and nutrition disorders
AST elevation
|
40.0%
16/40 • 24 months
|
|
General disorders
Flu like
|
5.0%
2/40 • 24 months
|
|
Hepatobiliary disorders
ALT increased
|
25.0%
10/40 • 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
22.5%
9/40 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthraglia
|
12.5%
5/40 • 24 months
|
|
General disorders
Fever
|
12.5%
5/40 • 24 months
|
|
Immune system disorders
Rhinitis
|
10.0%
4/40 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
4/40 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • 24 months
|
|
Immune system disorders
Rash
|
10.0%
4/40 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.5%
3/40 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Creatinine phosphokinase increased
|
7.5%
3/40 • 24 months
|
|
Hepatobiliary disorders
Bilirubin increased
|
5.0%
2/40 • 24 months
|
|
Eye disorders
Blurred vision
|
5.0%
2/40 • 24 months
|
|
Endocrine disorders
Dry mouth
|
5.0%
2/40 • 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
2/40 • 24 months
|
|
Endocrine disorders
Hyperurecemia
|
5.0%
2/40 • 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
2/40 • 24 months
|
|
Endocrine disorders
Amylase increased
|
2.5%
1/40 • 24 months
|
|
Endocrine disorders
Dehydration
|
2.5%
1/40 • 24 months
|
|
Endocrine disorders
Watering eyes
|
2.5%
1/40 • 24 months
|
|
Endocrine disorders
Hyperglycemia
|
2.5%
1/40 • 24 months
|
|
Blood and lymphatic system disorders
Leucocytopenia
|
2.5%
1/40 • 24 months
|
|
Endocrine disorders
Lipased increased
|
2.5%
1/40 • 24 months
|
|
Endocrine disorders
Facial swelling
|
2.5%
1/40 • 24 months
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • 24 months
|
|
Musculoskeletal and connective tissue disorders
skin disorders
|
2.5%
1/40 • 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • 24 months
|
Additional Information
Dr Giuseppe Giaccone
Georgetown University Medical Center -Lomabardi Comprehensive Cancer Center
Phone: 202-687-7072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place