Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

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ClinicalTrials.gov Identifier: NCT02364076

Recruitment Status : Unknown

Verified November 2018 by Georgetown University.
Recruitment status was: Active, not recruiting

First Posted : February 16, 2015

Results First Posted : December 13, 2019

Last Update Posted : December 13, 2019

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Sponsor:

Collaborators:

Merck Sharp & Dohme LLC

Incyte Corporation

Information provided by (Responsible Party):

Georgetown University

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Thymic Carcinoma Thymus Neoplasms Thymus Cancer
Interventions	Drug: Pembrolizumab Drug: Epacadostat
Enrollment	45

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Pembrolizumab and Epacadostat
Arm/Group Description	Pembrolizumab 200 mg intrvenoulsy e...
Arm/Group Description	Pembrolizumab 200 mg intrvenoulsy every 3 weels
Period Title: Overall Study
Started	45
Completed	40
Not Completed	5

Baseline Characteristics

Arm/Group Title		Pembrolizumab and Epacadostat
Arm/Group Description		Pembrolizumab 200 mg intrvenoulsy e...
Arm/Group Description		Pembrolizumab 200 mg intrvenoulsy every 3 weels
Overall Number of Baseline Participants		40
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Standard Deviation) Unit of measure: Years
	Number Analyzed	40 participants
		57 (2)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	40 participants
	Female	12 30.0%
	Male	28 70.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	40 participants
	American Indian or Alaska Native	0 0.0%
	Asian	4 10.0%
	Native Hawaiian or Other Pacific Islander	1 2.5%
	Black or African American	2 5.0%
	White	33 82.5%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Response Rate
Description	To measure response of all the participants to the drug at the end of ...
Description	To measure response of all the participants to the drug at the end of the study.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pembrolizumab
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy e...
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy every 3 weeks
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants Unit of Measure: Participants
Complete Response	1 2.5%
Partial response	8 20.0%
Stable Disease	21 52.5%
Progression	10 25.0%

2.Secondary Outcome


Title	Progression-free Survival
Description	Time between start of treatment and tumor progression or death
Description	Time between start of treatment and tumor progression or death
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pembrolizumab
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy e...
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy every 3 weeks
Overall Number of Participants Analyzed	40
Median (95% Confidence Interval) Unit of Measure: months
	4.2 (2.9 to 10.3)

3.Secondary Outcome


Title	Overall Survival
Description	Time between start of treatment and death
Description	Time between start of treatment and death
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pembrolizumab
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy e...
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy every 3 weeks
Overall Number of Participants Analyzed	40
Median (95% Confidence Interval) Unit of Measure: months
	24.9 ^[1] (15.5 to NA)

[1]

Upper limit of the 95% confidence interval not reached

4.Secondary Outcome


Title	Number of Participants With New-Onset Severe Adverse Events
Description	[Not Specified]
Description	[Not Specified]
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Pembrolizumab
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy e...
Arm/Group Description:	Pembrolizumab 200 mg intrvenoulsy every 3 weeks
Overall Number of Participants Analyzed	40
Measure Type: Count of Participants Unit of Measure: Participants
	6 15.0%

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Pembrolizumab and Epacadostat
Arm/Group Description	Pembrolizumab 200 mg intravenously ...
Arm/Group Description	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
All-Cause Mortality
	Pembrolizumab and Epacadostat
	Affected / at Risk (%)
Total	17/40 (42.50%)
Serious Adverse Events Serious Adverse Events
	Pembrolizumab and Epacadostat
	Affected / at Risk (%)
Total	6/40 (15.00%)
Cardiac disorders
Myocarditis ^†	2/40 (5.00%)
Endocrine disorders
Hyperglycemia ^†	1/40 (2.50%)
Hepatobiliary disorders
Hepatitis ^†	1/40 (2.50%)
Immune system disorders
Bullous pemphigoid ^†	1/40 (2.50%)
Musculoskeletal and connective tissue disorders
Polymoyositis ^†	1/40 (2.50%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Pembrolizumab and Epacadostat
	Affected / at Risk (%)
Total	40/40 (100.00%)
Blood and lymphatic system disorders
Anemia ^†	4/40 (10.00%)
Neutropenia ^†	2/40 (5.00%)
Leucocytopenia ^†	1/40 (2.50%)
Thrombocytopenia ^†	1/40 (2.50%)
Cardiac disorders
myocarditis ^†	2/40 (5.00%)
Palpitations ^†	1/40 (2.50%)
Endocrine disorders
hypothyroidism ^†	5/40 (12.50%)
Dry mouth ^†	2/40 (5.00%)
Hyperthyroidism ^†	2/40 (5.00%)
Hyperurecemia ^†	2/40 (5.00%)
Amylase increased ^†	1/40 (2.50%)
Dehydration ^†	1/40 (2.50%)
Watering eyes ^†	1/40 (2.50%)
Hyperglycemia ^†	1/40 (2.50%)
Lipased increased ^†	1/40 (2.50%)
Facial swelling ^†	1/40 (2.50%)
Eye disorders
Blurred vision ^†	2/40 (5.00%)
Gastrointestinal disorders
Diarrhoea ^†	9/40 (22.50%)
Nausea ^†	4/40 (10.00%)
General disorders
Fatigue ^†	16/40 (40.00%)
Flu like ^†	2/40 (5.00%)
Fever ^†	5/40 (12.50%)
Hepatobiliary disorders
ALT increased ^†	10/40 (25.00%)
Bilirubin increased ^†	2/40 (5.00%)
Immune system disorders
Rhinitis ^†	4/40 (10.00%)
Rash ^†	4/40 (10.00%)
Metabolism and nutrition disorders
hypokalemia ^†	1/40 (2.50%)
Elevated alkaline phosphatase ^†	10/40 (25.00%)
AST elevation ^†	16/40 (40.00%)
Musculoskeletal and connective tissue disorders
Arthraglia ^†	5/40 (12.50%)
Myositis ^†	3/40 (7.50%)
Creatinine phosphokinase increased ^†	3/40 (7.50%)
skin disorders ^†	1/40 (2.50%)
Respiratory, thoracic and mediastinal disorders
Dyspnea ^†	3/40 (7.50%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr Giuseppe Giaccone
Organization:	Georgetown University Medical Center -Lomabardi Comprehensive Cancer Center
Phone:	202-687-7072
EMail:	gg496@georgetown.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

He Y, Ramesh A, Gusev Y, Bhuvaneshwar K, Giaccone G. Molecular predictors of response to pembrolizumab in thymic carcinoma. Cell Rep Med. 2021 Sep 3;2(9):100392. doi: 10.1016/j.xcrm.2021.100392. eCollection 2021 Sep 21.

Giaccone G, Kim C, Thompson J, McGuire C, Kallakury B, Chahine JJ, Manning M, Mogg R, Blumenschein WM, Tan MT, Subramaniam DS, Liu SV, Kaplan IM, McCutcheon JN. Pembrolizumab in patients with thymic carcinoma: a single-arm, single-centre, phase 2 study. Lancet Oncol. 2018 Mar;19(3):347-355. doi: 10.1016/S1470-2045(18)30062-7. Epub 2018 Jan 26.

Layout table for additonal information

Responsible Party:	Georgetown University
ClinicalTrials.gov Identifier:	NCT02364076
Other Study ID Numbers:	2014-1315
First Submitted:	February 10, 2015
First Posted:	February 16, 2015
Results First Submitted:	August 6, 2019
Results First Posted:	December 13, 2019
Last Update Posted:	December 13, 2019

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