Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors (NCT NCT03361228)
NCT ID: NCT03361228
Last Updated: 2020-05-21
Results Overview
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to approximately 12 months per subject
Results posted on
2020-05-21
Participant Flow
The study was conducted at 3 different sites in US. A total of 10 patients were screened and 5 patients enrolled in study.
No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
Participant milestones
| Measure |
INCB001158 50mg BID+ Epacadostat + Pembrolizumab
INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
|
INCB001158 75 mg BID + Epacadostat + Pembrolizumab
INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
INCB001158 50mg BID+ Epacadostat + Pembrolizumab
INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
|
INCB001158 75 mg BID + Epacadostat + Pembrolizumab
INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
|
|---|---|---|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Death
|
3
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Up to approximately 12 months per subjectPopulation: No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to approximately 12 months per subjectPopulation: Data was not collected as no participants were enrolled in Phase 2 of the study
Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 12 months per subjectPopulation: Data was not collected as no participants were enrolled in Phase 2 of the study
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 12 months per subjectPopulation: No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 12 months per subjectPopulation: No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 12 months per subjectPopulation: No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 12 months per subjectPopulation: No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 1 monthPopulation: No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.
Outcome measures
Outcome data not reported
Adverse Events
INCB001158 50mg BID+ Epacadostat + Pembrolizumab
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
INCB001158 75 mg BID + Epacadostat + Pembrolizumab
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
INCB001158 50mg BID+ Epacadostat + Pembrolizumab
n=4 participants at risk
INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
|
INCB001158 75 mg BID + Epacadostat + Pembrolizumab
n=1 participants at risk
INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
INCB001158 50mg BID+ Epacadostat + Pembrolizumab
n=4 participants at risk
INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
|
INCB001158 75 mg BID + Epacadostat + Pembrolizumab
n=1 participants at risk
INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
|
|---|---|---|
|
Eye disorders
Dry eye
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
General disorders
Chills
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
50.0%
2/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
General disorders
Peripheral swelling
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Investigations
Weight increased
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to approximately 12 months
The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER