Trial Outcomes & Findings for Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer (NCT NCT03196232)
NCT ID: NCT03196232
Last Updated: 2024-01-23
Results Overview
Progression-free survival (PFS) was assessed as the number of participants remaining alive without progression 6 months after beginning treatment. The outcome is reported as a number without dispersion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
6 months
Results posted on
2024-01-23
Participant Flow
Participant milestones
| Measure |
Treatment (Epacadostat, Pembrolizumab)
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 Participants
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 9.56 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProgression-free survival (PFS) was assessed as the number of participants remaining alive without progression 6 months after beginning treatment. The outcome is reported as a number without dispersion.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 Participants
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival (PFS)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Not all subjects completed 6 months of treatment.
Therapeutic response was assessed per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Criteria are: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the number of participants with a documented clinical response (ie, either PR or CR) at 6 months after initiation of treatment.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=1 Participants
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Response Rate
Complete Response (CR)
|
0 Participants
|
|
Response Rate
Partial Response (PR)
|
0 Participants
|
|
Response Rate
Overall Response (OR)
|
0 Participants
|
|
Response Rate
Progressive disease (PD)
|
1 Participants
|
|
Response Rate
Stable disease (SD)
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOverall survival (OS) was assessed as the number of participants remaining alive 6 months after beginning treatment. The outcome is reported as a number without dispersion.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 Participants
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsParticipants were monitored for adverse events. The outcome is reported as the overall number of adverse events of any grade, a number without dispersion.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 Participants
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Number of Adverse Events
|
42 Adverse events
|
SECONDARY outcome
Timeframe: Up to 6 monthsAdverse events were assessed per the Common Terminology Criteria for Adverse Events v4.03. The outcome is reported as the number of adverse events ≥ Grade 3, a number without dispersion.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 Participants
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Number of Adverse Events ≥ Grade 3
|
2 Adverse events
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe assessment for clinical value of the treatment combination included treatment delays or reductions, a measure of how well the combination treatment was tolerated. The outcome is reported as the number of participants that experienced a treatment delay, or reduction in treatment dose level, a number without dispersion.
Outcome measures
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 Participants
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Treatment Delay or Reduction
|
0 Participants
|
Adverse Events
Treatment (Epacadostat, Pembrolizumab)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 participants at risk
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Jejunal perforation
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - disease progression
|
66.7%
2/3 • Number of events 2 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
Other adverse events
| Measure |
Treatment (Epacadostat, Pembrolizumab)
n=3 participants at risk
Participants receive oral epacadostat BID on Days 1 to 21 and pembrolizumab IV over 30 minutes on Day 1, with cycles repeating every 21 days for up to 24 months, in the absence of disease progression or unacceptable toxicity.
Epacadostat: Given PO
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 3 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
2/3 • Number of events 2 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Jejunal Perforation
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Weight Loss
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 2 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Metabolism and nutrition disorders
Cholesterol high
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Gastrointestinal disorders
Hypertriglyceridemia
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Nervous system disorders
Depressed level of consciousness
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Skin and subcutaneous tissue disorders
Hair Color Change
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • Adverse events reported through 30 days after treatment. Overall mortality was monitored though 6 months.
|
Additional Information
George A Fisher, Colleen Haas Chair in the School of Medicine
Stanford University
Phone: 650) 725-9057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place