NCT02178722 · OUTCOME
Phase 2: Ordinal Categorical Response Score
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers · Source last updated 2022-02-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 54 months
What was measured
Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups: 1 = Complete response per irRECIST v1.1 2 = Very good response, defined as \> 60% tumor reduction 3 = Minor response, defined as \> 30% to ≤ 60% tumor reduction 4 = Stable disease per irRECIST v1.1 5 = Progressive disease per irRECIST v1.1
Analysis population: The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.
Groups in this outcome
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 382 |
|---|
Reported measurements
Hepatocellular Carcinoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 24 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Triple Negative Breast Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 36 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Immune Checkpoint-naïve Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 43 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Primary Refractory Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Relapsed Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 36 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
NSCLC
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 58 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Renal Cell Carcinoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 37 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Squamous Cell Carcinoma of the Head and Neck
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 36 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Transitional Cell Carcinoma of the GU Tract
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 36 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Ovarian Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 37 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Gastric Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 27 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
MSI high Colorectal Cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 16 |
|---|
Complete Response - Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Very Good Response - Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Minor Response - Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease - Score 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease - Score 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Unable to Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Hepatocellular Carcinoma
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Triple Negative Breast Cancer
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Immune Checkpoint-naïve Melanoma
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Primary Refractory Melanoma
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Relapsed Melanoma
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- NSCLC
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Renal Cell Carcinoma
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Squamous Cell Carcinoma of the Head and Neck
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Transitional Cell Carcinoma of the GU Tract
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Ovarian Cancer
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- Gastric Cancer
- categories
- title
- Complete Response - Score 1
- title
- Very Good Response - Score 2
- title
- Minor Response - Score 3
- title
- Stable Disease - Score 4
- title
- Progressive Disease - Score 5
- title
- Unable to Evaluable
- title
- MSI high Colorectal Cancer
- description
- Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups: 1 = Complete response per irRECIST v1.1 2 = Very good response, defined as \> 60% tumor reduction 3 = Minor response, defined as \> 30% to ≤ 60% tumor reduction 4 = Stable disease per irRECIST v1.1 5 = Progressive disease per irRECIST v1.1
- groups
- description
- Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
- id
- OG000
- title
- Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.
- reporting Status
- POSTED
- time Frame
- Up to 54 months
- title
- Phase 2: Ordinal Categorical Response Score
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle