Trial · NCT03347123
A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)
NCT03347123, Phase 1, Phase 2, Terminated, Incyte Corporation; results first posted 2022-02-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208). Trials, record NCT03347123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03347123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)
- NCT number
- NCT03347123
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Solid Tumors
- Interventions
- Epacadostat, Nivolumab, Ipilimumab, Lirilumab
- First posted
- 2017-11-20
- Last updated
- 2022-02-28
- Other registries' IDs
- eudract:2017-001743-12
- Results first posted
- 2022-02-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs) | Screening through up to 100 days after end of treatment, up to approximately 24 months | A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. |
| Primary | Phase 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Phase 1: Objective Response Rate (ORR) Based on RECIST v1.1 | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Phase 1: Duration of Response (DOR) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. |
| Secondary | Phase 1: Progression-free Survival (PFS) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. |
| Secondary | Phase 2: Duration of Response (DOR) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. |
| Secondary | Phase 2: Progression-free Survival (PFS) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions. |
| Secondary | Phase 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Screening through up to 100 days for treatment Group A and 150 days for treatment Group B after end of treatment, up to approximately 24 months | A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs) | Screening through up to 100 days after end of treatment, up to approximately 24 months | Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy. Treatment group B was excluded from this analysis as no participants were enrolled. | percentage of participants | NUMBER |
| PRIMARY | Phase 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned. | ||
| SECONDARY | Phase 1: Objective Response Rate (ORR) Based on RECIST v1.1 | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned. | ||
| SECONDARY | Phase 1: Duration of Response (DOR) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned. | ||
| SECONDARY | Phase 1: Progression-free Survival (PFS) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned. | ||
| SECONDARY | Phase 2: Duration of Response (DOR) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned. | ||
| SECONDARY | Phase 2: Progression-free Survival (PFS) | Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24) | As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned. | ||
| SECONDARY | Phase 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | Screening through up to 100 days for treatment Group A and 150 days for treatment Group B after end of treatment, up to approximately 24 months | As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs) | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 100 | percentage of participants | ||
| Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs) | Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 100 | percentage of participants |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: Dose Escalataion: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 5 | |
| Overall Study | STARTED | Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 6 | |
| Overall Study | STARTED | Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID | 0 | |
| Overall Study | STARTED | Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID | 0 | |
| Overall Study | STARTED | Phase 2: Dose Expansion: Treatment Group A: Cohort A1 | 0 | |
| Overall Study | STARTED | Phase 2: Dose Expansion: Treatment Group A: Cohort A2 | 0 | |
| Overall Study | STARTED | Phase 2: Dose Expansion: Treatment Group B: Cohort B1 | 0 | |
| Overall Study | COMPLETED | Phase 1: Dose Escalataion: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 0 | |
| Overall Study | COMPLETED | Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 0 | |
| Overall Study | COMPLETED | Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events210
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 1 | 5 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Total | 1 | 11 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 0 | 5 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 1 | 6 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Total | 1 | 11 | 2 |
| other | Alanine aminotransferase increased | Investigations | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 1 | 5 | 1 |
| other | Alanine aminotransferase increased | Investigations | Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 0 | 6 | 0 |
| other | Alanine aminotransferase increased | Investigations | Total | 1 | 11 | 1 |
| other | Amylase increased | Investigations | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 0 | 5 | 0 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 1 | 5 |
| Total, all-cause mortality | Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 2 | 6 |
| Total, all-cause mortality | Total | 3 | 11 |
| Total, other adverse events | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 5 | 5 |
| Total, other adverse events | Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 6 | 6 |
| Total, other adverse events | Total | 11 | 11 |
| Total, serious adverse events | Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID | 2 | 5 |
| Total, serious adverse events | Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID | 3 | 6 |
| Total, serious adverse events | Total | 5 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03347123
GET https://conductscience.org/api/trials/v1/NCT03347123/flow?page=2