Trial · NCT03277352
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
NCT03277352, Phase 1, Phase 2, Terminated, Incyte Biosciences International Sàrl; results first posted 2021-07-22
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies. Trials, record NCT03277352. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03277352
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
- NCT number
- NCT03277352
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Incyte Biosciences International Sàrl
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Interventions
- INCAGN01876, Epacadostat, Pembrolizumab
- First posted
- 2017-09-11
- Last updated
- 2021-07-22
- Results first posted
- 2021-07-22
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 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Screening through 60 days after end of treatment, up to approximately 18 months | A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment. |
| Primary | Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1. |
| Primary | Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1 | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1 |
| Secondary | Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months. | Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1. |
| Secondary | Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause. |
| Secondary | Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | Defined as time from first report of SD or better until disease progression or death from any cause. |
| Secondary | Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause. |
| Secondary | Phase 1 & Phase 2: Overall Survival | At 1 year and 2 years. | Defined as the time from the start of combination therapy until death due to any cause. |
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 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | Screening through 60 days after end of treatment, up to approximately 18 months | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1 | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | The study was terminated early and no participants enrolled in Phase 2 of the study. | ||
| SECONDARY | Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | days | MEDIAN |
| SECONDARY | Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | days | MEDIAN |
| SECONDARY | Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST | Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | months | MEDIAN |
| SECONDARY | Phase 1 & Phase 2: Overall Survival | At 1 year and 2 years. | The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | INCAGN01876 + Pembrolizumab + Epacadostat | 10 | Participants | ||
| Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST | INCAGN01876 + Pembrolizumab + Epacadostat | 3 | Participants | ||
| Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST | INCAGN01876 + Pembrolizumab + Epacadostat | 7 | Participants | ||
| Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST | INCAGN01876 + Pembrolizumab + Epacadostat | NA | 95% Confidence Interval 273 to NA | days | |
| Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST | INCAGN01876 + Pembrolizumab + Epacadostat | mRECIST | NA | 95% Confidence Interval 525 to NA | days |
| Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST | INCAGN01876 + Pembrolizumab + Epacadostat | RECIST | 525 | 95% Confidence Interval 92 to NA | days |
| Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST | INCAGN01876 + Pembrolizumab + Epacadostat | mRECIST | 17.36 | 95% Confidence Interval 2.05 to NA | months |
| Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST | INCAGN01876 + Pembrolizumab + Epacadostat | RECIST | 4.20 | 95% Confidence Interval 0.73 to NA | months |
| Phase 1 & Phase 2: Overall Survival | INCAGN01876 + Pembrolizumab + Epacadostat | 25.59 | 95% Confidence Interval 16.76 to NA | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | INCAGN01876 + Pembrolizumab + Epacadostat | 10 | |
| Overall Study | COMPLETED | INCAGN01876 + Pembrolizumab + Epacadostat | 0 | |
| Overall Study | NOT COMPLETED | INCAGN01876 + Pembrolizumab + Epacadostat | 10 |
Source ClinicalTrials.gov
Adverse events108
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 | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 1 | 10 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Total | 1 | 10 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 1 | 10 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Total | 1 | 10 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 1 | 10 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Total | 1 | 10 | 1 |
| other | Aphthous ulcer | Gastrointestinal disorders | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 1 | 10 | 1 |
| other | Aphthous ulcer | Gastrointestinal disorders | Total | 1 | 10 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 2 | 10 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Total | 2 | 10 | 2 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 4 | 10 |
| Total, all-cause mortality | Total | 4 | 10 |
| Total, other adverse events | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 10 | 10 |
| Total, other adverse events | Total | 10 | 10 |
| Total, serious adverse events | INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID | 3 | 10 |
| Total, serious adverse events | Total | 3 | 10 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID vs Total: deaths from any cause | Trial comparisons |
| INCAGN01876 300 mg Q3W + Pembrolizumab 200 mg Q3W + Epacadostat 100 mg BID vs Total: serious adverse events | Trial comparisons |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03277352
GET https://conductscience.org/api/trials/v1/NCT03277352/events?page=2