Trial · NCT03126110
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
NCT03126110, Phase 1, Phase 2, Completed, Incyte Biosciences International Sàrl; results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies. Trials, record NCT03126110. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03126110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
- NCT number
- NCT03126110
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 145 participants, actual
- Lead sponsor
- Incyte Biosciences International Sàrl
- Conditions
- Advanced Malignancies, Metastatic Cancer
- Interventions
- INCAGN01876, Nivolumab, Ipilimumab
- First posted
- 2017-04-24
- Last updated
- 2025-08-14
- Other registries' IDs
- eudract:2016-004989-25
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 27.4 months | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication. |
| Primary | Phase 2: Objective Response Rate (ORR) Per RECIST v1.1 | up to approximately 44.7 months | ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR), determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. |
| Secondary | Phase 1: ORR Per RECIST v1.1 | up to approximately 44.7 months | ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. |
| Secondary | Phase 1: ORR Per Modified RECIST (mRECIST) v1.1 | up to approximately 44.7 months | ORR was defined as the percentage of participants with a best overall response of unconfirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. |
| Secondary | Phase 2: ORR Per mRECIST v1.1 | up to approximately 44.7 months | ORR was defined as the percentage of participants with a best overall response of confirmed CR or PR, determined by investigator assessment of radiographic disease assessments per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. |
| Secondary | Phase 1: Duration of Response (DOR) Per RECIST v1.1 | up to approximately 44.7 months | DOR was defined as the time from the first overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. |
| Secondary | Phase 2: DOR Per RECIST v1.1 | up to approximately 44.7 months | DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. |
| Secondary | Phase 1: DOR Per mRECIST v1.1 | up to approximately 44.7 months | DOR was defined as the time from the first unconfirmed overall response contributing to an unconfirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first confirmed assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. The response of target lesions was evaluated from the percentage change in the sum of the diameters of the viable portions (portions enhanced during the arterial phase). CR: Disappearance of any intratumoral arterial enhancement during in target lesions, disappearance of all non-target lesions, and no appearance of any new lesions. PR: ≥30% of the sum of the diameters of viable portions (enhancement on arterial phase) of target lesions taking as reference the Baseline sum, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. |
| Secondary | Phase 2: DOR Per mRECIST v1.1 | up to approximately 44.7 months | DOR was defined as the time from the first overall response contributing to a confirmed objective response (CR or PR) to the earlier of the participant's death from any cause or the first assessment of PD, determined by investigator assessment of radiographic disease assessment per mRECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. |
| Secondary | Phase 1: Disease Control Rate (DCR) Per RECIST v1.1 | up to approximately 44.7 months | DCR was defined as the percentage of participants with a best overall response of unconfirmed CR, unconfirmed PR, or stable disease (SD; ≥49 days), determined by investigator assessment of radiographic disease assessments per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 27.4 months | Phase 1 Full Analysis Set (FAS): all participants enrolled in Phase 1 of the study who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) Per RECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population: all participants enrolled in Phase 2 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: ORR Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population: all participants enrolled in Phase 1 who received at least 1 dose of INCAGN01876, nivolumab, or ipilimumab; completed a Baseline scan; and met at least 1 of the following criteria: (a) ≥1 post-Baseline scan (b) the participant has been in the study for a minimum of 64 days of follow-up; or (c) the participant had discontinued from treatment | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: ORR Per Modified RECIST (mRECIST) v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: ORR Per mRECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population | Percentage of Participants | NUMBER |
| SECONDARY | Phase 1: Duration of Response (DOR) Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Days | MEDIAN |
| SECONDARY | Phase 2: DOR Per RECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Days | MEDIAN |
| SECONDARY | Phase 1: DOR Per mRECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Days | MEDIAN |
| SECONDARY | Phase 2: DOR Per mRECIST v1.1 | up to approximately 44.7 months | Phase 2 Response Evaluable Population. Only those participants with a response of CR or PR were analyzed. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley. | Days | MEDIAN |
| SECONDARY | Phase 1: Disease Control Rate (DCR) Per RECIST v1.1 | up to approximately 44.7 months | Phase 1 Response Evaluable Population | Percentage of Participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group178
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 5 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 5 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 4 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 7 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 3 | Participants |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 results by groupParticipant flow102
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 | |
| Phase 1 | STARTED | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 | |
| Phase 1 | STARTED | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 5 | |
| Phase 1 | STARTED | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 | |
| Phase 1 | STARTED | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 5 | |
| Phase 1 | STARTED | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 | |
| Phase 1 | STARTED | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 | |
| Phase 1 | STARTED | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 4 | |
| Phase 1 | STARTED | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 8 | |
| Phase 1 | STARTED | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 3 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 participant flowAdverse events5,742
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 discomfort | Gastrointestinal disorders | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 0 | 5 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 0 | 5 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 0 | 4 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 1 | 8 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 0 | 3 | 0 |
1 to 10 of 5,742Source ClinicalTrials.gov
See all 5,742 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Group A: INCAGN01876 1.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 2 | 4 |
| Total, all-cause mortality | Phase 1 Group A: INCAGN01876 3.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 2 | 4 |
| Total, all-cause mortality | Phase 1 Group A: INCAGN01876 5.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 4 | 5 |
| Total, all-cause mortality | Phase 1 Group A: INCAGN01876 10.0 mg/kg Q2W + Nivolumab 240 mg Q2W | 3 | 4 |
| Total, all-cause mortality | Phase 1 Group B: INCAGN01876 1.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 | 5 |
| Total, all-cause mortality | Phase 1 Group B: INCAGN01876 3.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 4 | 4 |
| Total, all-cause mortality | Phase 1 Group B: INCAGN01876 5.0 mg/kg Q2W, Then Nivolumab 240 mg Q2W | 3 | 4 |
| Total, all-cause mortality | Phase 1 Group C: INCAGN01876 1.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 4 | 4 |
| Total, all-cause mortality | Phase 1 Group C: INCAGN01876 3.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 5 | 8 |
| Total, all-cause mortality | Phase 1 Group C: INCAGN01876 5.0 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W | 2 | 3 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers0
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.
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/NCT03126110
GET https://conductscience.org/api/trials/v1/NCT03126110/registered?page=2