Clinical trial · Interventional
INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
NCT03277352CI-TRIAL-00052831terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to emergent data from another study and unrelated to safety.
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epacadostat | Drug | — | UNRESOLVED |
| INCAGN01876 | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- INCAGN01876 + Pembrolizumab + Epacadostat
- description
- INCAGN01876 in combination with pembrolizumab and epacadostat
- interventionNames
- Drug: INCAGN01876
- Drug: Epacadostat
- Drug: Pembrolizumab
Primary outcomes (3)
- measure
- Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
- timeFrame
- Screening through 60 days after end of treatment, up to approximately 18 months
- description
- 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.
- measure
- Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Phase 1: Subjects with advanced or metastatic solid tumors. * Phase 1: Subjects who have disease progression after treatment with available therapies. * Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma. * Presence of measurable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group performance status of 0 or 1. Exclusion Criteria: * Laboratory and medical history parameters not within the Protocol-defined range * Prior treatment with any tumor necrosis factor super family agonist. * Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy. * Active autoimmune disease. * Known active central nervous system metastases and/or carcinomatous meningitis. * Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. * Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
References
Publications (0)
Data not yet available
No reference posted for this study.