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NCT04056910 · ClinicalTrials.gov registry record · Phase 2
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
A Phase 2 study of Advanced Solid Tumor and Glioma, sponsored by Jason J. Luke, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04056910: Completed Phase 2 study of Advanced Solid Tumor and Glioma, sponsored by Jason J. Luke, MD.
NCT04056910 is a Phase 2 study of Advanced Solid Tumor and Glioma that has completed, run by Jason J. Luke, MD. The registered enrollment target is 15 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04056910, a Phase 2 study of Advanced Solid Tumor and Glioma, has completed, sponsored by Jason J. Luke, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, response to treatment and (progression free and overall) survival will be described and safety events of ivosidenib in combination with nivolumab will be summarized in patients with advanced solid tumors (nonresectable or metastatic) or enhancing gliomas.
Primary Outcome
Number of patients with Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm, Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters per RECIST v1.1 Criteria, or, per
Conditions Studied
Interventions
- DRUG ivosidenib and nivolumab
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2023-11-13 |
| Phase | Phase 2 |
What the finished NCT04056910 record still lists
NCT04056910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which ivosidenib and nivolumab is the first listed.
NCT04056910 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04056910 about?
NCT04056910 is a clinical study titled "Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors". In this study, response to treatment and (progression free and overall) survival will be described and safety events of ivosidenib in combination with nivolumab will be summarized in patients with advanced solid tumors (nonresectable or metastatic) or enhancing gliomas.
What is the current status of trial NCT04056910?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2021-09-20. Estimated completion is 2023-11-13.
What conditions does trial NCT04056910 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Glioma, IDH1 Mutation.
What interventions are being tested in trial NCT04056910?
The interventions under investigation include: ivosidenib and nivolumab (DRUG).
Who is sponsoring clinical trial NCT04056910?
This trial is sponsored by Jason J. Luke, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04056910 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04056910's enrollment target sits among peer trials
15 184th of 189 higher than 2 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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