Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05345002 · ClinicalTrials.gov registry record · Phase 2
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
A Phase 2 study of Glioma and Astrocytoma, sponsored by Stephen Bagley, MD, MSCE.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT05345002: Recruiting Phase 2 study of Glioma and Astrocytoma, sponsored by Stephen Bagley, MD, MSCE.
NCT05345002 is a Phase 2 study of Glioma and Astrocytoma that is actively recruiting participants, run by Stephen Bagley, MD, MSCE. The registered enrollment target is 55 participants, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05345002, a Phase 2 study of Glioma and Astrocytoma, is actively recruiting participants, sponsored by Stephen Bagley, MD, MSCE.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II study of the combination of All-Trans Retinonic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patient with recurrent IDH-mutant glioma. The Sponsor-Investigator hypothesizes that the proposed regimen will be safe and stimulate a robust anti-tumor immune response.
Primary Outcome
Objective radiographic response (ORR), as measured by modified Response Assessment in Neuro-Oncology (RANO) criteria. ). The response is classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).
Conditions Studied
Interventions
- DRUG Retifanlimab
- DRUG All-trans retinoic acid
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2022-11-16 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 2 |
What NCT05345002 shows while recruiting
NCT05345002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Glioma appearing as the primary indexed condition, and to 2 interventions - of which Retifanlimab is the first listed.
NCT05345002 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05345002 about?
NCT05345002 is a clinical study titled "All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma". This is a Phase II study of the combination of All-Trans Retinonic Acid (ATRA) and PD-1 inhibition (Retifanlimab) in patient with recurrent IDH-mutant glioma. The Sponsor-Investigator hypothesizes that the proposed regimen will be safe and stimulate a robust anti-tumor immune response.
What is the current status of trial NCT05345002?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2022-11-16. Estimated completion is 2028-06-01.
What conditions does trial NCT05345002 study?
This clinical trial studies the following conditions: Glioma, Astrocytoma, Oligodendroglioma, IDH Mutation.
What interventions are being tested in trial NCT05345002?
The interventions under investigation include: Retifanlimab (DRUG), All-trans retinoic acid (DRUG).
Who is sponsoring clinical trial NCT05345002?
This trial is sponsored by Stephen Bagley, MD, MSCE, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05345002 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 Glioma
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 NCT05345002's enrollment target sits among peer trials
55 34th of 87 higher than 52 of 87 other Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma 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
-
Pembrolizumab, Olaparib, and Temozolomide for People With Glioma
RECRUITING · Phase 2
-
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
RECRUITING · Phase 2
-
Methimazole in Patients With Progressive Glioblastoma
RECRUITING · Phase 2
-
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
RECRUITING · Phase 2
-
A Study Utilizing Escitalopram in Glioma Patients
RECRUITING · Phase 2
-
Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01638676 · 55 participants · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
- NCT03007030 · 55 participants · Phase 2
Brentuximab Vedotin in Treating Patients With CD30+ Malignant Mesothelioma That Cannot Be Removed by Surgery
- NCT03152058 · 55 participants · Phase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
- NCT03317158 · 55 participants · Phase 1
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI