Actively Recruiting
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
Led by Stephen Bagley, MD, MSCE · Updated on 2026-02-20
55
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
Sponsors
S
Stephen Bagley, MD, MSCE
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior diagnosis of astrocytoma (grade 2-4) or oligodendroglioma (grade 2-3) with progression or recurrence after at least one alkylating chemotherapy
- Tumor confirmed to have mutation in IDH1 or IDH2 by DNA sequencing
- Measurable disease by MRI for Safety Run-In and Phase 2 patients; surgical patients must be eligible for tumor resection
- Failed temozolomide or another alkylator for Safety Run-In; Arm A must have failed temozolomide and another alkylator; Arm B must have failed one prior alkylator and be at least 12 months since last treatment
- Able to undergo brain MRI with gadolinium and maintain stable or decreased corticosteroid dose before baseline MRI
- Recovered from prior treatment toxicities for specified intervals
- If on corticosteroids for brain edema, dose must be 2 mg dexamethasone daily or less for at least 5 days before first retifanlimab dose
- Able to swallow oral medications
- Age 18 years or older
- Karnofsky performance status ≥ 60
- Life expectancy greater than 3 months
- Adequate organ and marrow function including specific lab thresholds
- Women of childbearing potential must have negative pregnancy test and agree to pregnancy prevention measures; males must agree to contraception if sexually active with such women
- Able to comply with study procedures and provide informed consent
You will not qualify if you...
- Contrast-enhancing tumor in brainstem or spinal cord
- Diffuse leptomeningeal disease
- Received bevacizumab within last 3 months
- Clinically significant brain mass effect or midline shift
- Use of immunosuppressive medications other than steroids within 6 months
- Prior diagnosis of immunodeficiency
- Prior solid organ or bone marrow transplant
- Active autoimmune disease requiring systemic immunosuppression above physiologic doses
- Interstitial lung disease, active pneumonitis, or history thereof
- Prior severe immune-related toxicity from checkpoint inhibitors requiring discontinuation
- Active hepatitis B or C infection
- HIV-positive on antiretroviral therapy
- Prior or concurrent malignancy interfering with study assessments
- Serious uncontrolled medical disorders or infections
- Significant cardiovascular disease including recent myocardial infarction or severe heart failure
- Known hypersensitivity or allergy to retifanlimab, ATRA, or monoclonal antibodies
- Prisoners or involuntarily detained individuals
- Pregnant women
- Received live vaccines within 28 days before study start
- Current enrollment in other interventional clinical trials
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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