All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Stephen Bagley, MD, MSCE
Study ID
NCT05345002
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Retifanlimab — DRUG
    Administered 500mg IV on day 1 of every 28-day cycle, continued until disease progression, unacceptable toxicity, or 2 years from the first dose of study medication, whichever occurs first.
  • All-trans retinoic acid — DRUG
    All-trans retinoic acid (ATRA) 45mg/m2 orally in two equally divided doses on days 1-14 of each 28-day cycle, continued until disease progression, unacceptable toxicity, or 2 years from the first dose of study medication, whichever occurs first.

Study Details

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.

Key Dates

Start date
Nov 16, 2022
Status verified
Feb 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (failed prior TMZ + one other alkylating chemotherapy)
    Subjects in Arm A are alkylator-refractory and at high risk for progression of disease, have failed temozolmide and another alkylating agent. Subjects in Arm A will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1 through 14 and retifanlimab 500mg IV on day 1.
  • Experimental: Arm B (failed only one prior alkylating chemotherapy)
    Subject in Arm B are patients who have failed only one prior alkylating chemotherapy regimen and have gone at least 12 months since the last treatment. Subjects in Arm B will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1 through 14 and retifanlimab 500mg IV on day 1.
  • Experimental: Arm C (surgical arm, ATRA alone pre-operatively)
    Subject in Arm C will receive ATRA 45mg/m2/day orally in two equally divided doses for 14 days pre-surgery, then undergo surgery. Following surgery all patients will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1-14 and retifanlimab 500mg IV on day 1.
  • Experimental: Arm D (surgical arm, ATRA + retifanlimab pre-operatively)
    Subject in Arm D will receive the combination of ATRA 45mg/m2/day orally in two equally divided doses for 14 days pre-surgery plus a 500mg IV dose of retifanlimab 14 days prior to the date of surgery. Following surgery all patients will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1-14 and retifanlimab 500mg IV on day 1.

Primary Outcome Measure

Objective radiographic response (ORR) [ Time Frame: 26 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Abramson Cancer Center ACC Clinical Trials Navigation
[email protected]
1-215-349-8245
Timothy Prior
[email protected]
Stephen Bagley, MD, MSCE (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Pennsylvania· Philadelphia, PA

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