Actively Recruiting
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-01-09
50
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety and survival of carmustine wafers and radiation and retifanlimab with or without temozolomide (TMZ) in newly-diagnosed adult subjects with glioblastoma multiform after carmustine wafer placement.
CONDITIONS
Official Title
Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with newly diagnosed WHO Grade IV glioblastoma or gliosarcoma confirmed by pathology or molecular testing who had carmustine wafers placed during surgery
- No prior treatment for glioblastoma other than surgery and carmustine wafer placement (prior biopsy allowed)
- Post-operative MRI or CT scan done within 72 hours (preferably 24 hours) after surgery
- Substantial recovery from surgery
- Stable or decreasing steroid dose
- Karnofsky Performance Status of 60 or higher
- Suitable for combined temozolomide and radiation therapy based on local guidelines
- Women who are not pregnant or lactating and meet contraceptive requirements
- Men agree to use birth control to avoid fathering children from screening until 180 days after last retifanlimab dose
- Normal organ and bone marrow function based on routine lab tests
- Able to understand and willing to sign informed consent
- Willing and able to follow scheduled visits, treatments, and study procedures
You will not qualify if you...
- Recurrent glioblastoma or progression from a lower grade tumor
- Central nervous system hemorrhage greater than Grade 1 on baseline MRI unless resolved
- Known metastatic disease outside the brain or leptomeningeal disease
- Plan to use other anti-cancer treatments including the Optune device
- Serious or uncontrolled medical conditions that increase risk or interfere with treatment
- Prior treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4, or similar
- Active autoimmune disease except certain controlled conditions (type I diabetes, hypothyroidism, mild skin disorders)
- History of life-threatening reaction to prior immunoglobulin or study drugs without approval
- Other central nervous system disorders unrelated to cancer unless controlled
- Surgery less than 7 days before study treatment (except central venous access device insertion)
- Inability to swallow oral medication or gastrointestinal conditions affecting temozolomide absorption
- Prior malignancy within 3 years except certain cured cancers
- Positive tests for hepatitis B, hepatitis C, or HIV/AIDS
- Interstitial lung disease or active noninfectious pneumonitis
- Recent palliative radiation or high-dose thoracic radiation with unresolved toxicity
- Unrecovered toxicity from prior therapy except alopecia or mild anemia
- Abnormal laboratory values at screening
- Active autoimmune disease requiring high-dose immunosuppression
- Active infection needing systemic antibiotics or antifungal treatment
- History of organ transplant
- Allergy to retifanlimab or its components
- Live vaccine received within 28 days before study drug start
- Taking probiotic dietary supplements
- Uncontrolled illness or psychiatric/social issues limiting study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Medical Institution
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
L
Lawrence Kleinberg, MD
CONTACT
I
Ipshita Faldu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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