Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT05083754
Phase
PHASE1
Status
Recruiting
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Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Retifanlimab — DRUG
    Anti-PD-1 Therapy
  • Temozolomide — DRUG
    Anti-PD-1 Therapy
  • Radiation Therapy — RADIATION
    Standard of Care

Study Details

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.

Key Dates

Start date
Aug 31, 2022
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A- Retifanlimab and Radiation Therapy
    Participants will receive Retifanlimab and Radiation Therapy.
  • Experimental: Arm B- Retifanlimab, Radiation Therapy and Temozolomide
    Participants will receive Retifanlimab, Radiation Therapy and Temozolomide.
  • Other: Arm C- Radiation Therapy and Temozolomide
    Participants will receive Radiation Therapy and Temozolomide which is the Standard of Care.

Primary Outcome Measure

Safety of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Medical InstitutionBaltimoreMaryland21287
Lawrence Kleinberg, MD
[email protected]
410-614-2597
Stella Krawiec, MA
[email protected]
410-502-1962

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By research site
Johns Hopkins Medical Institution· Baltimore, MD

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