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Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Randomized, Open-label Pilot Trial to Evaluate the Safety and Efficacy of Carmustine Wafer in Combination With Retifanlimab and Standard Radiation With or Without Temozolomide in Newly-Diagnosed Adult Subjects With Glioblastoma

NCT05083754•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Newly-diagnosed adults with WHO (World Health Organization) Grade IV Glioblastoma or gliosarcoma based on histopathological or molecular criteria who had carmustine wafers placed at resection
•No prior treatment for GBM other than surgical resection and carmustine wafer placement (Patients who had a biopsy prior to resection are allowed)
•Post-operative MRI or CT scan within 72 hours (preferably 24 hours) of surgical resection
•Substantial recovery from surgical resection
•On a stable or decreasing dose of steroids
•Karnofsky Performance Status of ≥ 60
•Clinically appropriate for concomitant temozolomide plus radiation therapy (RT) based on institutional guidelines
•Age ≥18 years
•Ensure that pregnant or lactating females are not enrolled and that contraceptive requirements are in accordance with applicable and recent requirements.
•Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 180 days after the last dose of retifanlimab
+3 more criteria

Exclusion Criteria

•Recurrent glioblastoma (GBM) or progression of lower grade tumor
•Central nervous system (CNS) hemorrhage of Grade \> 1 on baseline MRI scan, unless subsequently documented to have resolved
•Any known metastatic extracranial or leptomeningeal disease
•Intent to use other anti-neoplastic medications/treatments including the Optune® device
•Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
•Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
•Active, known or suspected autoimmune disease, with the following exceptions: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment (subjects with a history of flares requiring systemic treatment are excluded), or other autoimmune conditions not expected to recur in the absence of an external trigger are permitted to enroll
•Subjects with history of life-threatening toxicity, including hypersensitivity reaction, related to prior immunoglobulin treatment for another condition (except those considered unlikely to re-occur, with written approval of study PI) or any other study drug component
•History or evidence upon physical/neurological examination of other central nervous system condition (e.g., seizures, abscess) unrelated to cancer, unless adequately controlled by medication or considered not potentially interfering with protocol treatment
•Surgical procedure \< 7 days prior to study treatment (No restriction for insertion of a central venous access device)
+20 more criteria

Locations (1)

Johns Hopkins Medical Institution

Baltimore, Maryland, United States

Key Dates

Start Date

August 31, 2022

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2029

Last Updated

January 9, 2026

Enrollment

ESTIMATED participants

Conditions

Glioblastoma Multiforme

Interventions

Retifanlimab

DRUG

Temozolomide

DRUG

Radiation Therapy

RADIATION

Contacts

Lawrence Kleinberg, MD

CONTACT

410-614-2597 kleinla@jhmi.edu

Ipshita Faldu

CONTACT

667-306-8336 ifaldu1@jhu.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Targeted Pediatric High-Grade Glioma Therapy

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