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Carmustine + Retifanlimab + Radiation for Glioblastoma

Phase 1
Recruiting
Led By Lawrence Kleinberg, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Karnofsky Performance Status of ≥ 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying how well carmustine wafers and radiation with or without temozolomide work in treating patients with newly diagnosed glioblastoma multiforme.

Who is the study for?
Adults over 18 with newly-diagnosed Grade IV Glioblastoma who've had carmustine wafers placed during surgery. They haven't had other GBM treatments, can sign consent, and are on stable or decreasing steroids. Women must not be pregnant or nursing, and men must use effective contraception. Participants need normal organ/marrow function, a Karnofsky Performance Status of ≥60, and no prior malignancies within 3 years (with some exceptions).Check my eligibility
What is being tested?
The trial is testing the combination of carmustine wafers with radiation therapy and retifanlimab immunotherapy, with or without temozolomide chemotherapy in adults after surgical placement of carmustine for glioblastoma treatment. The goal is to assess safety and survival outcomes.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site from retifanlimab, fatigue from radiation therapy or chemotherapy, digestive issues like nausea from temozolomide, blood disorders such as low white cell counts increasing infection risk, and potential liver or kidney function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
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My organ and bone marrow functions are normal.
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I have a new diagnosis of Grade IV brain cancer and had treatment with carmustine wafers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events
Maximum Tolerated Dose (MTD) as determined by number of participants with dose limiting toxicities (DLT)
Safety of combination retifanlimab and radiation with and without temozolomide as assessed by number of participants who experience adverse events
Secondary outcome measures
Overall Response Rate
Overall Survival
Progression Free Survival
+1 more
Other outcome measures
B cell count
Biomarker assessment in tumor and blood samples
CD4 cell count
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C- Radiation Therapy and TemozolomideExperimental Treatment2 Interventions
Participants will receive Radiation Therapy and Temozolomide which is the Standard of Care.
Group II: Arm B- Retifanlimab, Radiation Therapy and TemozolomideExperimental Treatment3 Interventions
Participants will receive Retifanlimab, Radiation Therapy and Temozolomide.
Group III: Arm A- Retifanlimab and Radiation TherapyExperimental Treatment2 Interventions
Participants will receive Retifanlimab and Radiation Therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Retifanlimab
2018
Completed Phase 2
~320
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
362 Previous Clinical Trials
55,033 Total Patients Enrolled
5 Trials studying Glioblastoma
492 Patients Enrolled for Glioblastoma
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,830 Total Patients Enrolled
31 Trials studying Glioblastoma
933 Patients Enrolled for Glioblastoma
Lawrence Kleinberg, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
40 Total Patients Enrolled
2 Trials studying Glioblastoma
19 Patients Enrolled for Glioblastoma

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05083754 — Phase 1
Glioblastoma Research Study Groups: Arm A- Retifanlimab and Radiation Therapy, Arm B- Retifanlimab, Radiation Therapy and Temozolomide, Arm C- Radiation Therapy and Temozolomide
Glioblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT05083754 — Phase 1
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05083754 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this medical trial been undertaken before?

"The development of Temozolomide began in 2002 with a trial supported by Schering-Plough. After the initial 60 patients, it was approved to enter Phase 2 and now there are 231 live trials occurring across 956 cities within 50 nations."

Answered by AI

What purpose is Temozolomide typically used to address?

"Temozolomide is often prescribed for nitrosourea treatment. It can also assist individuals with refractory advanced mycosis fungoides, advance directives and those suffering from refractory neuroblastoma."

Answered by AI

Could you outline the other experiments that have included Temozolomide?

"Presently, 231 trials revolving around Temozolomide are active with 26 of them in their third phase. With the majority situated in Seoul Songpa, there are still 5560 sites conducting research on this particular drug."

Answered by AI

Has Temozolomide been granted authorization by the FDA?

"The safety of Temozolomide is appraised at 1 due to being a Phase 1 trial, meaning that there is limited evidence for its efficacy and security."

Answered by AI

Are there still vacancies in this experiment that participants can join?

"This medical trial, which debuted on October 14th 2022, is still looking for participants. As indicated per its most recent update on September 26th 2022, it continues to accept recruits."

Answered by AI

Does this clinical investigation accommodate persons aged 55 and up?

"The ages of 18 to 100 are permissible for enrollment in this trial. For individuals younger than 18, 80 trials exist while 611 studies accommodate those 65 and over."

Answered by AI

What is the participant count for this research endeavor?

"Affirmative. The clinicaltrials.gov website states that this trial is currently enrolling individuals, with the initial posting taking place on October 14th 2022 and a subsequent update occurring on September 26th 2022. 50 volunteers are being sought at 1 medical facility to participate in the study."

Answered by AI

What are the desired results of this research endeavor?

"This trial, which is set to last up to two years, will assess the feasibility of a combination therapy involving retifanlimab and radiation (with or without temozolomide) by noting any adverse events that occur. Secondary objectives include evaluating progression-free survival levels after carmustine placement in patients receiving refitanlimab with/without temozolomide; establishing safety by counting treatment-emergent side effects on CTCAE v 5.0; examining overall response rate based on RECIST criteria measurements at baseline and post 2 doses of nivolumab plus ipilimumab."

Answered by AI

For whom is this trial open?

"This research project is seeking 50 individuals, aged between 18 and 100 years old, who have recently been diagnosed with glioblastoma. Furthermore, no prior treatment can have taken place other than surgery plus carmustine wafer placement (biopsy allowed). Participants must also be in good health post-surgery and not pregnant or breastfeeding. Contraception use should comply with current regulations."

Answered by AI
~26 spots leftby Jan 2026