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Carmustine + Retifanlimab + Radiation for Glioblastoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I had a brain bleed greater than Grade 1, but it's now resolved.I am currently on antibiotics or antifungal treatment for an infection.I agree to use birth control to prevent pregnancy for 6 months after my last dose.I have a brain condition not related to my cancer.I am taking high doses of steroids for an autoimmune disease.I have been treated with drugs that target the immune system.I don't have any serious health issues that could make this study unsafe for me.I haven't had any cancer except for certain types in the last 3 years.I have an autoimmune disease, but it's not one of the exceptions listed.I haven't had major chest radiation or palliative radiation within the specified times before starting the study treatment.I am allergic to retifanlimab or its ingredients.I have had an organ transplant.I have mostly recovered from my surgery.I have not had surgery within the last week.I am 18 years old or older.I am on a stable or decreasing dose of steroids.I can care for myself but may not be able to do active work.My organ and bone marrow functions are normal.I have a new diagnosis of Grade IV brain cancer and had treatment with carmustine wafers.I cannot take pills by mouth or have a stomach condition affecting medication absorption.I plan to use other cancer treatments or the Optune device.My side effects from previous treatments have mostly gone away.I have not received a live vaccine in the last 28 days.My doctor agrees that I can have temozolomide with radiation therapy.I have or had lung scarring or inflammation not caused by an infection.I had a scan within 3 days after my surgery.My cancer has spread outside of my brain.I have experienced severe side effects from previous treatments.My brain tumor has come back or gotten worse.I have only had surgery and carmustine wafer treatment for my GBM.I do not have any unmanaged ongoing illnesses.
- Group 1: Arm A- Retifanlimab and Radiation Therapy
- Group 2: Arm B- Retifanlimab, Radiation Therapy and Temozolomide
- Group 3: Arm C- Radiation Therapy and Temozolomide
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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."
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