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ATRA + PD-1 Inhibitor for Brain Tumor
Study Summary
This trial is testing a new combination of drugs to treat recurrent IDH-mutant glioma. The Sponsor-Investigator believes the proposed regimen will be safe and stimulate a robust anti-tumor immune response.
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.Side effects data
From 2021 Phase 2 trial • 94 Patients • NCT03597295Trial Design
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- My MRI shows my tumor is either larger than 1cmx1cm or has grown by at least 25% since my last treatment.My tumor has a confirmed IDH1 or IDH2 mutation.I have tried temozolomide or another similar drug without success.I have tried temozolomide and another alkylator drug without success.I have not used 5-ALA for tumor visualization due to its reaction with ATRA.I am 18 years old or older.I have active hepatitis B or C.I haven't taken immunosuppressive drugs, except steroids, in the last 6 months.I am taking high doses of steroids for an autoimmune disease.I can have an MRI with contrast and haven't increased my steroid dose in 5 days.I can swallow pills.I do not have any serious health issues that could worsen with this study's treatment.I have not taken bevacizumab in the last 3 months.I can care for myself but may not be able to do active work.My organs and bone marrow are working well.I have had or will have genetic testing for 1p/19q and MGMT before joining.I have not received a live vaccine in the last 28 days.I have recovered from the major side effects of my previous cancer treatments.I have tried temozolomide and another alkylator without success.My cancer has spread to the lining of my brain and spinal cord.I have serious heart problems that are not under control.I have or had lung scarring or inflammation not caused by an infection.I have a tumor in my brainstem or spinal cord that shows up on scans, but I don't have a known tumor in my spinal cord.My MRI shows my tumor is either larger than 1cm or has grown by at least 25% since my last treatment.I do not have another cancer that could affect this trial's safety or results.I am allergic to tretinoin or similar medications.I am HIV-positive and currently on antiretroviral therapy.I have had multiple relapses and treatments for my condition.My doctors recommend surgery for my possibly returning or worsening tumor.I have a significant brain swelling or shift.I have tried temozolomide or another similar drug without success.I've had one chemotherapy treatment that didn't work and it's been over a year since my last treatment.I had severe side effects from previous immunotherapy that required stopping the treatment.I am not allergic to retifanlimab or its ingredients.I have had a solid organ or bone marrow transplant.I have a confirmed diagnosis of astrocytoma or oligodendroglioma that has worsened or returned after chemotherapy.My tumor has a confirmed IDH1 or IDH2 mutation.I haven't used 5-ALA for surgery because it reacts with my ATRA treatment.I understand the study and agree to participate by signing the consent form.My glioma has worsened after chemotherapy, possibly including temozolomide or lomustine.
- Group 1: Arm B (failed only one prior alkylating chemotherapy)
- Group 2: Arm C (surgical arm, ATRA alone pre-operatively)
- Group 3: Arm D (surgical arm, ATRA + retifanlimab pre-operatively)
- Group 4: Arm A (failed prior TMZ + one other alkylating chemotherapy)
- 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
Are there still opportunities to participate in this research?
"The clinical trial in question, which can be found on clinicaltrials.gov, is not looking for any more patients at this moment in time. Although the study was originally posted on November 1st 2022 and edited as recently as October 6th of the same year, there are 403 other trials that are actively recruiting right now."
Has Retifanlimab undergone FDA testing for safety and efficacy?
"While there is some data supporting Retifanlimab's safety, it received a score of 2 because this is only a Phase 2 trial and there is no evidence yet of the medication's efficacy."
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What portion of applicants met pre-screening criteria?
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