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Kinase Inhibitor
Arm I (erdafitinib) for Bladder Cancer
Phase 2
Waitlist Available
Led By Di Maria Jiang
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests whether a drug combo of erdafitinib & atezolizumab works on bladder cancer cells with a gene alteration. It may stop cancer cells from growing & help immune attack them.
Eligible Conditions
- Bladder Cancer
- Urothelial Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathological complete response (pCR)
Secondary outcome measures
Clinical complete response (cCR) rate among patients who do not undergo RC
Disease-free survival (DFS)
Incidence of adverse events
+3 moreOther outcome measures
Clinical staging (cT2N0 vs. cT3/T4 or N)
Cell fusion procedure
Fibroblast Growth Factor
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (erdafitinib, atezolizumab)Experimental Treatment6 Interventions
Patients receive erdafitinib PO and atezolizumab intravenously (IV). Patients undergo collection of blood and CT/MRI at various time points throughout the trial and colposcopy at baseline.
Group II: Arm I (erdafitinib)Experimental Treatment5 Interventions
Patients receive erdafitinib orally (PO). Patients undergo collection of blood and computed tomography (CT)/magnetic resonance imaging (MRI) at various time points throughout the trial and colposcopy at baseline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Cystoscopy
2016
Completed Phase 4
~810
Erdafitinib
2017
Completed Phase 2
~150
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
Di Maria JiangPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with urothelial carcinoma, which is a type of bladder cancer. If you have a different type of bladder cancer, it must be mostly urothelial carcinoma (at least 50% of the cancer cells).You have cancer that has not spread to other parts of your body, but has grown beyond its original location. Your doctor used CT or MRI scans to determine this, not ultrasound, PET scans, or plain x-rays.You have a known primary immune system disorder.You have had a bone marrow or solid organ transplant before.You have cancer that has spread to other parts of your body.You are experiencing uncontrolled pain related to your tumor.You have had or are at risk of autoimmune disease, except for controlled Type 1 diabetes mellitus and autoimmune-related hypothyroidism.You can participate if you haven't received PD-1/PD-1 ICIs for NMIBC in the last year. You can continue taking hormone-replacement therapy, oral contraceptives, or herbal therapy as long as you stopped taking the herbal therapy at least a week before the start of the trial.You are eligible if you have urothelial carcinoma that has not spread to other parts of the body and is only in the upper urinary tract.You had another type of cancer within the past two years, except for types that are low risk of spreading or causing death.You have bladder cancer that has invaded the muscle wall, and this has been confirmed by a surgical procedure called transurethral resection of bladder tumor (TURBT) within the last 8 weeks.You can participate if you have had another type of cancer before, but it was not likely to spread or cause serious harm.You have excessive fluid build-up around your lungs, heart, or abdomen that needs to be drained repeatedly and cannot be controlled.You have any other medical condition, test result, or physical examination finding that may make it unsafe for you to take the experimental drug or may affect the accuracy of the study results.You recently had treatments for cancer and have not fully recovered from the side effects.You have had an allergic reaction to drugs similar to erdafitinib or atezolizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (erdafitinib)
- Group 2: Arm II (erdafitinib, atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project presently enrolling participants?
"According to the entry on clinicaltrials.gov, this medical trial is currently recruiting participants, having been initially posted in October 17th 2022 and edited as recently as November 8th of that year."
Answered by AI
What is the upper limit of participants in this investigation?
"Affirmative. Clinicaltrials.gov records demonstrate that this trial, which was originally posted on October 17th 2022, is actively searching for volunteers. 44 individuals must be enrolled from a single institution."
Answered by AI
What hazards have been identified for people taking Arm II (erdafitinib, atezolizumab)?
"Our evaluation gives the Arm II (erdafitinib, atezolizumab) safety rating a 2 as it is in Phase 2. This signifies that there are some indications of safety yet no proof of efficacy has been established."
Answered by AI
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