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Monoclonal Antibodies
Erdafitinib Combo for Bladder Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic or locally advanced urothelial cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years 1 month
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new drug combination for people with urothelial cancer.
Who is the study for?
This trial is for adults with advanced or metastatic urothelial cancer, specifically transitional cell carcinoma. Participants must have measurable disease and no prior systemic therapy for metastatic disease (or are cisplatin-ineligible). They should not have received certain treatments recently and must have adequate kidney function.Check my eligibility
What is being tested?
The study tests the safety, tolerability, and optimal dosing of erdafitinib alone or combined with cetrelimab and platinum-based chemotherapy (cisplatin or carboplatin) in patients. It aims to find the best dose for Phase 2 trials and assess how well these combinations work against this type of cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as skin rash, fatigue, digestive issues like nausea or diarrhea; liver enzyme changes; potential kidney function alteration; blood count variations that could lead to anemia or increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread beyond the bladder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Number of Participants With Dose-Limiting Toxicity (DLTs)
Phase 2: Number of Participants With Treatment-emergent Adverse Event (TEAEs)
Phase 2: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator Assessment
Secondary outcome measures
Phase 1b and Phase 2: Number of Participants With Anti-Cetrelimab Antibodies
Phase 1b and Phase 2: Plasma Concentration of Erdafitinib
Phase 1b and Phase 2: Serum Concentration of Cetrelimab
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2: Dose ExpansionExperimental Treatment2 Interventions
The participants will be randomized in a 1:1 manner to receive either erdafitinib alone (orally) or the identified RP2D of Phase 1b for erdafitinib (orally) in combination with cetrelimab (IV).
Group II: Phase 1b: Dose EscalationExperimental Treatment4 Interventions
Two dosing cohorts (erdafitinib and cetrelimab; and erdafitinib, cetrelimab and cisplatin/carboplatin) are explored in Phase 1b of the study. Participants will receive erdafitinib orally followed by cetrelimab intravenously (IV) and carboplatin/cisplatin IV as a part of platinum chemotherapy. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Erdafitinib
2017
Completed Phase 2
~150
Cetrelimab
2022
Completed Phase 1
~20
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,235 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,832 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not receiving treatment for any cancer other than urothelial cancer.My bladder cancer has been confirmed by a biopsy.I've had previous treatments targeting PD-1, PD-L1, or PD-L2, but stopped over a year ago without severe side effects.My cancer has spread beyond the bladder.I have symptoms from cancer spread to my brain.I haven't been in a clinical study or taken experimental drugs in the last 30 days.I haven't had chemotherapy in the last 3 weeks or had it over a year ago without severe side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Dose Escalation
- Group 2: Phase 2: Dose Expansion
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.
What conditions is Erdafitinib employed to address?
"Erdafitinib is a commonly prescribed drug for initial treatment and has also been used to combat advanced thymoma, testicular cancer, carcinoma and neuroendocrine maladies."
Answered by AI
Are there currently any vacancies available in this trial?
"Information available on clinicaltrials.gov reveals that recruitment for this medical study has been completed, as the trial was initially posted in April 2018 and most recently updated in November 2022. Nonetheless, there are still 1368 additional trials actively seeking participants at the present time."
Answered by AI
What goals is this research endeavor aiming to accomplish?
"According to the research and development division of Janssen, main objective that will be monitored over an 8-week span is adverse event (AE) occurrence. Furthermore, this trial also has established secondary milestones such as response time since randomization, abnormal laboratory values, and anti-cetrelimab antibody production amongst participants."
Answered by AI
Could you provide a synopsis of the research that has been conducted on Erdafitinib?
"Currently, Erdafitinib is being tested in 1154 live trials with 380 of those studies taking place during Phase 3. Despite the preponderance of clinical research based out of Shanghai, there are 68271 sites operating trials for this drug throughout the world."
Answered by AI
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