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Erdafitinib + Enfortumab Vedotin for Bladder Cancer
Study Summary
This trial is testing a combination of two drugs to treat bladder cancer that has spread to other places in the body and has genetic alterations in FGFR2/3 genes. The first drug, erdafitinib, works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. The second drug, enfortumab vedotin, is a monoclonal antibody that attaches to a protein called nectin-4 on cancer cells and delivers an anticancer drug to kill them. The combination of these two drugs may help to shrink or stabilize the cancer.
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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- Your bilirubin levels must be within a certain range to join the study.You have enough infection-fighting white blood cells in your body.My cancer got worse after treatment with platinum drugs and immune therapy.My cancer has FGFR2/3 changes confirmed by a specific blood or tissue test.I had hepatitis C but have been treated and cured.My bladder cancer returned within a year after completing platinum-based therapy.I have had an eye exam and do not have any active eye diseases.I am HIV-positive, on treatment, and my viral load is undetectable.My cancer is advanced bladder cancer confirmed by lab tests.My kidney function, measured by creatinine clearance, is normal or only slightly reduced.I had prostate cancer treated over a year ago, it was early stage and not aggressive.I agree to use contraception during and for 5 months after the study.I have a history of eye conditions that could increase the risk of eye side effects.You have had allergic reactions to similar drugs like erdafitinib and enfortumab vedotin.Your hemoglobin level is 9 grams per deciliter or higher.I have been treated with an FGFR inhibitor before.I have not had radiotherapy in the last 2 weeks.My cancer has a mainly transitional cell pattern.I've had platinum-based treatment for advanced or inoperable lung cancer.Your platelet count is at least 100,000 per microliter.My brain scans show no worsening after treatment for brain metastases.Patients must have a specific amount of detectable disease as defined by the RECIST version 1.1.I am not taking any strong medication that affects liver enzymes.I have not had another invasive cancer in the last 3 years.Your phosphate levels have been consistently higher than the normal range during screening and before the start of treatment.I have advanced bladder cancer, can't take cisplatin, and my cancer worsened after or I can't/refused to take immune therapy.My hepatitis B virus is under control with treatment.I agree to use birth control during and for 3 months after the study.I have previously been treated with an antibody drug like sacituzumab govitecan.My diabetes is not under control.I haven't had cancer treatment or experimental drugs in the last 2 weeks.I am not currently being treated for an active infection.I have not had major surgery in the last 4 weeks.You have had a transplant using cells or organs from another person.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.Your AST and ALT levels are not more than 2.5 times the normal limit (or not more than 5 times the normal limit if you have liver metastasis).My cancer returned or worsened within 12 months after completing immune therapy.I have previously been treated with enfortumab vedotin or similar drugs.I have recovered from side effects of previous cancer treatments, except for hair loss.I have a history of or currently have uncontrolled heart problems.
- Group 1: Treatment (erdafitinib, enfortumab vedotin)
- 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
Could you please tell me what Erdafitinib's side effects are?
"Erdafitinib's safety was given a score of 1 because there is only limited data from phase 1 trials supporting its efficacy and safety."
Which conditions does Erdafitinib commonly target?
"Erdafitinib is the most common pharmacotherapy used to treat this condition. However, Erdafitinib is also useful for treating locally advanced urothelial cancer, metastatic susceptible fgfr3 or fgfr2 genetic alterations, and condition that has progressed during or following at least one line of prior platinum- containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy metastatic urothelial carcinoma."
Does this type of trial exist?
"At this moment in time, there are 31 ongoing medical trials for Erdafitinib in 1127 distinct metropolises and 48 countries. The first study occurred in 2014 and was completed by Seagen Inc. This initial study had 213 participants and completed Phase 1 of drug approval. In the 6 years since 2014, 13 more trials have been completed."
Is this clinical trial being run at a significant number of North American medical facilities?
"At the moment, this clinical trial is being conducted in 5 different locations. They are situated in Salt Lake City and Los Angeles as well as other cities. If you are thinking about enrolling, please pick the centre that is closest to your home to reduce travel time demands."
How many people are permitted to join this scientific experiment?
"In order to start this study, we need 30 people who fit the bill. If you're eligible and interested, you can sign up at either the Huntsman Cancer Institute/University of Utah in Salt Lake City, UT or USC / Norris Comprehensive Cancer Center in Los Angeles, CA."
What are researchers hoping to find out at the conclusion of this trial?
"The primary goals of this study, which will last for up to two years, is to assess the Recommended phase II dose. Additionally, the study will also collect data on Overall response rate, defined as Will be summarized using descriptive statistics including two-sided 95% confidence interval (CI) based on Clopper-Pearson method., Overall survival, defined as Kaplan-Meier curve estimates of medians and their corresponding 95% CIs will be calculated., and Progression free survival, defined as Kaplan-Meier curve estimates of medians and their corresponding 95% CIs will be calculated.."
If a patient is interested, how can they sign up for this trial?
"Yes, this trial is still seeking patients. The listing on clinicaltrials.gov shows that the trial was first posted on October 13th, 2021 and was last updated on September 23rd, 2022."
Could you please provide a synopsis of other trials that have used Erdafitinib?
"There are currently 31 ongoing clinical trials studying the effects of Erdafitinib. Of these, 7 have progressed to Phase 3 testing. The vast majority of these trials are taking place in Den Haag and Utrecht, but there are 4068 total locations worldwide where these studies are being conducted."
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