Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

This research is looking into new treatments for advanced bladder cancer (urothelial cancer) when it has spread or is locally advanced. The study focuses on erdafitinib, a drug that targets specific genetic changes in cancer cells. It explores using erdafitinib on its own, and in combination with another drug called cetrelimab, or with standard chemotherapy (cisplatin or carboplatin). The main goals are to find the safest and most effective doses of these drug combinations and to understand their side effects. Researchers will also evaluate how well these treatments shrink tumours and improve quality of life for patients who have specific changes in their fibroblast growth factor receptor (FGFR) genes. This is particularly important for patients who haven't had prior treatment for their advanced cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

125

Start

05 Apr 2018

Estimated completion

31 Dec 2026

Urothelial Carcinoma

What is this study about?

This important study is exploring new treatment options for a type of bladder cancer called urothelial cancer, when it has become advanced or has spread. It focuses on patients whose cancer has specific changes in something called the fibroblast growth factor receptor (FGFR) gene. These genetic changes can sometimes make cancer cells grow more quickly, so targeting them with specific drugs could be helpful.

The study is testing a drug called erdafitinib, which is designed to block the effects of these FGFR gene changes. It's looking at different treatment approaches: erdafitinib on its own, erdafitinib combined with another drug called cetrelimab, and erdafitinib combined with cetrelimab plus standard chemotherapy drugs (cisplatin or carboplatin). The aim is to understand how safe these combinations are, what the best doses might be, and how effective they are at treating the cancer.

The study is divided into two main parts. The first part (Phase 1b) is about finding the safest doses for the drug combinations. The second part (Phase 2) will then evaluate the safety and how well the most promising dose combinations work. This research is crucial because it could lead to new ways to help patients with advanced urothelial cancer, especially those with specific genetic markers, and those who may not be able to receive standard chemotherapy.

Key takeaways

This study is for advanced bladder cancer (urothelial cancer) with specific genetic changes.
It tests new drug combinations involving erdafitinib, cetrelimab, and chemotherapy.
The main goals are to find safe doses and understand how well treatments work.
Some parts of the study are for patients who haven't had prior treatment for their advanced cancer.
It's an 'open-label' study, meaning you will know which treatment you are receiving.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, your doctor would first confirm you have bladder cancer (urothelial cancer) that is advanced or has spread. Your cancer would also need to show specific changes in the fibroblast growth factor receptor (FGFR) gene.

Different parts of the study have slightly different requirements for whether you've had previous treatments for your advanced cancer. Some parts are for people who haven't had any prior treatment for their advanced disease, while others might allow for some previous therapies. Crucially, if you are unable to receive the chemotherapy drug cisplatin due to kidney function, nerve damage, or hearing loss, or if you are generally unwell, you might be eligible for certain parts of the study.

Your overall health and how well you can perform daily activities (known as your 'performance status') will also be checked. Generally, you need to be aged 18 or over. There are also specific medical conditions and recent treatments that would prevent you from taking part, such as having received certain other cancer treatments recently or participating in another clinical trial within the last 30 days.

Quick self-check

Do you have advanced or metastatic bladder cancer (urothelial cancer)?
Does your cancer tissue show specific FGFR gene changes?
Have you not had previous systemic treatment for your advanced cancer (for some parts of the study)?
Are you potentially unable to receive standard cisplatin chemotherapy?
Are you generally feeling well enough (your doctor will assess this)?
Are you 18 years of age or older?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it will involve several phases: screening, treatment, and follow-up. During the screening phase, you'll undergo various tests to ensure you meet all the study's requirements. This will include blood tests, imaging scans to check your cancer, and other assessments.

During the treatment phase, you will receive the assigned study medication(s) according to a specific schedule. This will involve regular visits to the hospital for treatment administration and close monitoring. You'll have ongoing evaluations of your health, potential side effects, and how your body reacts to the medication. This could include further blood tests, urine tests, imaging scans, and physical examinations.

The study will also look at how the drugs move through your body (pharmacokinetics), how they affect your cancer at a cellular level (pharmacodynamics and biomarkers), and how your immune system responds. After your treatment phase is complete, you'll enter a follow-up phase where your health will continue to be monitored for a period to track long-term effects and outcomes.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as accessing new treatments not yet widely available and contributing to medical knowledge that could help future patients. However, there are also potential risks, including side effects from the study drugs that are not yet fully understood, and the possibility that the treatment may not work for you. All medical treatments carry risks, and the study team will monitor you closely for any adverse effects. You will receive detailed information about all known and potential risks before deciding to participate. Your safety and well-being are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (127)

Rocky Mountain Cancer Centers
Aurora, United States
Norton Cancer Institute
Louisville, United States
Maryland Oncology Hematology, PA
Rockville, United States
Hackensack University Medical Center
Hackensack, United States
Weill Cornell Medical College - NY Presbyterian Hospital
New York, United States
White Plains Hospital Center for Cancer Care
White Plains, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, United States
Toledo Clinic Cancer Centers
Toledo, United States
Penn State Hershey Cancer Institute
Hershey, United States
Texas Oncology, P.A.
Fort Worth, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Virginia Oncology Associates
Norfolk, United States

+115 more sites — see the official record for the full list.

Common questions

What is urothelial cancer?

Urothelial cancer is the most common type of bladder cancer, which starts in the cells lining the bladder and other parts of the urinary system.

What does 'metastatic' or 'locally advanced' mean?

Metastatic means the cancer has spread to other parts of the body. Locally advanced means the cancer has grown into nearby tissues but hasn't spread to distant organs.

What are FGFR gene alterations?

These are specific changes in the genes of your cancer cells that can make the cancer grow. This study is for people whose cancer has these particular changes.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, meaning everyone involved, including you and the study team, will know which treatment you are receiving.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.