TAR-210 for Bladder Cancer

(MoonRISe-1 Trial)

Recruiting at 241 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Erdafitinib, Gemcitabine

Disqualifiers: Allergies, Urethral stricture, Polyuria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

560 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bladder cancer treatment called TAR-210 (an erdafitinib intravesical delivery system) and compares it to other bladder cancer drugs. The researchers aim to determine how well TAR-210 helps patients remain cancer-free compared to standard chemotherapy options. Participants should have intermediate-risk bladder cancer that meets specific criteria, such as multiple small tumors or tumors larger than 3 cm. Those with a specific genetic marker (a change in the FGFR gene) and who are willing to undergo regular bladder checks might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TAR-210 is generally safe and well-tolerated in people with a type of bladder cancer that doesn't invade the muscle. Most side effects are mild and affect the urinary system, involving how the body handles urine. These side effects are usually not serious.

TAR-210 has shown promising results, with many patients showing no signs of cancer after treatment. Additionally, 90% of patients did not experience a recurrence during the study period. This evidence suggests that while TAR-210 can cause some side effects, they are manageable and usually not serious. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

TAR-210 is unique because it offers a new delivery method by being inserted directly into the bladder, where it stays for 12 weeks before being replaced. This contrasts with standard bladder cancer treatments like mitomycin C (MMC) or gemcitabine, which require frequent weekly doses. Researchers are excited about TAR-210 because its prolonged presence might provide continuous treatment with potentially fewer side effects and greater convenience for patients.

What evidence suggests that TAR-210 might be an effective treatment for bladder cancer?

Research has shown that TAR-210, administered to participants in Group A of this trial, holds promise for treating bladder cancer. In earlier studies, patients using TAR-210 had a 90% chance of remaining cancer-free, with their cancer signs completely disappearing. TAR-210 works by slowly releasing medicine directly into the bladder, effectively targeting cancer cells. It is also considered safe, with most people experiencing only mild urinary side effects. These findings suggest TAR-210 could be a strong option for those with intermediate-risk non-muscle invasive bladder cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Johnson & Johnson Enterprise Innovation Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who can perform daily activities (ECOG status 0-2). They must have a specific FGFR mutation or fusion, be willing to undergo study procedures like cystoscopies and tumor removal, and have no remaining visible disease before starting the trial. People with another malignancy that won't affect the study are also eligible.

Inclusion Criteria

My cancer has a specific FGFR mutation.

I may have another cancer, but it won't affect this study's treatment.

I am willing to follow all study procedures and accept the assigned treatment.

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to any study component or its excipients

I have not fully recovered from major surgery or a significant injury within the last 4 weeks.

Polyuria with recorded 24-hour urine volumes greater than 4000 mL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year. Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years and 2 months

What Are the Treatments Tested in This Trial?

Interventions

• TAR-210

Trial Overview The study aims to compare how well patients do without their bladder cancer returning when treated with TAR-210 versus standard single-agent intravesical chemotherapy such as Gemcitabine or MMC. Participants will be randomly assigned to receive one of these treatments.

How Is the Trial Designed?

Group I: Group A: TAR-210 Experimental Treatment 1 Intervention

Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.

Group II: Group B: MMC or Gemcitabine Active Control 2 Interventions

Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.

TAR-210 is already approved in United States for the following indications:

Approved in United States as BALVERSA for:

• Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

A 58-year-old man developed blurry vision and secondary maculopathy after 3 weeks of treatment with erdafitinib for bladder cancer, indicating potential ocular toxicity associated with this medication.

Discontinuation of erdafitinib led to improvements in both vision and eye health, highlighting the need for monitoring ocular side effects in patients receiving FGFR inhibitors like erdafitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erdafitinib-Induced Secondary Maculopathy. Becker, B., El Hamichi, S., Gold, AS., et al.[2023]

Erdafitinib is a newly approved pan-FGFR inhibitor specifically for treating locally advanced or metastatic urothelial carcinoma associated with FGFR3 or FGFR2 mutations.

The drug is also being explored for its potential effectiveness against various other cancers, including cholangiocarcinoma and non-small cell lung cancer, indicating its broad therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erdafitinib: First Global Approval. Markham, A.[2020]

In the BLC2001 study involving 212 participants with advanced urothelial carcinoma, 40% of those treated with an 8 mg daily dose of erdafitinib experienced a reduction in tumor size or complete disappearance of tumors, indicating its efficacy in this difficult-to-treat cancer.

Approximately 80% of participants achieved disease control, meaning their tumors either shrank or remained stable, with an estimated 55% survival rate after one year and 31% after two years, highlighting the potential of erdafitinib as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plain language summary of erdafitinib in locally advanced or metastatic urothelial carcinoma: a phase 2 study with long-term follow-up. Loriot, Y., O'Hagan, A., Siefker-Radtke, AO.[2023]

In a long-term follow-up of the BLC2001 study involving 101 patients with advanced urothelial carcinoma, erdafitinib demonstrated a 40% objective response rate, indicating its efficacy in this patient population with specific FGFR alterations.

The safety profile of erdafitinib remained consistent over time, with 71% of patients experiencing grade 3-4 adverse events, but no new safety concerns were identified, suggesting it is a manageable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Siefker-Radtke, AO., Necchi, A., Park, SH., et al.[2022]

In a phase III study involving 351 patients with metastatic urothelial carcinoma, erdafitinib and pembrolizumab showed similar overall survival rates, with median survival times of 10.9 months and 11.1 months, respectively.

Erdafitinib demonstrated a higher objective response rate (40.0% vs. 21.6%) compared to pembrolizumab, although the duration of response was shorter for erdafitinib (4.3 months vs. 14.4 months), indicating that while erdafitinib may lead to more immediate responses, pembrolizumab may provide longer-lasting effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: cohort 2 of the randomized phase III THOR trial. Siefker-Radtke, AO., Matsubara, N., Park, SH., et al.[2023]

Erdafitinib is the first FDA-approved oral medication that targets multiple fibroblast growth factor receptors (FGFR-1 to -4), leading to reduced cell signaling and increased cancer cell death, making it a novel treatment for urothelial carcinoma.

This drug is specifically approved for adult patients with advanced urothelial carcinoma who have certain genetic alterations in FGFR3 or FGFR2 and have not responded to previous platinum-based chemotherapy, providing a new option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erdafitinib to treat urothelial carcinoma. Hanna, KS.[2019]

Erdafitinib, a tyrosine kinase inhibitor for advanced urothelial carcinoma, was studied using a pharmacokinetic model in mice and rats to determine effective dosing for phase 1 trials, showing that doses above 4 mg/day resulted in significant tumor growth inhibition.

The modeling predicted that efficacious unbound concentrations of erdafitinib were identified, aligning with early clinical activity observed at a dose of 6 mg in the first-in-human trial, demonstrating the potential of translational modeling in optimizing drug dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A translational model-based approach to inform the choice of the dose in phase 1 oncology trials: the case study of erdafitinib. Tosca, EM., Terranova, N., Stuyckens, K., et al.[2022]

Citations

1. urotoday.com urotoday.com/conference-highlights/eau-2024/eau-2024-bladder-cancer/151001-eau-2024-first-safety-and-efficacy-results-of-the-tar-210-erdafitinib-intravesical-delivery-system-in-patients-with-non-muscle-invasive-bladder-cancer-with-select-fgfr-alterations.html

First Safety and Efficacy Results of the TAR-210 Erdafitinib ... TAR-210 shows promising clinical activity in patients with FGFR-altered high-risk and intermediate-risk non-muscle invasive bladder cancer with ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)04274-6/fulltext

LBA104 First safety and efficacy results of the TAR-210 ... Conclusions. TAR-210 appears safe and well tolerated with predominantly low-grade urinary system AEs and high CR rate and RF survival in pts with NMIBC with ...

3. jnj.com jnj.com/media-center/press-releases/tar-210-results-show-90-recurrence-free-survival-and-90-complete-response-in-patients-with-high-risk-and-intermediate-risk-non-muscle-invasive-bladder-cancer-respectively

TAR-210 results show 90% recurrence-free survival and ... TAR-210 results show 90% recurrence-free survival and 90% complete response in patients with high-risk and intermediate-risk non–muscle-invasive bladder cancer ...

4. auajournals.org auajournals.org/doi/10.1097/01.JU.0001008712.53259.7d.02

PD48-02 FIRST SAFETY AND EFFICACY RESULTS OF ... TAR-210 appears safe and well tolerated with predominantly low-grade urinary system TRAEs and high CR rate and RF survival in patients with NMIBC with FGFRalt.

5. urotoday.com urotoday.com/conference-highlights/aua-2024/aua-2024-bladder-cancer/151853-aua-2024-first-safety-and-efficacy-results-of-the-tar-210-erdafitinib-intravesical-delivery-system-in-patients-with-non-muscle-invasive-bladder-cancer-with-select-fgfr-alterations.html

First Safety and Efficacy Results of the TAR-210 Erdafitinib ... TAR-210, an innovative intravesical drug delivery system, offers localized and sustained release of erdafitinib within the bladder for up to 90 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05316155

NCT05316155 | Study of Erdafitinib Intravesical Delivery ... The study consists of a screening phase, a treatment phase, and a follow-up phase. Total duration of the study is 5 years 11 months.