TAR-210 for Bladder Cancer

(MoonRISe-3 Trial)

Recruiting at 37 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must be taking: BCG

Disqualifiers: CIS, Muscle-invasive cancer, Active malignancies, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 years

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores treatments for high-risk non-muscle-invasive bladder cancer, focusing on how long patients can remain cancer-free. One group will receive a new treatment called TAR-210, a device that releases medication directly into the bladder and remains there for about two years. The other group will receive traditional bladder cancer treatments like mitomycin C or gemcitabine. Individuals who have had their bladder tumors removed and possess a specific genetic marker (FGFR mutation or fusion) might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

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. Studies indicate it mostly causes mild side effects, primarily affecting the urinary system, meaning the side effects are not very serious. The treatment releases medication directly into the bladder, reducing side effects in other parts of the body. This approach limits harm to the whole body.

For those considering the trial, this information suggests that TAR-210 is a promising option with a good safety record based on previous studies. ^{1 2 3 4 5}

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

Unlike the standard treatments for bladder cancer, which often involve chemotherapy drugs like Mitomycin C and Gemcitabine, TAR-210 is unique because it delivers therapy directly to the bladder over an extended period. This new approach uses a sustained-release mechanism, allowing the treatment to be administered once and work continuously for up to two years. Researchers are excited about TAR-210 because it potentially offers a more consistent therapeutic effect, reducing the frequency of hospital visits and improving patient convenience compared to traditional weekly or monthly dosing schedules.

What evidence suggests that this trial's treatments could be effective for high-risk non-muscle-invasive bladder cancer?

Research shows that TAR-210, which participants in Group A of this trial will receive, is a promising treatment for high-risk non-muscle-invasive bladder cancer (HR-NMIBC). In earlier studies, 90% of patients who received TAR-210 experienced no recurrence, and their cancer completely disappeared. TAR-210 proved to be safe and generally well-tolerated, with mostly mild side effects. This treatment works especially well for patients whose cancer has specific genetic changes known as FGFR alterations. Overall, TAR-210 has strong potential to prevent this type of bladder cancer from returning. ^{2 4 6 7 8}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with high-risk non-muscle-invasive bladder cancer who've had some treatment with BCG but still have signs of cancer or can't tolerate more BCG. They need to have a certain mutation, no muscle invasion by the cancer, and be in decent physical shape. People who are eligible for or want to undergo complete bladder removal surgery cannot join.

Inclusion Criteria

My bladder cancer is high-grade but hasn't invaded the muscle.

My cancer has a specific FGFR mutation or fusion.

All visible cancer has been surgically removed, and my urine test for cancer is clear.

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 for approximately 2 years. Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine once weekly for 4 to 6 induction doses followed by maintenance dosing once monthly for up to 1 year, with an optional second year of additional maintenance.

1-2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures assessed up to 5 years.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Mitomycin C
• TAR-210

Trial Overview The study compares TAR-210, a new potential treatment, against the doctor's choice of standard chemotherapy drugs (Mitomycin C or Gemcitabine) in patients previously treated with BCG. The main goal is to see which group stays free from cancer symptoms longer after starting their assigned treatment.

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. TAR-210 will be inserted over a treatment duration of approximately 2 years.

Group II: Group B: Mitomycin C (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 maintenance dosing once monthly for up to 1 year. An optional second year of additional maintenance can be added at the investigator's discretion.

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

Citations

1. 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 ...

2. 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 ...

3. 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.

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

LBA104 First safety and efficacy results of the TAR-210 ... As of Aug 29, 2023, 16 pts in C1 and 27 pts in C3 have been treated; 11 and 15 pts, respectively, had ≥1 response assessment. 82% in C1 were RF; 87% in C3 ...

5. targetedonc.com targetedonc.com/view/fgfr-altered-nmibc-treatment-advances-with-tar-210-findings

FGFR-Altered NMIBC Treatment Advances With TAR-210 ... TAR-210 led to early clinical activity in patients with FGFR-altered high- and intermediate-risk non–muscle invasive bladder cancer (NMIBC).

6. 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 is a novel intravesical drug delivery system designed to provide local, continuous release of targeted therapy, including Erdafitinib within the ...

7. asco.org asco.org/abstracts-presentations/ABSTRACT394836

Safety and efficacy of the erdafitinib (erda) intravesical ... TAR-210 is an intravesical drug delivery system designed to provide local, continuous release of erda within the bladder, thus limiting systemic toxicity.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06919965

NCT06919965 | A Study to Evaluate TAR-210 Versus ... Participants in Group A will have TAR-210 inserted in the bladder on Day 1. TAR-210 will be inserted over a treatment duration of approximately 2 years.