Health TrialsbyHealthPanel

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

ConditionNon-Muscle Invasive Bladder Neoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and evaluate preliminary clinical efficacy. Part 3 (dose expansion) will confirm safety and preliminary clinical activity at the RP2D. Part 4 (RP2D expansion; MoonRISe-2) will assess the overall complete response (CR) in participants with intermediate-risk-non-muscle invasive bladder cancer (IR-NMIBC; means the cancer cells are only in the bladder's inner lining).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Muscle-invasive or recurrent, non-muscle-invasive urothelial carcinoma of the bladder

For selected Cohorts: Activating tumor pan-fibroblast growth factor receptor (FGFR) mutation or fusion, as determined by local or central testing, approved by the sponsor prior to the start of study treatment. Local tissue-based results (if already existing) from next-generation sequencing (NGS) or polymerase chain reaction (PCR) tests performed in Clinical Laboratory Improvement Amendments (CLIA) -certified or equivalent laboratories, or results from commercially available PCR or NGS tests

Cohorts 1 and 2: Bacillus Calmette-Guérin (BCG) experienced, or participants with no BCG experience because BCG was not available as a treatment option in the participant's location within the previous 2 years and is currently unavailable. Participants who received an abbreviated course of BCG due to toxicity are still eligible

Cohort 1 only: Refuses or is not eligible for radical cystectomy (RC)

Disqualifiers

Concurrent extra-vesical (that is, urethra, ureter, renal pelvis) transitional cell carcinoma of the urothelium

Prior treatment with an pan-fibroblast growth factor receptor (FGFR) inhibitor

Received pelvic radiotherapy <=6 months prior to the planned start of study treatment. If received pelvic radiotherapy greater than (>)6 months prior to the start of study treatment, there must be no cystoscopic evidence of radiation cystitis

Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe use of Erdafitinib intravesical delivery system

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erdafitinib Intravesical Delivery System

    Drug

    Erdafitinib intravesical delivery system will be administered.

Treatment groups

235 Participants
are divided into 4 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose ExpansionExperimental treatment 1 intervention
Group C: Part 3: RP2D Dose ExpansionExperimental treatment 1 intervention
Group D: Part 4: Phase 2 ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Parts 1 to 3: Number of Participants with Adverse Events (AEs)

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Time frame
Up to approximately 7 years 4 months
2

Parts 1 to 3: Number of Participants with AEs by Severity

Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

Time frame
Up to approximately 7 years 4 months
3

Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

Time frame
Up to 28 days
4

Part 4: Overall Complete Response (CR) in Participants with Intermediate Risk-Non-Muscle Invasive Bladder Cancer (IR-NMIBC)

Overall CR is defined as the negative cystoscopy or positive cystoscopy with centrally reviewed biopsy negative for malignancy.

Time frame
Up to approximately 7 years 4 months

Secondary outcomes

1

Parts 1 to 3: Plasma Concentration of Erdafitinib

Plasma concentration of Erdafitinib will be reported.

Time frame
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
2

Parts 1 to 3: Urine Concentration of Erdafitinib

Urine concentration of Erdafitinib will be reported.

Time frame
Cohorts 1, 3 and 5: up to 6 months; Cohort 2 and 4: up to 8 weeks
3

Parts 1 to 3: Cohorts 1 and 2: Recurrence-Free Survival (RFS)

RFS is defined as the time from start of treatment to the first detection of any new high-grade bladder cancer or upper tract urothelial carcinoma or positive urine cytology.

Time frame
Up to approximately 7 years 4 months
4

Parts 1 to 3: Cohort 3 and 5: Complete Response (CR) Rate

CR is defined as the absence of urothelial carcinoma by cystoscopy, confirmed pathologically at first assessment, and negative urine cytology.

Time frame
At 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Janssen Research & Development, LLC

Lead sponsor

Source ClinicalTrials.gov
Apply now