MoonRISe-3

An aspect marked incomplete is a question the public commentary did not let us answer. We show it rather than hide it.

Screened window

Apr 28, 2025 → May 17, 2026

Cited window

Apr 28, 2025 → May 17, 2026

Retrieved

Oct 19, 2026

Title

A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)

Registry

NCT06919965

Study IDs

42756493BLC3005 · 2024-519493-39-00 (EUCT number)

Sponsor

Janssen Research & Development, LLC

Design

Phase 3 · Interventional, randomized, parallel

Status

Recruiting

Enrollment

220 estimated

Start

2025-09-10 actual

Primary completion

2028-04-06 estimated

Primary endpoint

Disease-free Survival (DFS)

Interventions

3 registered

This report does not judge efficacy, estimate HCP prevalence or consensus or give treatment advice.

• –Discussion that does not name the trial may be missing from this edition.
• –Some clinician views in the sources used in this report are not yet captured as evidence in this edition; the next refresh takes them up.
• –Some passages in the sources used in this report were not fully assessed for clinician views, so a view there may be missing from this edition.
• –Out of scope: 3 passages in the reviewed sources discuss other trials or topics outside this report's scope; they are not part of this edition.
• –188 statements in the sources reviewed for this edition discuss other treatment settings or topics unrelated to this trial's question and are not included.
• –Further source limits: discussion that describes the trial without naming it may be incomplete; some discussion that describes the trial without naming it may be missing; sources about other trials are not included.
• –The sources reviewed provide qualitative views, not a representative estimate of HCP agreement, treatment use or patient outcomes.
• –Podcast and video coverage overlaps for the March 2026-published educational session; source totals must not be interpreted as independent clinician totals.
• –Discussions using unnamed references or different wording may be absent. Two relevant passages were not fully assessed; additional views and qualifications concerning treatment alternatives, toxicity, patient selection and evidence limitations may be missing.
• –No full protocol or results publication for NCT06919965 was available among the reviewed materials. The report cannot independently assess all eligibility details, endpoint definitions or comparative results.
• –Earlier TAR-210 recurrence estimates came from separate source accounts and were explicitly preliminary; their numerical differences cannot be reconciled from these statements.
• –Some connected post-BCG counseling discussions did not state FGFR status. Other alternative-treatment opinions expressly concerned BCG-refractory CIS. These discussions inform the treatment decision but do not demonstrate eligibility for, or efficacy in, MoonRISe-3.
• –Joanna Sadowska Aka Dr Jojo's individual identity is unverified and the sources reviewed do not establish a clinical role. Félix Guerrero-Ramos's individual identity is also unverified.
• –Exact TAR-210 and mitomycin C labels were not available among the reviewed materials. Speakers' approval, availability and geographic-access remarks are not a current labeling or reimbursement assessment. The case presenter's TAR-200 availability statement was relative to the presentation, not evidence of current access in every country.
• –Source publication dates do not establish the date of every session, readout or recruitment milestone, and do not by themselves demonstrate a change of mind.

How reports are built and checked: Methods.

Last checked for new commentary Oct 19, 2026. A new or changed finding gets a new version number; added evidence alone is a smaller update. No corrections.