A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)

Phase 3RecruitingNCT06929286

Memorial Sloan Kettering Cancer Center125 enrolled

Overview

The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Non-Muscle Invasive Bladder Cancer

Interventions

Nadofaragene FiradenovecDRUG

For patients randomized to receive nadofaragene firadenovec, the patient will receive nadofaragene firadenovec as of normal saline instilled intravesically every 3 months for up to 12 months.

GemcitabineDRUG

gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder

DocetaxelDRUG

followed by docetaxel instilled intravesically for 1 h. This is given once weekly for 6 weeks for induction. Those who have a complete response typically proceed with once-monthly instillations of GemDoce for up to 24 months as maintenance therapy

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 21 years of age or older * Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists at MSK * One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed °Any amount of maintenance BCG is allowed * In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment °An intravesical agent can include BCG or any other NMIBC treatment * In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than "best usual care" Exclusion Criteria: * Opting for treatment with radical cystectomy * Currently enrolled in a clinical trial of an experimental therapy for NMIBC * Prior exposure to nadofaragene firadenovec

Locations (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

high-grade recurrence-free survival

The time from the initiation of treatment to the detection of recurrence of high-grade bladder cancer (biopsy-proven intravesical recurrence or distant metastasis). Biopsy proven high grade intravesical recurrence will be based on the MSK pathology review of the bladder tissue samples.

Time frame: up to 24 months

Secondary Outcomes

Progression-free survival

Disease progression is defined as the development of muscle-invasive disease (stage ≥T2), lymph node or distant metastasis, or death without documented disease progression.

Time frame: up to 24 months

Central Contacts

Eugene Pietzak, MD

CONTACT

646-422-4781 pietzake@mskcc.org

Bernard Bochner, MD

CONTACT

646-422-4387

Data from ClinicalTrials.gov

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