Bladder Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in August 2026

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1: Summary data from new trials identified for Bladder Cancer.

Overview

Number of Trials: 4

Four trials address bladder cancer management (imaging, consolidative therapy, intravesical therapy) and a device-based urinary incontinence intervention in gynecologic cancer survivors. Approaches include PET imaging, radiation/surgery consolidation, hyperthermic chemotherapy, and mechanotherapy devices.

Common Criteria Across Trials

Common Inclusion

Age 18 years or older
Adequate organ function (renal, hepatic, hematologic)
ECOG performance status 0-2
Signed informed consent
Histologic/cytologic confirmation of malignancy or diagnosis

Common Exclusion

Pregnant or breastfeeding individuals
Distant metastasis (in localized disease trials)
Active infection
Life expectancy less than 6 months
Inability to comply with study procedures

Outcomes Summary

Primary Outcomes

Feasibility/safety of intervention (4 trials)

Secondary Outcomes

Quality of life or patient-reported outcomes (2 trials)
Imaging accuracy/detection rate (1 trials)

2: Extracted Trials with New Information

Trials with Special Criteria

Genomic / Biomarker Trials

NCT07664397 — Uses CD46-targeted radiotracer for imaging across multiple malignancies including bladder cancer.

Unique or Unusual Criteria

NCT07579195 — Allows oligometastatic bladder cancer patients with up to 5 extracranial metastatic sites after induction therapy.
NCT07817173 — Excludes patients with prior carcinoma in situ or intraoperative TURBT perforation.
NCT07662824 — Requires smartphone/tablet access and ability to tolerate vaginal wand insertion for device use.

Trials with Emerging Treatments

NCT07579195 — REINFORCE Trial
Items: Enfortumab Vedotin, Pembrolizumab, Consolidative Radiation Therapy, Radical Cystectomy, Radiosensitizing Agent (NVX-108, NBTXR3)
Note: Novel consolidative strategy combining immunotherapy/ADC with radiation or surgery for advanced bladder cancer; radiosensitizers are investigational (Web Search sourced).
NCT07664397 — PET Imaging Study of [89Zr]DFO-YS5
Items: [89Zr]DFO-YS5
Note: Novel CD46-targeted radiotracer for PET imaging, not yet FDA-approved (Web Search sourced).
NCT07817173 — Hyperthermic Irrigation Study
Items: HISA
Note: Investigational modified adenovirus therapy for bladder cancer immune activation, no FDA approval (Web Search sourced).
NCT07662824 — Flyte System Study
Items: Flyte Medical Device
Note: Non-invasive mechanotherapy device for urinary incontinence, novel application in cancer survivors (Web Search sourced).

3: Individual Trial Overviews

NCT07579195

Consolidative Radiation Therapy or Cystectomy After Initial Favorable Response Succeeding Enfortumab Vedotin Plus Pembrolizumab (REINFORCE)--- A Pilot Feasibility Trial

Organization/Sponsor: University of Washington

Example patient: A 65-year-old man with muscle-invasive bladder cancer achieved a partial response after 6 cycles of enfortumab vedotin plus pembrolizumab, has 3 extracranial nodal metastases, ECOG 1, normal organ function, and no CNS disease or prior pelvic radiation.

Pilot/Feasibility

Interventions

Procedure: Questionnaire Administration
Summary: Patient-reported outcome tool assessing quality of life and treatment impact; no biological mechanism. Source: NCI Thesaurus, Web Search.
Procedure: Biospecimen Collection
Summary: Collection of tissue/fluid samples for correlative research into cancer biology and treatment response. Source: NCI Thesaurus, Web Search.
Procedure: Cystoscopy
Summary: Endoscopic bladder examination used for diagnosis, staging, and tissue sampling in bladder cancer. Source: Web Search.
Procedure: Transurethral Resection of Bladder Tumor
Summary: Surgical resection of bladder tumor via cystoscope for diagnosis and local tumor control. Source: Web Search.
Procedure: Magnetic Resonance Imaging
Summary: Noninvasive imaging to assess tumor extent and treatment response. Source: NCI Thesaurus, Web Search.
Procedure: Positron Emission Tomography
Summary: Metabolic imaging using radiotracers to detect metastatic or residual disease. Source: NCI Thesaurus, Web Search.
Procedure: Computed Tomography
Summary: Cross-sectional X-ray imaging used to evaluate tumor response and metastatic disease. Source: NCI Thesaurus, Web Search.
Radiation: Stereotactic Body Radiation Therapy
Summary: High-dose, precisely targeted radiation for oligometastatic or localized lesions, sparing surrounding tissue. Source: NCI Thesaurus, Web Search.
Procedure: Pelvic Lymphadenectomy
Summary: Surgical removal of pelvic lymph nodes, typically performed alongside cystectomy for bladder cancer. Source: Web Search.
Procedure: Radical Cystectomy
Summary: Complete bladder removal, standard curative surgery for muscle-invasive bladder cancer. Source: NCI Thesaurus, Web Search.
Drug: Radiosensitizing Agent
Summary: Agents that enhance radiation efficacy by increasing tumor sensitivity to radiation-induced damage. Source: Web Search.
Radiation: Volume Modulated Arc Therapy
Summary: Rotational radiation delivery technique optimizing dose distribution while sparing healthy tissue. Source: NCI Thesaurus, Web Search.
Radiation: Intensity-Modulated Radiation Therapy
Summary: Radiation technique modulating beam intensity to conform to tumor shape, reducing toxicity to surrounding organs. Source: Web Search.

Key Inclusion

Age >= 18
Muscle invasive bladder cancer cTxN1-3M0, cTxNxM1, or cT4bNxM0
Radiographic CR or PR after 3-9 cycles of enfortumab vedotin + pembrolizumab
If M1, <=5 extracranial metastatic sites
Candidate for consolidative radiation or cystectomy
ECOG performance status 0-2
Adequate hematologic, renal, hepatic, and coagulation function
Controlled HIV infection permitted

Key Exclusion

Prior radiation overlapping planned field
Intracranial metastasis
Small cell, sarcomatoid, or plasmacytoid histology >50%
Other active malignancy within 2 years
Radiosensitivity genetic syndromes (e.g., Fanconi anemia)
Uncontrolled HIV, active hepatitis B or C
Psychiatric or substance abuse disorders impairing compliance
Impaired decision-making capacity

NCT07664397

A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies

Organization/Sponsor: University of California, San Francisco

Example patient: A 62-year-old man with localized bladder cancer confirmed by cystoscopy, ECOG performance status 1, normal organ function, and no contraindications to PET imaging, willing to undergo [89Zr]DFO-YS5 PET-CT scanning.

Pilot

Interventions

Imaging Procedure: Positron Emission Tomography (PET)-Computerized tomography (CT)
Summary: PET/CT detects bladder cancer by imaging glucose metabolism, used for staging and metastasis detection, particularly in muscle-invasive disease. Source: Summary of Web Search.
Imaging Procedure: Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI)
Summary: PET/MRI combines functional and anatomical imaging using radioactive tracers and MRI detail to improve bladder cancer staging and treatment planning. Source: Summary of Web Search.
Radiotracer/Imaging Agent: [89Zr]DFO-YS5
Summary: A radiolabeled monoclonal antibody targeting CD46 used in PET imaging to detect and localize cancer cells, including bladder cancer and other solid tumors. Source: Summary of Web Search.

Key Inclusion

Histologic/cytologic confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor
At least one measurable soft tissue lesion ≥1 cm (exception for localized bladder cancer with cystoscopic confirmation)
Able to undergo PET-CT or PET-MRI imaging
Age ≥ 18 years
ECOG ≤2 or Karnofsky ≥50%
Adequate organ function (liver, renal)
Negative pregnancy test if applicable
Willing to provide informed consent

Key Exclusion

Contraindication to PET-CT or PET-MRI (e.g., claustrophobia, implants)
Pregnant or breastfeeding individuals
Unwillingness to use contraception as specified
Hypersensitivity to [89Zr]DFO-YS5 or excipients
Condition impairing ability to comply with study procedures

NCT07817173

A Pilot Study Using Hyperthermic Irrigation Followed by Intravesical Chemotherapy in Patients With Low- to Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Organization/Sponsor: CAMC Health System

Example patient: A 65-year-old man with a 2 cm papillary bladder tumor undergoes TURBT, has ECOG status 1, normal renal function, and no infection or metastasis, qualifying for the study.

Phase N/A

Interventions

Device/Procedure with Intravesical Chemotherapy: HISA
Summary: HISA (hyperthermic irrigation followed by intravesical chemotherapy) uses heated bladder irrigation combined with intravesical chemotherapy instillation to enhance tumor cell destruction in low- to intermediate-risk non-muscle invasive bladder cancer after TURBT. Source: Summary of Web Search.

Key Inclusion

Age 18-89
Visual diagnosis of papillary tumor(s) ≤3 cm
Transurethral resection of bladder tumor (TURBT) performed
ECOG performance status 0-2
GFR ≥ 30 mL/min

Key Exclusion

Age <18
Pregnant women or prisoners
Evidence of distant metastasis
High-risk NMIBC or prior carcinoma in situ
Active urinary tract infection
Immunosuppression or leukopenia
Intraoperative bladder perforation during TURBT
Postoperative bladder instillation failure

NCT07662824

Flyte System Transvaginal Mechanotherapy for Urinary Incontinence in Endometrial and Cervical Cancer Survivors: A Pilot Study

Organization/Sponsor: Mayo Clinic

Example patient: A 55-year-old English-speaking woman, 4 months post pelvic radiation for cervical cancer, with stress urinary incontinence, able to use a smartphone and tolerate vaginal device insertion without pain.

Phase N/A

Interventions

Referral: Referral
Summary: Process of directing patients to appropriate care services; not a direct therapeutic mechanism. Source: NCI Thesaurus.
Procedure: Questionnaire Administration
Summary: Collects patient-reported outcomes on quality of life and symptoms; no biological mechanism, used for subjective data gathering. Source: NCI Thesaurus.
Device: Flyte Medical Device Usage and Evaluation
Summary: Non-invasive transvaginal mechanotherapy device stimulating pelvic floor muscle contraction to treat urinary incontinence. Source: Summary of Web Search.
Procedure: Interview
Summary: Qualitative method to gather patient experiences and feedback on treatment impact. Source: NCI Thesaurus.
Behavioral: Educational Intervention
Summary: Educational sessions and materials aimed at improving patient knowledge and disease-related behavior. Source: NCI Thesaurus.

Key Inclusion

Female with prior pelvic radiation for endometrial or cervical cancer ≥3 months prior
Age ≥21 years
English speaking
Diagnosis of urinary incontinence or overactive bladder
Able to contract pelvic floor muscles without pain
Able to tolerate size 6 vaginal dilator
Access to smartphone/tablet with internet
Willing to complete follow-up

Key Exclusion

Currently receiving active cancer-directed therapy post hysterectomy
Radiation or surgery completed within 3 months of enrollment
Life expectancy <6 months
Inability to tolerate intravaginal wand insertion
Suspected vesicovaginal or colovaginal fistula
Physical or cognitive limitations impeding device use
Acute infection or hematuria
Inability to contract pelvic floor muscles without pain