Bladder Cancer Clinical Trials Intelligence
Monthly Update Report for Trials Started in December 2025
Powered by Sophic Starlight
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is provided for educational and consulting purposes only. This report is not a substitute for professional medical advice, diagnosis, or treatment. Sophic shall not be held responsible for any interpretation, application, or use of this report beyond these purposes.
The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. Reports are provided entirely free of charge, and patients should never be billed or charged for access to this information. Users agree to reference Sophic in any publication, presentation, or publicity that incorporates or relies upon information from Sophic Starlight Cancer Clinical Trials Intelligence Reports.
1: Summary data from new trials identified for Bladder Cancer.
Overview
Number of Trials: 4
These four trials investigate novel treatment approaches for bladder cancer across different stages and molecular subtypes. One trial evaluates at-home administration of standard cancer therapies via remote monitoring. Two trials target advanced urothelial cancer: one testing intravesical MK-3120 in BCG-naïve or BCG-exposed non-muscle invasive disease, and another combining vepugratinib with enfortumab vedotin and pembrolizumab in FGFR3-altered metastatic disease. The fourth trial examines bladder preservation using trimodal therapy following neoadjuvant chemotherapy in muscle-invasive bladder cancer with variant histology.
Common Criteria Across Trials
Common Inclusion
- Age 18 years or older
- Histologically confirmed bladder cancer or urothelial carcinoma
- ECOG performance status 0-3
- Adequate organ function and laboratory parameters
- Written informed consent and ability to comply with study requirements
- Measurable or evaluable disease
Common Exclusion
- Active uncontrolled infection requiring systemic therapy
- Severe concurrent systemic illness or comorbidities
- History of other malignancies within specified timeframes
- Prior pelvic radiotherapy (for certain trials)
- Unresolved toxicities from prior therapy
- Active CNS metastases or leptomeningeal disease
- Investigational agent use for primary neoplasm
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT07218380 — Requires qualifying FGFR3 genetic alteration from tumor or blood sample obtained after diagnosis of advanced or metastatic disease
Unique or Unusual Criteria
- NCT07285044 — Requires residence in Florida Panhandle with Wi-Fi connectivity, social stability screening, and ability to manage remote monitoring technology or have consistent caregiver support
- NCT07222488 — Excludes severe dry eye syndrome, Meibomian gland disease, blepharitis, or corneal disease; includes specific BCG exposure timing criteria (naïve or recurrence 12-24 months post-BCG)
- NCT06417190 — Excludes diffuse carcinoma in situ and bilateral hydronephrosis; focuses specifically on variant histology muscle-invasive disease
- NCT07218380 — Excludes corneal keratopathy or retinal disorder confirmed by ocular examination; requires first-line treatment setting for metastatic disease
Trials with Emerging Treatments
- NCT07222488 — MK-3120 in BCG-Naïve or BCG-Exposed High-Risk NMIBC
Items: MK-3120 (SKB410)
Note: Anti-nectin-4 antibody-drug conjugate with topoisomerase I inhibitor payload for intravesical administration; targets nectin-4 overexpressed on bladder tumor cells with bystander effect capability - NCT07218380 — FORAGER-2: Vepugratinib in FGFR3-Altered Urothelial Carcinoma
Items: Vepugratinib
Note: FGFR3-targeted therapy tested in combination with enfortumab vedotin and pembrolizumab for first-line treatment of FGFR3-altered metastatic urothelial cancer; precision medicine approach - NCT06417190 — Bladder Preservation for MIBC With Variant Histology
Items: Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy
Note: Bladder-sparing approach combining TURBT, chemotherapy, and radiation for muscle-invasive disease with variant histology, a historically challenging subgroup
3: Individual Trial Overviews
NCT07285044
Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas
Organization/Sponsor: Mayo Clinic
Example patient: A 62-year-old man with metastatic bladder cancer receiving pembrolizumab infusions, ECOG PS 1, living in the Florida Panhandle with Wi-Fi access and planning to continue treatment for at least 12 weeks.
Phase 2
NCT07285044
Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas
Organization/Sponsor: Mayo Clinic
Example patient: A 62-year-old man with metastatic bladder cancer receiving pembrolizumab infusions, ECOG PS 1, living in the Florida Panhandle with Wi-Fi access and planning to continue treatment for at least 12 weeks.
Interventions
-
Procedure: Questionnaire Administration
Summary: Administration of questionnaires to assess patient outcomes and experiences during at-home cancer therapy delivery (NCI Thesaurus). -
Procedure: Cancer Therapeutic Procedure
Summary: Standard-of-care cancer treatment interventions including immunotherapy, chemotherapy, hormonal therapy, and supportive care agents administered at home versus clinic (NCI Thesaurus).
Key Inclusion
- Histologically confirmed malignancy receiving standard-of-care treatment
- Age >= 18 years
- ECOG performance status 0-3
- Adequate tolerability of current treatment regimen
- Resides in Florida Panhandle with Wi-Fi access
- Receiving eligible regimens including immunotherapy, chemotherapy, or hormonal agents
- Plan to continue treatment for >= 12 weeks
- Eligible cancer types include bladder, breast, colorectal, lung, prostate, and others
Key Exclusion
- Co-morbid systemic illnesses interfering with safety assessment
- Receiving investigational agents for primary neoplasm
- Requires continuous 24/7 assistance without available caregiver support
- Current inpatient hospitalization
NCT07222488
Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer
Organization/Sponsor: Merck Sharp & Dohme LLC
Example patient: A 68-year-old with BCG-exposed high-risk carcinoma in situ who completed adequate BCG therapy 18 months ago, underwent complete TURBT 8 weeks ago, has no cardiovascular disease, and can hold bladder voiding for 2 hours.
Phase 1, Phase 2
NCT07222488
Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer
Organization/Sponsor: Merck Sharp & Dohme LLC
Example patient: A 68-year-old with BCG-exposed high-risk carcinoma in situ who completed adequate BCG therapy 18 months ago, underwent complete TURBT 8 weeks ago, has no cardiovascular disease, and can hold bladder voiding for 2 hours.
Interventions
-
Drug: MK-3120
Summary: An antibody-drug conjugate targeting nectin-4, a tumor-associated antigen overexpressed in various cancers. The monoclonal antibody binds nectin-4 on tumor cells, internalizes, and releases a topoisomerase I inhibitor that blocks DNA replication, causing cell cycle arrest and apoptosis. It also induces a bystander effect on neighboring tumor cells. Source: NCI Thesaurus.
Key Inclusion
- Histologically confirmed carcinoma in situ with or without papillary high-risk NMIBC
- Most recent TURBT performed within 12 weeks before allocation
- BCG-naïve or BCG-exposed with recurrence >12 months but ≤24 months after last BCG dose
- Complete TURBT for papillary tumors (Ta and T1)
- HIV-infected participants with well-controlled HIV on antiretroviral therapy eligible
- Hepatitis B surface antigen positive eligible if on HBV antiviral therapy ≥4 weeks with undetectable viral load
- History of HCV infection eligible if viral load undetectable at screening
Key Exclusion
- History of or current locally advanced (T2, T3, T4) or metastatic urothelial cancer
- Concurrent extravesical non-muscle invasive UC or history with recurrence within last 2 years
- Active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture
- Uncontrolled significant cardiovascular or cerebrovascular disease within 6 months
- Severe dry eye syndrome, Meibomian gland disease, blepharitis, or severe corneal disease
- Known additional malignancy requiring active treatment within past 3 years
- History of noninfectious pneumonitis or interstitial lung disease requiring steroids
- Not adequately recovered from major surgery or has ongoing surgical complications
NCT06417190
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
Organization/Sponsor: Cedars-Sinai Medical Center
Example patient: A 68-year-old patient with newly diagnosed cT3N0M0 muscle-invasive bladder cancer with variant histology confirmed by TURBT and CT scan, no prior pelvic radiation, unilateral hydronephrosis, and no concurrent malignancies.
Phase N/A
NCT06417190
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
Organization/Sponsor: Cedars-Sinai Medical Center
Example patient: A 68-year-old patient with newly diagnosed cT3N0M0 muscle-invasive bladder cancer with variant histology confirmed by TURBT and CT scan, no prior pelvic radiation, unilateral hydronephrosis, and no concurrent malignancies.
Interventions
-
Combination: Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)
Summary: Trimodal therapy combines transurethral resection, chemotherapy, and radiation therapy to preserve the bladder while treating muscle-invasive cancer, administered within 45 days of neoadjuvant chemotherapy. Source: Web Search.
Key Inclusion
- Documented diagnosis of MIBC with variant histology
- cT2-T4N0M0 stage
- Confirmed by TURBT
- Confirmed by CT C/A/P and/or PET
- Written informed consent obtained
- Ability to comply with study requirements
Key Exclusion
- Evidence of diffuse carcinoma in situ on pathology
- Presence of bilateral hydronephrosis
- Prior radiotherapy to the pelvis
- History of systemic therapy for MIBC
- Presence of concurrent cancer
- Cancer history within 5 years unless without evidence of disease
NCT07218380
FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration Genomic-based
Organization/Sponsor: Eli Lilly and Company
Example patient: A 68-year-old with newly diagnosed metastatic urothelial bladder cancer harboring an FGFR3 mutation, ECOG performance status 1, with measurable lung metastases, no prior systemic therapy for metastatic disease, and normal ocular examination.
Phase 3
NCT07218380
FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration Genomic-based
Organization/Sponsor: Eli Lilly and Company
Example patient: A 68-year-old with newly diagnosed metastatic urothelial bladder cancer harboring an FGFR3 mutation, ECOG performance status 1, with measurable lung metastases, no prior systemic therapy for metastatic disease, and normal ocular examination.
Interventions
-
Drug: Vepugratinib
Summary: Vepugratinib is an FGFR3-targeted agent designed to inhibit FGFR3 mutations in bladder cancer, being tested in combination with enfortumab vedotin and pembrolizumab for advanced urothelial cancer with FGFR3 alterations (Web Search). -
Biological: Pembrolizumab
Summary: Pembrolizumab is a humanized IgG4 monoclonal antibody that blocks PD-1 receptor, enhancing T-cell-mediated immune responses against tumors; FDA-approved for multiple solid and hematologic malignancies including urothelial cancer (FDA label, NCI Thesaurus). -
Drug: Enfortumab Vedotin
Summary: Enfortumab vedotin (EV) is an antibody-drug conjugate targeting Nectin-4 for treatment of urothelial carcinoma; note: provided description appears erroneous referencing skin disorder rather than drug mechanism. -
Other: Placebo
Summary: Placebo is an inactive compound identical in appearance to the active treatment, used to distinguish drug action from suggestive effects in controlled experimental research (NCI Thesaurus).
Key Inclusion
- Histologically confirmed unresectable locally advanced or metastatic urothelial cancer
- Qualifying FGFR3 genetic alteration determined via molecular testing
- Measurable disease by RECIST v1.1
- ECOG performance status 0 to 2
- Adequate laboratory parameters
- Mixed histology eligible if urothelial component present
Key Exclusion
- Prior systemic therapy for locally advanced or metastatic urothelial cancer
- Unresolved toxicities greater than Grade 1 from prior neoadjuvant or adjuvant therapy
- Ongoing sensory or motor neuropathy Grade 2 or higher
- Untreated or uncontrolled CNS involvement or leptomeningeal disease
- Current corneal keratopathy or retinal disorder confirmed at screening
- Small cell or neuroendocrine carcinoma histology