Bladder Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in March 2026

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

Overview

Number of Trials: 5

These five trials investigate treatments for urothelial and bladder cancers, including muscle-invasive and non-muscle invasive disease. Four trials focus on advanced or metastatic urothelial cancer using novel targeted therapies (PF-08634404, IDE892, IDE397) and immunotherapies (enfortumab vedotin, pembrolizumab, cemiplimab, fianlimab), often in combination. One trial evaluates bladder preservation with neoadjuvant stereotactic radiotherapy plus immunotherapy for cisplatin-ineligible patients. Another trial tests a digital exercise intervention for non-muscle invasive bladder cancer patients on surveillance. Common themes include targeting specific molecular alterations (MTAP deletion, Nectin-4), immune checkpoint inhibition, and improving quality of life.

Common Criteria Across Trials

Common Inclusion

Age ≥18 years
ECOG performance status 0-1 or 0-2
Histologically confirmed urothelial or bladder cancer
Measurable disease or confirmed disease stage
Adequate organ function (hematologic, hepatic, renal)
Life expectancy ≥3-12 weeks
Willingness to provide informed consent and comply with study procedures
Effective contraception for participants of childbearing potential

Common Exclusion

Active or uncontrolled CNS metastases
Active autoimmune disease requiring systemic treatment within past 2 years
History of another malignancy within 2-3 years
Participation in another investigational study within 30 days or specified timeframe
Pregnant or breastfeeding
Uncontrolled infection or serious medical conditions
Prior systemic therapy within specified washout periods
Immunosuppressive therapy exceeding 10 mg prednisone equivalent daily
Known HIV, hepatitis B, or hepatitis C (unless controlled)
History of pneumonitis or interstitial lung disease

Outcomes Summary

Primary Outcomes

Safety and tolerability (adverse events, dose-limiting toxicities) (3 trials)
Antitumor activity (objective response rate, disease control rate) (2 trials)
Bladder preservation rate (1 trials)
Physical activity levels and quality of life (1 trials)

Secondary Outcomes

Pharmacokinetics parameters (2 trials)
Progression-free survival (2 trials)
Overall survival (2 trials)
Duration of response (2 trials)
Patient-reported outcomes and quality of life (2 trials)

2: Extracted Trials with New Information

Trials with Special Criteria

Genomic / Biomarker Trials

NCT07277413 — Requires homozygous loss or deletion of MTAP confirmed by central testing
NCT07475806 — Requires predominant urothelial histology (≥50%); excludes neuroendocrine histology and plasmacytoid variant

Unique or Unusual Criteria

NCT07302230 — Requires insufficiently active status on Physical Activity as a Vital Sign assessment and access to Android or iOS smartphone/tablet
NCT07414992 — Specifically for cisplatin-ineligible or cisplatin-declining patients; requires troponin levels ≤2x ULN and excludes history of myocarditis
NCT07277413 — Excludes use of proton pump inhibitors within 7 days and drugs with QT prolongation risk within 2 weeks

Trials with Emerging Treatments

NCT07421700 — AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER
Items: PF-08634404
Note: Novel investigational agent with no FDA approval; mechanism not specified in available data
NCT07277413 — A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors
Items: IDE892, IDE397
Note: IDE892 is a PRMT5 inhibitor and IDE397 is a MAT2A inhibitor, both targeting synthetic lethality in MTAP-deleted cancers; no FDA approval
NCT07414992 — Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)
Items: Fianlimab
Note: Fianlimab targets TIM-3 immune checkpoint pathway; investigational agent without FDA approval, used in combination with cemiplimab and SBRT

3: Individual Trial Overviews

NCT07421700

AN INTERVENTIONAL PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER

Organization/Sponsor: Pfizer

Example patient: A 62-year-old with ECOG status 1 and metastatic urothelial carcinoma with measurable lung lesions, adequate organ function, no CNS metastases, and no autoimmune disease requiring treatment.

Phase 1b, Phase 2

Interventions

Drug: Enfortumab Vedotin
Summary: Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4, a cell surface protein expressed on urothelial cancer cells, delivering cytotoxic agent monomethyl auristatin E to induce tumor cell death.
Drug: PF-08634404
Summary: PF-08634404 is an investigational agent being evaluated as monotherapy or in combination with enfortumab vedotin for locally advanced or metastatic urothelial carcinoma.

Key Inclusion

Age ≥18 years
Histologically confirmed locally advanced or metastatic urothelial carcinoma
Measurable disease per RECIST v1.1
ECOG performance status 0 or 1
Adequate organ function including hematologic, hepatic, and renal parameters

Key Exclusion

History of another malignancy within 3 years or residual disease from prior malignancy
Known active CNS lesions including leptomeningeal, brainstem, meningeal, or spinal cord metastases
Active autoimmune diseases requiring systemic treatment within past 2 years
Participation in another investigational study within 30 days or 5 half-lives
Pregnant or breastfeeding

NCT07475806

An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin Plus Pembrolizumab for Bladder Preservation in Participants With Muscle-invasive Bladder Cancer (EV-209)

Organization/Sponsor: Astellas Pharma Inc

Example patient: A 62-year-old with ECOG status 1, newly diagnosed cT3N0M0 muscle-invasive bladder cancer with predominant urothelial histology, eligible for cystectomy, no prior systemic therapy or autoimmune disease, and recent TURBT performed.

Phase 2

Interventions

BLA: Pembrolizumab
Summary: Pembrolizumab is a humanized monoclonal IgG4 antibody that blocks PD-1 receptor on T cells, preventing binding of PD-L1 and PD-L2, thereby enhancing immune-mediated tumor destruction. FDA-approved for multiple cancers including melanoma, NSCLC, and head and neck cancers. Source: FDA label, NCI Thesaurus.
BLA: Enfortumab Vedotin
Summary: Enfortumab vedotin is a Nectin-4-directed antibody-drug conjugate delivering monomethyl auristatin E (MMAE), a microtubule-disrupting agent, to induce apoptosis in Nectin-4-overexpressing urothelial cancer cells. FDA-approved for locally advanced or metastatic urothelial cancer. Source: FDA label, NCI Thesaurus.

Key Inclusion

Histologically-confirmed MIBC, stage cT2-T4aN0M0 or T1-T4aN1M0
Predominant urothelial carcinoma histology (≥50%)
Eligible for radical cystectomy and pelvic lymph node dissection
Accessible archival tumor tissue or willingness to undergo biopsy
ECOG performance status 0 to 2
Transurethral resection of bladder tumor within 60 days (+14 days) prior to screening

Key Exclusion

Preexisting sensory or motor neuropathy Grade ≥2
≥N2 disease or metastatic disease (M1)
Uncontrolled diabetes mellitus (HbA1c ≥8% or 7-8% with symptoms)
Prior anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
Prior systemic anti-cancer therapy for MIBC/NMIBC within 3 years
History of pneumonitis/ILD requiring steroids or current pneumonitis
Active autoimmune disease requiring systemic treatment in past 2 years
Prior radiotherapy to the bladder or partial cystectomy

NCT07302230

The EMPOWER Trial: Evaluating a Home-Based Physical Activity Program (PAP) With the ExerciseRx™ Digital Platform vs. Health Education Group (HEG) in People With Non-Muscle Invasive Bladder Cancer

Organization/Sponsor: University of Washington

Example patient: A 62-year-old English-speaking ambulatory adult with non-muscle invasive bladder cancer on intravesical BCG maintenance therapy, classified as insufficiently active, owns a smartphone, and is willing to participate in a home-based exercise program.

Phase N/A

Interventions

Procedure: Electronic Health Record Review
Summary: Analyzing patient data from electronic health records to assess outcomes and inform care decisions (NCI Thesaurus).
Procedure: Interview
Summary: Qualitative method gathering patient-reported experiences, preferences, and treatment impacts through structured conversations (NCI Thesaurus).
Procedure: Questionnaire Administration
Summary: Collection of patient self-reported outcomes assessing quality of life, psychological and physical impacts of treatment (NCI Thesaurus).
Behavioral: Educational Intervention
Summary: Educational activities using lectures, brochures, and multimedia to improve knowledge and address lifestyle changes in disease management (NCI Thesaurus).
Procedure: Health Telemonitoring
Summary: Remote monitoring of patient health status using digital telecommunication tools for real-time data collection and communication (NCI Thesaurus).
Behavioral: Exercise Intervention
Summary: Managed physical activity program targeting cancer-related fatigue and quality of life improvement through modulation of tumor microenvironment (NCI Thesaurus).
Other: Best Practice
Summary: Informed treatment recommendation expected to benefit the greatest number of patients within a specific group (NCI Thesaurus).
Behavioral: Internet-Based Intervention
Summary: Digital program using internet platforms to promote health behaviors, targeting physical activity and mental well-being (NCI Thesaurus).

Key Inclusion

Adults age 18 years or older
Prior diagnosis of non-muscle invasive bladder cancer
Currently on surveillance or receiving maintenance intravesical therapy
Classified as insufficiently active on PAVS assessment
Has Android or Apple smartphone/tablet
Ambulatory
English-speaking
Willing to participate and sign informed consent

Key Exclusion

Severe cognitive or memory impairment/dementia
Lack of access to Android or iOS smart device
Not receiving treatment at University of Washington
Orthopedic, neurologic, or other problems preventing safe ambulation
Unwillingness to participate in personalized exercise program
Current diagnosis with muscle-invasive or metastatic bladder cancer
Uncontrolled or concurrent illness limiting compliance
Participation in conflicting clinical trial

NCT07277413

A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors Genomic-based

Organization/Sponsor: IDEAYA Biosciences

Example patient: A 62-year-old with metastatic MTAP-deleted NSCLC adenocarcinoma, ECOG PS 1, who progressed after platinum chemotherapy and pembrolizumab, with adequate organ function and no brain metastases.

Phase N/A

Interventions

Drug: IDE892
Summary: IDE892 is a PRMT5 inhibitor that targets MTAP-deleted tumors by exploiting synthetic lethality in cancers lacking methylthioadenosine phosphorylase (Summary of Web Search).
Drug: IDE397
Summary: IDE397 is an oral MAT2A inhibitor that blocks S-adenosyl-L-methionine production, inhibiting proliferation in MTAP-deleted cancers dependent on SAM synthesis (NCI Thesaurus, Summary of Web Search).

Key Inclusion

Age ≥18 years
Histologically confirmed locally advanced recurrent or metastatic solid tumor with MTAP deletion
Homozygous loss of MTAP or MTAP deletion confirmed
At least 1 measurable lesion per RECIST v1.1
ECOG Performance Status 0 or 1
Life expectancy >3 months
Adequate bone marrow and organ function
NSCLC progressed after platinum chemotherapy and PD-1/PD-L1 inhibitor

Key Exclusion

Symptomatic brain metastases requiring supraphysiologic corticosteroids
Known primary CNS malignancy
Other malignancies within 2 years
Uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks
Severe infections within 4 weeks prior to treatment
Positive HIV test at screening
Previous treatment with MAT2A or PRMT inhibitor
Use of proton pump inhibitors within 7 days prior to first dose

NCT07414992

Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)

Organization/Sponsor: Memorial Sloan Kettering Cancer Center

Example patient: A 67-year-old man with ECOG 1, cT3N0M0 urothelial bladder cancer, creatinine clearance 45 ml/min making him cisplatin-ineligible, who is a surgical candidate for radical cystectomy without metastatic disease or autoimmune conditions.

Phase N/A

Interventions

Procedure: Radical cystectomy
Summary: Surgical removal of the entire bladder, urethra portion, adjacent lymph nodes, and additional genitourinary structures including prostate in men and uterus/ovaries in women (NCI Thesaurus).
Drug: Cemiplimab
Summary: Human monoclonal antibody targeting PD-1 that blocks interaction with PD-L1/PD-L2, restoring immune function and activating cytotoxic T-cells against tumors; FDA-approved for cutaneous squamous cell carcinoma, basal cell carcinoma, and NSCLC (FDA label, NCI Thesaurus).
Drug: Fianlimab
Summary: Immunotherapy targeting TIM-3 pathway to enhance immune response against cancer cells, under investigation in bladder cancer trials (Web Search Summary).
Radiation: Stereotactic body radiotherapy
Summary: High-dose radiation delivered in few sessions targeting localized bladder cancer, potentially enhancing immune response with minimal side effects (Web Search Summary).

Key Inclusion

Age ≥18 years, ECOG 0-1
Histologically confirmed urothelial carcinoma with predominant urothelial component
cT2-4a cN0 cM0 muscle-invasive bladder cancer
Declines or ineligible for cisplatin (creatinine clearance 30-60 ml/min, Grade 2+ hearing loss, or Grade 2+ neuropathy)
Medically appropriate candidate for radical cystectomy
Tumor specimen block or 20 unstained slides available
Adequate organ function and hematologic parameters
Life expectancy ≥12 weeks

Key Exclusion

Evidence of metastatic disease or nodal metastasis (cN+)
Prior systemic chemotherapy or non-BCG immunotherapy for bladder cancer
Prior pelvic radiotherapy
Active autoimmune disease requiring systemic immunosuppression within 2 years
Immunosuppressive corticosteroids (≥10 mg/day prednisone equivalent)
Live vaccine within 30 days or during treatment
History of myocarditis or troponin >2x ULN
Uncontrolled HIV, HBV, or HCV infection; pregnancy or breastfeeding