Bladder Cancer Clinical Trials Intelligence
Monthly Update Report for Trials Started in February 2026
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: 5
These five trials span diverse approaches to cancer treatment and management. Two trials (NCT07277413, NCT07337525) test novel targeted therapies for advanced solid tumors: IDE892/IDE397 for MTAP-deleted cancers and PLT012 targeting CD36. One trial (NCT07232602) evaluates combination immunotherapy with enfortumab vedotin plus pembrolizumab in urothelial carcinoma. Another trial (NCT07227077) focuses on physical activity interventions for older cancer survivors with chronic pain. The final trial (NCT07474519) assesses patient positioning and BCG dwell time in non-muscle invasive bladder cancer treatment.
Common Criteria Across Trials
Common Inclusion
- Age 18 years or older
- Histologically or cytologically confirmed cancer diagnosis
- ECOG performance status 0 or 1
- Adequate organ function and bone marrow function
- Life expectancy greater than 3 months
- Measurable disease per RECIST v1.1
- Willingness to provide informed consent
- Ability to provide tissue samples for biomarker testing
Common Exclusion
- Active or symptomatic brain metastases or CNS malignancy
- Other active malignancies within 2 years
- Uncontrolled HIV, hepatitis B, or hepatitis C infection
- Active autoimmune disease requiring systemic treatment
- Severe or uncontrolled cardiovascular disease
- Active infection requiring systemic therapy
- History of organ or stem cell transplant
- Insufficient washout from prior therapies
- Ongoing Grade 2 or higher toxicities from prior treatment
- Pregnancy or breastfeeding
Outcomes Summary
Primary Outcomes
- Safety and tolerability (adverse events, dose-limiting toxicities) (3 trials)
- Pharmacokinetics and pharmacodynamics (2 trials)
- Objective response rate or efficacy per RECIST v1.1 (3 trials)
- Physical activity levels and adherence (1 trials)
- BCG dwell time and patient positioning effects (1 trials)
Secondary Outcomes
- Duration of response and progression-free survival (3 trials)
- Overall survival (2 trials)
- Quality of life and patient-reported outcomes (2 trials)
- Biomarker analysis and correlative studies (3 trials)
2: Extracted Trials with New Information
Trials with Special Criteria
Genomic / Biomarker Trials
- NCT07277413 — Requires homozygous MTAP deletion or MTAP loss confirmed by central testing
- NCT07232602 — Requires tumor tissue sample for biomarker analysis; PD-L1 expression relevant for pembrolizumab
Unique or Unusual Criteria
- NCT07227077 — Requires smartphone access and willingness to wear fitness tracker; excludes metastatic or recurrent disease
- NCT07474519 — Requires ability to remain supine or sitting for two hours; excludes urinary incontinence with OAB score 3 or higher
- NCT07232602 — Excludes severe dry eye syndrome, Meibomian gland disease, corneal disease, and active inflammatory bowel disease
- NCT07277413 — Excludes prior treatment with MAT2A or PRMT inhibitors; restricts use of proton pump inhibitors and drugs affecting CYP3A4/5
Trials with Emerging Treatments
- 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 tumors. Phase 1 trials began in Q4 2025. - NCT07337525 — A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors
Items: PLT012
Note: PLT012 is a monoclonal antibody targeting CD36 to restore antitumor immunity by blocking CD36-mediated metabolic reprogramming in advanced solid tumors. - NCT07232602 — A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D
Items: MK-3120
Note: MK-3120 is an investigational agent being tested in combination with enfortumab vedotin and pembrolizumab for first-line urothelial carcinoma treatment.
3: Individual Trial Overviews
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 two prior lines including platinum-doublet chemotherapy and pembrolizumab, with measurable lung lesions and adequate organ function.
Phase N/A
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 two prior lines including platinum-doublet chemotherapy and pembrolizumab, with measurable lung lesions and adequate organ function.
Interventions
-
Drug: IDE397
Summary: IDE397 is a MAT2A inhibitor being studied in combination with Trodelvy for MTAP-deletion bladder cancer, targeting two distinct pathways. Clinical trials are ongoing to assess efficacy and safety (Source: Web Search). -
Drug: IDE892
Summary: IDE892 is a PRMT5 inhibitor targeting MTAP-deleted tumors, exploiting synthetic lethality in cancers with MTAP deletion. Phase 1 trials began in Q4 2025 (Source: 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
- NSCLC progressed after platinum chemotherapy and PD-1/PD-L1 inhibitor
- No more than 3 prior lines including no more than 2 chemotherapy lines
Key Exclusion
- Symptomatic brain metastases requiring supraphysiologic corticosteroids
- Known primary CNS malignancy
- Other malignancies within 2 years
- Impaired cardiac function or clinically significant cardiac diseases
- Severe infections within 4 weeks prior to treatment
- Uncontrolled hypertension >150/100 mmHg
- Positive HIV test or known viral hepatitis
- Prior treatment with MAT2A or PRMT inhibitor
NCT07227077
An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial
Organization/Sponsor: Medical College of Wisconsin
Example patient: A 68-year-old English-speaking woman with a history of treated early-stage breast cancer without recurrence or metastasis, who owns a smartphone and experiences chronic pain.
Phase N/A
NCT07227077
An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial
Organization/Sponsor: Medical College of Wisconsin
Example patient: A 68-year-old English-speaking woman with a history of treated early-stage breast cancer without recurrence or metastasis, who owns a smartphone and experiences chronic pain.
Interventions
-
Behavioral: Physical Activity Promotion Intervention
Summary: A free-living physical activity intervention using pedometers or activity trackers to reduce sedentary behavior and increase exercise, targeting behavior change to improve fatigue, functional ability, muscle strength, quality of life, and health outcomes in cancer survivors (NCI Thesaurus, Web Search).
Key Inclusion
- Age greater than or equal to 65 years
- History of bladder, breast, cervical, colorectal, endometrial, lung, or prostate cancer diagnosis and treatment
- Fluent in spoken and written English
- Access to smartphone
- Ability to understand and sign written informed consent
Key Exclusion
- Metastatic disease
- Cancer recurrence
NCT07232602
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D
Organization/Sponsor: Merck Sharp & Dohme LLC
Example patient: A 68-year-old man with newly diagnosed metastatic urothelial carcinoma, no prior systemic therapy, controlled hypertension, and available archival tumor tissue from recent biopsy.
Phase 1, Phase 2
NCT07232602
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D
Organization/Sponsor: Merck Sharp & Dohme LLC
Example patient: A 68-year-old man with newly diagnosed metastatic urothelial carcinoma, no prior systemic therapy, controlled hypertension, and available archival tumor tissue from recent biopsy.
Interventions
-
Drug: Pembrolizumab
Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor, preventing binding to PD-L1/PD-L2, thereby activating T-cell-mediated immune responses against tumor cells; FDA-approved for multiple cancers including urothelial carcinoma (FDA label, NCI Thesaurus). -
Drug: Enfortumab Vedotin
Summary: Antibody-drug conjugate targeting Nectin-4 that delivers cytotoxic agent to cancer cells; approved for advanced bladder cancer, improving survival in locally advanced or metastatic urothelial carcinoma (Web Search Summary). -
Drug: MK-3120
Summary: Investigational agent being studied for high-risk non-muscle invasive bladder cancer; mechanism of action not publicly disclosed; evaluated for safety and efficacy in clinical trials (Web Search Summary). -
Other: Rescue Medication
Summary: Supportive medication for managing treatment-related adverse events; may include agents targeting PD-1/PD-L1 pathways or other symptom management therapies (Web Search Summary).
Key Inclusion
- Histologically documented urothelial carcinoma that is locally advanced and unresectable or metastatic
- Must provide newly obtained or archival tumor tissue sample (core or excisional biopsy)
- No prior systemic therapy for locally advanced or metastatic UC
- HIV-positive patients with well controlled HIV on antiretroviral therapy eligible
- Hepatitis B surface antigen positive patients with undetectable HBV viral load after 4+ weeks antiviral therapy
- Hepatitis C virus history with undetectable HCV viral load before randomization
Key Exclusion
- History of severe dry eye syndrome, Meibomian gland disease, blepharitis, or corneal disease preventing healing
- Active inflammatory bowel disease requiring immunosuppression or history of IBD
- Uncontrolled cardiovascular or cerebrovascular disease within 6 months
- Active autoimmune disease requiring systemic treatment in past 2 years
- Known active CNS metastases or carcinomatous meningitis
- History of pneumonitis/interstitial lung disease requiring steroids or current pneumonitis
- Active infection requiring systemic therapy
- History of stem cell or solid organ transplant
NCT07474519
An Assessment of Patient Position and Intravesical BCG Dwell Time
Organization/Sponsor: Ohio State University Comprehensive Cancer Center
Example patient: A 68-year-old with newly diagnosed high-risk non-muscle invasive bladder cancer who can maintain supine and sitting positions for two hours and agrees to wear a fitness tracker during BCG induction therapy.
Phase N/A
NCT07474519
An Assessment of Patient Position and Intravesical BCG Dwell Time
Organization/Sponsor: Ohio State University Comprehensive Cancer Center
Example patient: A 68-year-old with newly diagnosed high-risk non-muscle invasive bladder cancer who can maintain supine and sitting positions for two hours and agrees to wear a fitness tracker during BCG induction therapy.
Interventions
-
Biological: BCG Solution
Summary: Live attenuated Mycobacterium bovis vaccine administered intravesically to treat non-muscle invasive bladder cancer by stimulating local immune responses and inflammatory reactions against tumor cells, reducing recurrence rates (FDA label, NCI Thesaurus). -
Behavioral: Accelerometry
Summary: Technique using wearable fitness trackers to quantify patient movement and physical activity levels during BCG treatment protocol (NCI Thesaurus). -
Other: Survey Administration
Summary: Collection of self-reported patient data via questionnaires to assess experiences, symptoms, and treatment outcomes (NCI Thesaurus). -
Other: Electronic Health Record Review
Summary: Analysis of patient electronic health data to assess treatment patterns, outcomes, and clinical characteristics (NCI Thesaurus). -
Other: Patient Discharge
Summary: Release of patient from treatment facility following BCG administration (NCI Thesaurus).
Key Inclusion
- Intermediate or high risk non-muscle invasive bladder cancer (NMIBC)
- Opting for intravesical induction BCG therapy
- Has not initiated induction therapy
- Able to remain supine for two hours
- Able to remain sitting for two hours
- Willingness to wear fitness tracker for at least five days
- Able to perform remote video or telephone encounter
Key Exclusion
- Receipt of intravesical BCG within past 1 year
- Known inability to retain BCG
- History of urinary incontinence with OAB score 3 or more
- Refusal to wear fitness tracker during baseline, treatment, or post-treatment periods
NCT07337525
A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors
Organization/Sponsor: Pilatus Biosciences Inc
Example patient: A 62-year-old patient with metastatic bladder cancer and ECOG performance status 1, measurable lung metastases, adequate organ function, and no active autoimmune disease or recent other malignancies.
Phase 1
NCT07337525
A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors
Organization/Sponsor: Pilatus Biosciences Inc
Example patient: A 62-year-old patient with metastatic bladder cancer and ECOG performance status 1, measurable lung metastases, adequate organ function, and no active autoimmune disease or recent other malignancies.
Interventions
-
Biological: PLT012
Summary: PLT012 is a monoclonal antibody targeting CD36 that aims to restore antitumor immunity by blocking CD36-mediated metabolic reprogramming in advanced solid tumors including bladder cancer (Source: Web Search).
Key Inclusion
- Aged at least 18 years
- Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies)
- At least one measurable lesion per RECIST v1.1
- ECOG PS of 0 to 1
- Life expectancy of ≥ 12 weeks
- Adequate organ function per protocol
- Child-Pugh score Class A (for hepatocellular carcinoma only)
Key Exclusion
- Insufficient washout period from prior therapies
- Ongoing Grade 2 or higher toxicities from prior treatments
- Concurrent or recent (within 2 years) malignancy
- Uncontrolled HIV, hepatitis B, or acute hepatitis C infections
- Unstable/uncontrolled or untreated CNS metastasis
- Active or recent (within 3 years) autoimmune disease requiring treatment
- Recipient of organ transplant including allogeneic stem-cell transplant
- Clinically significant and active cardiovascular disease