Bladder Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in May 2026

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

Overview

Number of Trials: 3

These three trials explore novel treatment strategies for advanced solid tumors, with two focused on muscle-invasive bladder cancer (MIBC) and one on DLL3-expressing cancers including small cell lung cancer. NCT07566156 evaluates enfortumab vedotin plus pembrolizumab with chemoradiotherapy for cisplatin-ineligible MIBC patients choosing bladder preservation. NCT07414992 tests stereotactic body radiotherapy (SBRT) combined with cemiplimab with or without fianlimab as neoadjuvant therapy before cystectomy in cisplatin-ineligible or declining MIBC patients. NCT07278479 investigates a novel radioligand therapy, [212Pb]Pb-DOTAM-MAM279, targeting DLL3-positive tumors including small cell lung cancer and neuroendocrine carcinomas. All trials target patients who have exhausted or are ineligible for standard therapies, emphasizing immunotherapy combinations and innovative targeted approaches.

Common Criteria Across Trials

Common Inclusion

Age ≥18 years
Histologically or cytologically confirmed diagnosis
ECOG performance status 0-2
Adequate bone marrow function (ANC ≥1.0-1.5 × 10^9/L, platelets ≥100 × 10^9/L)
Adequate hepatic function
Adequate renal function (creatinine clearance ≥30-60 mL/min or GFR >60 mL/min)
Measurable disease by imaging
Life expectancy ≥12 weeks
Contraception requirements for women of childbearing potential and male patients

Common Exclusion

Metastatic disease (for bladder cancer trials)
Prior pelvic radiation therapy
Active autoimmune disease requiring systemic immunosuppression within 2 years
Immunosuppressive doses of corticosteroids (≥10 mg prednisone equivalent daily)
Live vaccine within 30 days of treatment
History of allogeneic transplant
Active uncontrolled infections (HIV, hepatitis B/C unless controlled)
Other active malignancy within 2-3 years
Major surgery within 4 weeks
Significant cardiac disease (NYHA Grade II or greater CHF, recent MI or stroke)
Pregnancy or breastfeeding
History of pneumonitis or interstitial lung disease

2: Extracted Trials with New Information

Trials with Special Criteria

Genomic / Biomarker Trials

NCT07278479 — Requires DLL3-positivity confirmed by [203Pb]Pb-DOTAM-MAM279 SPECT/CT imaging for epNECs and SCLC/LC NECs in Part 2

Unique or Unusual Criteria

NCT07566156 — Requires patients to be ineligible for or elect not to undergo cystectomy, choosing bladder preservation with chemoradiotherapy
NCT07414992 — Excludes patients with troponin T/I >2x ULN and history of myocarditis due to cardiac safety concerns with immunotherapy
NCT07566156 — Excludes patients with active keratitis or corneal ulcerations, likely due to enfortumab vedotin ocular toxicity
NCT07278479 — Allows patients with stable CNS metastases and prior DLL3-targeted therapy

Trials with Emerging Treatments

NCT07278479 — A Phase 1/2a Study to Assess Safety, Tolerability, and Efficacy of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors
Items: [212Pb]Pb-MP0712, [203Pb]Pb-MP0712
Note: Novel alpha-particle radioligand therapy targeting DLL3-expressing tumors; uses lead-212 isotope for targeted radiation delivery to cancer cells
NCT07414992 — NeoSTAR Bladder
Items: Cemiplimab and Fianlimab combination
Note: Combination of PD-1 inhibitor (cemiplimab) with LAG-3 inhibitor (fianlimab) plus SBRT as neoadjuvant therapy; dual checkpoint blockade approach
NCT07566156 — Enfortumab Vedotin + Pembrolizumab for MIBC
Items: Enfortumab vedotin
Note: Nectin-4-directed antibody-drug conjugate delivering MMAE cytotoxic payload, combined with pembrolizumab and chemoradiotherapy for bladder preservation

3: Individual Trial Overviews

NCT07566156

A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY

Organization/Sponsor: Astellas Pharma Inc

Example patient: A 68-year-old male with newly diagnosed cT3N0M0 muscle-invasive urothelial bladder cancer, ECOG performance status 1, who is medically fit but declines cystectomy and opts for bladder-preserving chemoradiotherapy.

Phase 3

Interventions

Drug: Pembrolizumab
Summary: Humanized monoclonal IgG4 antibody blocking PD-1 receptor, enhancing T-cell immune responses against tumor cells; FDA-approved for multiple cancers including melanoma and lung cancer (FDA label, NCI Thesaurus).
Drug: Gemcitabine
Summary: Nucleoside analog inhibiting DNA synthesis by incorporating into DNA and inhibiting ribonucleotide reductase; indicated for pancreatic, lung, breast, and ovarian cancers (FDA label, NCI Thesaurus).
Drug: Mitomycin C
Summary: Antibiotic-derived alkylating agent producing DNA cross-links and oxygen radicals, preferentially toxic to hypoxic cells; used for gastric and pancreatic adenocarcinomas (FDA label, NCI Thesaurus).
Drug: Fluorouracil
Summary: Fluoropyrimidine antimetabolite inhibiting thymidylate synthase and incorporating into RNA/DNA, disrupting nucleic acid synthesis; indicated for colon, rectal, breast, stomach, and pancreatic cancers (FDA label, NCI Thesaurus).
Drug: Cisplatin
Summary: Platinum-based alkylating agent forming DNA cross-links and inducing apoptosis; indicated for testicular, ovarian, and bladder cancers with nephrotoxicity and ototoxicity risks (FDA label, NCI Thesaurus).
Radiation: Hypofractionated Radiotherapy
Summary: Radiation therapy delivering higher doses per session to reduce treatment duration while maintaining effectiveness in bladder cancer (Web Search Summary).
Radiation: Conventional Radiotherapy
Summary: Standard radiation therapy using high-energy beams to target and destroy bladder cancer cells, aiming to shrink tumors (Web Search Summary).
Drug: Enfortumab vedotin
Summary: Nectin-4-directed antibody-drug conjugate delivering MMAE microtubule inhibitor to cancer cells; FDA-approved for locally advanced or metastatic urothelial cancer alone or with pembrolizumab (FDA label, NCI Thesaurus).

Key Inclusion

Histologically confirmed muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0
Eligible for and agree to receive chemoradiotherapy with protocol-specified radiosensitizing chemotherapy
Fit for systemic therapy and elect bladder preservation
Ineligible for or have elected not to undergo cystectomy
ECOG performance status of 0, 1, or 2

Key Exclusion

Advanced or metastatic disease (N+, M1) or non-urothelial carcinoma
Prior systemic treatment, chemoradiation, or radiation for MIBC or NMIBC
Prior pelvic radiation for any reason
Previously treated with enfortumab vedotin, MMAE-based ADCs, or PD(L)-1 inhibitors
Active malignancies within 3 years prior to randomization
Active infection requiring systemic antimicrobial treatment at randomization
Known active hepatitis B, hepatitis C, or HIV infection
History of autoimmune disease requiring systemic treatment in past 2 years

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 68-year-old man with ECOG 1, cT3N0M0 urothelial bladder cancer, creatinine clearance of 45 ml/min making him cisplatin-ineligible, no prior chemotherapy or pelvic radiation, and medically fit for radical cystectomy.

Phase N/A

Interventions

Procedure: Radical cystectomy
Summary: Radical cystectomy removes the bladder and nearby lymph nodes to treat muscle-invasive bladder cancer, aiming to eliminate cancer and prevent recurrence (Summary of Web Search).
Drug: Cemiplimab and Fianlimab
Summary: Cemiplimab and Fianlimab are immunotherapies targeting PD-1 and TIM-3 pathways to enhance immune response against bladder cancer cells in clinical trials (Summary of Web Search).
Biological: Cemiplimab
Summary: Cemiplimab is a PD-1 blocking monoclonal antibody that binds PD-1, preventing interaction with PD-L1/PD-L2, thereby restoring immune function and activating cytotoxic T-cells against tumors (FDA label, NCI Thesaurus).
Radiation: Stereotactic body radiotherapy
Summary: SBRT delivers high-dose radiation in few sessions to localized bladder cancer, potentially enhancing immune response while adjusting to anatomic changes during treatment (Summary of Web Search, NCI Thesaurus).

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 laboratory values
Women of childbearing potential must use contraception

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 doses of corticosteroids (≥10 mg/day prednisone equivalent)
Live vaccine within 30 days of study start
History of myocarditis or troponin >2x ULN
Uncontrolled HIV, HBV, or HCV infection

NCT07278479

A Phase 1/2a Study to Assess Safety, Tolerability, and Efficacy of [212Pb]Pb-DOTAM-MAM279 in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors Genomic-based

Organization/Sponsor: Molecular Partners AG

Example patient: A 62-year-old patient with histologically confirmed bladder neuroendocrine carcinoma showing DLL3 positivity on SPECT/CT imaging, with disease progression after one prior platinum-based chemotherapy regimen, adequate organ function, and no active cardiac disease.

Phase 1, Phase 2

Interventions

Radioligand Therapy: [203Pb]Pb-MP0712
Summary: Diagnostic radioligand targeting DLL3-expressing cancer cells, delivering lead-203 radiation for imaging to identify patients suitable for therapy via SPECT/CT scanning (Summary of Web Search).
Radioligand Therapy: [212Pb]Pb-MP0712
Summary: Therapeutic radioligand targeting DLL3 receptors on cancer cells, delivering alpha-particle radiation via lead-212 to induce tumor cell death in lung cancer and other solid tumors (Summary of Web Search).

Key Inclusion

Age ≥18 years old
Histologically or cytologically confirmed advanced SCLC, LC NECs, or epNECs including bladder NECs
Progression or recurrence following at least one prior line of systemic therapy
DLL3-positivity by [203Pb]Pb-DOTAM-MAM279 SPECT/CT for epNECs and Part 2 patients
At least one measurable disease per RECIST v1.1
Adequate bone marrow reserve: hemoglobin ≥9 g/dL, ANC ≥1.5×10^9/L, platelets ≥100×10^9/L
Adequate renal function: calculated GFR >60 mL/min
Clinically stable CNS metastases allowed

Key Exclusion

Uncontrolled intercurrent illness
Clinically significant toxic effects from prior therapy not resolved to Grade ≤1
Active clinically significant cardiac disease
Evidence of interstitial lung disease or active non-infectious pneumonitis
History of other malignancy within past 2 years with exceptions