Clinical Trials for Bladder Cancer

Phase 1, Open-Label, Multicenter, First-In-Human Trial of Ds-2243a in Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with HLA-A2–positive advanced solid tumors (synovial sarcoma, myxoid/round cell liposarcoma, NSCLC adenocarcinoma/squamous, or urothelial carcinoma) after appropriate prior therapy receive subcutaneous DS-2243a, a bispecific T‑cell engager targeting CD3 and the HLA‑A*02/NY‑ESO‑1 peptide complex, with step-up dosing. Includes dose escalation and tumor-specific expansion; excludes prior NY‑ESO‑1–targeted therapy and requires measurable disease and ECOG 0–1.

ClinicalTrials.gov ID: NCT06644755

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Enrolling adults with metastatic rare genitourinary cancers across multiple histologic cohorts (e.g., small cell/neuroendocrine bladder, variant urothelial, penile, sarcomatoid/unclassified RCC, collecting duct, renal medullary, urethral; including a bone-only GU cohort), with up to two prior lines allowed (cohort-specific exceptions. Patients receive cabozantinib (MET/VEGFR2/AXL multi-kinase inhibitor) plus nivolumab (PD-1) and ipilimumab (CTLA-4) for up to 2 years.

ClinicalTrials.gov ID: NCT03866382

Phase Ib Trial of Erdafitinib Combined With Enfortumab Vedotin Following Platinum and PD1/L1 Inhibitors for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic Alterations

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with locally advanced/metastatic urothelial carcinoma harboring activating FGFR2/3 alterations after progression on platinum and a PD‑1/L1 inhibitor (including cisplatin-ineligible) receive erdafitinib (oral pan-FGFR1–4 TKI) plus enfortumab vedotin (Nectin‑4–targeted MMAE ADC). Requires measurable disease and adequate organ function; excludes prior FGFR inhibitors or enfortumab/MMAE ADCs and significant ocular/cardiovascular issues.

ClinicalTrials.gov ID: NCT04963153

A Phase I/Ib Open Label, Single-Arm Study of Cabozantinib in Combination with Enfortumab Vedotin (EV) in the Treatment of Locally Advanced or Metastatic Urothelial Cancer

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with unresectable locally advanced or metastatic urothelial carcinoma after prior PD-1/PD-L1 therapy (and prior platinum or platinum-ineligible), ECOG 0–2, receive enfortumab vedotin (anti–Nectin-4 ADC delivering MMAE) plus cabozantinib (multikinase inhibitor of MET/VEGFR/AXL) until progression/toxicity. Excludes prior EV/MMAE or cabozantinib, significant cardiovascular/GI risks, untreated/unstable CNS disease, and grade ≥2 neuropathy.

ClinicalTrials.gov ID: NCT04878029

An Open-Label, Multicenter, Phase 1/1b Study of RNDO-564 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Relapsed/Refractory Locally Advanced or Metastatic Urothelial Cancer and Other Solid Tumors Associated With Nectin-4 Expression

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with incurable, locally advanced/metastatic Nectin-4–positive solid tumors—emphasizing relapsed/refractory urothelial cancer—receive RNDO-564 weekly as monotherapy or combined with pembrolizumab every 3 weeks. RNDO-564 is a fully human CD28 × Nectin-4 costimulatory bispecific antibody intended to deliver localized CD28 T‑cell costimulation at Nectin-4–expressing tumors; early cohorts include multiple Nectin-4–associated cancers, with randomized dose-optimization in urothelial cancer.

ClinicalTrials.gov ID: NCT07218003

A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced/metastatic urothelial carcinoma or squamous cell carcinomas (lung, esophagus, cutaneous, head/neck, anogenital) after standard therapies receive single‑agent EVOLVE104, a trispecific T‑cell engager targeting ULBP2/5/6 with CD3 binding and CD2 costimulation. Open‑label dose escalation and expansion assess safety, PK, and preliminary efficacy, with treatment continued until progression or intolerance.

ClinicalTrials.gov ID: NCT07217171

A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced/metastatic solid tumors lacking effective standard options (broad basket with prioritized cohorts such as CRC, SCLC, HNSCC, NSCLC, pancreatic, and bladder; some genomically enriched) receive oral single‑agent CP-383 in dose escalation and tumor‑specific expansions. CP-383 is a first‑in‑class small molecule designed to modulate lipid‑binding pockets on oncogenic proteins (exact target undisclosed).

ClinicalTrials.gov ID: NCT07030257

A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced/metastatic urothelial/bladder cancer, NSCLC, HNSCC, esophageal cancer, or pancreatic adenocarcinoma (ECOG 0–1) receive PF-08046876, an ITGB6-targeted antibody–drug conjugate delivering a topoisomerase I payload, as IV monotherapy after prior standard therapy (≤2 prior lines in Part 2). Dose escalation/optimization and tumor-specific expansions assess safety, PK, and preliminary activity; excludes prior camptothecin/topo I ADC exposure and significant GI or pulmonary comorbidities.

ClinicalTrials.gov ID: NCT07090499

A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced solid tumors refractory to standard therapy (ECOG 0–1, measurable disease) receive a single intravenous infusion of IDOV-Immune (VM-002), a genetically engineered oncolytic vaccinia virus designed for tumor-selective replication and lysis with immune-stimulating transgenes to enhance antitumor immunity. Key exclusions include prior oncolytic virus therapy, recent vaccinia/smallpox vaccination, active autoimmune disease requiring systemic therapy, significant cardiopulmonary disease, uncontrolled infection, and unstable/untreated CNS metastases.

ClinicalTrials.gov ID: NCT06910657

Combinations of Sacituzumab Govitecan Plus Enfortumab Vedotin and Pembrolizumab for Metastatic Urothelial Carcinoma: the Double Antibody Drug Conjugate (DAD) and Double Antibody Drug Conjugate With Immunotherapy (DAD-IO) Phase I/II Trial

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with metastatic urothelial carcinoma: refractory cohort includes patients progressing after platinum (if eligible) and prior PD-1/L1 therapy; first-line cohort includes treatment‑naive mUC (prior perioperative therapy allowed, prior IO >6 months). Treatments are enfortumab vedotin (anti–Nectin-4 ADC with MMAE) plus sacituzumab govitecan (anti–Trop-2 ADC with SN‑38) for refractory disease, and the same doublet plus pembrolizumab (anti–PD‑1) for first line.

ClinicalTrials.gov ID: NCT04724018