Clinical Trials for Bladder Cancer

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: Adults with metastatic urothelial carcinoma who progressed after anti–PD-(L)1 therapy and are eligible for platinum receive the ADC izalontamab brengitecan (targets a tumor-associated antigen and delivers a topoisomerase I inhibitor payload) versus physician’s choice cisplatin/gemcitabine or carboplatin/gemcitabine. Key exclusions include recent platinum (≤12 months), >2 prior systemic regimens, prior EGFR/HER3 ADCs or topo I inhibitors, and untreated brain mets.

ClinicalTrials.gov ID: NCT07106762

A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors

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: This trial enrolls adults with advanced solid tumors who have exhausted standard treatment options, testing the investigational single-agent ACTM-838 (mechanism of action not specified) as monotherapy. Eligible patients must have measurable disease, good performance status, adequate organ function, and CD4 counts >500/mL.

ClinicalTrials.gov ID: NCT06336148

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic, immunologically cold solid tumors—including biliary tract, HR-negative/HER2-positive breast, platinum-resistant ovarian, pancreatic adenocarcinoma, soft tissue sarcoma, castrate-resistant prostate, neuroendocrine, and vulvar cancers—who have progressed on or are intolerant to standard therapies. Patients receive atezolizumab (anti-PD-L1 immune checkpoint inhibitor) combined with tivozanib (oral VEGFR tyrosine kinase inhibitor), aiming to improve tumor response rates in this refractory population.

ClinicalTrials.gov ID: NCT05000294

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: This trial enrolls adults with locally advanced, unresectable, or metastatic HER2-expressing solid tumors (excluding breast, gastric, and colorectal), including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare tumors, who have progressed after prior therapy or lack alternative options. All patients receive trastuzumab deruxtecan, a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor to HER2-expressing tumor cells.

ClinicalTrials.gov ID: NCT04482309

RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3

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 relapsed/refractory DLL3-expressing or DLL3-prevalent tumors (including SCLC, LCNEC, high-grade neuroendocrine tumors, and select NSCLC/other histologies) receive the DLL3-directed bispecific T‑cell engager tarlatamab plus external-beam radiation, given concurrently or sequentially depending on safety. Key risks include CRS/ICANS; includes extracranial and cranial RT cohorts with allowance for treated/stable brain mets and selected brain lesions.

ClinicalTrials.gov ID: NCT06814496

A Multicenter, Single-Arm Open Label Phase II Trial of Cryoablation in Combination With Pembrolizumab or Avelumab in Patients With Metastatic Urothelial Carcinoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Adults with metastatic (stage IV) urothelial carcinoma (bladder/upper tract/urethra), ECOG 0–1, checkpoint inhibitor–naïve, with at least one lesion amenable to percutaneous cryoablation and separate measurable disease, receive pembrolizumab (PD-1 inhibitor) every 3 weeks or avelumab (PD-L1 inhibitor) every 2 weeks plus a single CT-guided cryoablation between cycles 1 and 2. Aims to assess systemic responses in non-ablated lesions; key exclusions include prior ICI, significant autoimmune disease/immunosuppression, and ablation contraindications.

ClinicalTrials.gov ID: NCT04701918

A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Adults with metastatic urothelial carcinoma who progressed after enfortumab vedotin and PD‑1/PD‑L1 therapy (or are ineligible for PD‑1/PD‑L1) are randomized to eribulin plus gemcitabine versus physician’s choice single‑agent chemotherapy (docetaxel, gemcitabine, or paclitaxel). Eribulin is a microtubule dynamics inhibitor (halichondrin B analog) partnered with gemcitabine to test for survival benefit in this refractory setting.

ClinicalTrials.gov ID: NCT04579224

A Phase II Study of Olaparib (AZD2281) in Patients With Metastatic/Advanced Urothelial Carcinoma and Other Genitourinary Tumors With DNA-Repair Defects

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Biomarker-selected adults with metastatic/advanced non‑prostate genitourinary cancers (e.g., urothelial) harboring DNA‑repair defects (BRCA1/2, ATM, PALB2, CHEK2, MMR, POLE/POLD1, or TMB ≥10) after prior platinum and/or checkpoint inhibitor receive olaparib, an oral PARP1/2 inhibitor exploiting homologous recombination deficiency. Patients without qualifying DDR alterations are observed without study drug.

ClinicalTrials.gov ID: NCT03375307

Randomized Phase II Rescuing Cancer Immunotherapy With Plasma Exchange in Bladder Cancer 1 (ReCIPE-B1)

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 that progressed after prior enfortumab vedotin plus pembrolizumab are randomized to re-challenge with enfortumab vedotin (nectin-4–targeting ADC delivering MMAE) plus pembrolizumab (PD-1 inhibitor) with added therapeutic plasma exchange (days 1–3 of cycles 1–3) versus physician’s choice next-line standard of care. Eligible patients have measurable disease and ECOG 0–2; key exclusions include variant histologies (neuroendocrine, micropapillary, signet ring) and significant comorbidity.

ClinicalTrials.gov ID: NCT07087860

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other 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: This trial involves patients with advanced or metastatic solid tumors expressing Nectin-4, including urothelial carcinoma, triple-negative breast cancer, non-small cell lung cancer, and ovarian cancer, who have exhausted standard therapy options. It evaluates LY4052031, an antibody-drug conjugate that targets Nectin-4 to deliver a topoisomerase I inhibitor, aiming to assess its safety, tolerability, and efficacy in these patients.

ClinicalTrials.gov ID: NCT06465069