Clinical Trials for Bladder Cancer

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

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 solid tumors (including HNSCC, NSCLC, colorectal, TNBC, RCC, and acral melanoma) that are refractory or resistant to standard therapies, testing the investigational HLA-G antagonist monoclonal antibody TTX-080 alone or combined with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. Control arms include standard regimens for comparison in metastatic colorectal cancer.

ClinicalTrials.gov ID: NCT04485013

A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer

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 or unresectable rare non‑prostate GU cancers (high‑grade neuroendocrine, primary adenocarcinoma [urachal/non‑urachal], squamous cell of bladder/urinary tract, renal medullary carcinoma, or penile SCC) receive sacituzumab govitecan, with addition of atezolizumab for checkpoint inhibitor–naive patients. Sacituzumab govitecan is a Trop‑2–targeted antibody–drug conjugate delivering SN‑38 (topoisomerase I inhibitor), and atezolizumab is a PD‑L1 inhibitor.

ClinicalTrials.gov ID: NCT06161532

A Phase II Study of Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

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 small cell carcinoma of the bladder or other high‑grade neuroendocrine tumors of the urinary tract (including mixed histology), with measurable progressive disease after, ineligible for, or refusing platinum/etoposide (ECOG 0–2), receive lurbinectedin IV q21d; ICI‑naive, ICI‑eligible patients may also receive avelumab. Lurbinectedin is a selective transcription inhibitor; avelumab is a PD‑L1–blocking antibody.

ClinicalTrials.gov ID: NCT06228066

Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)

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 GI cancers (esophagus/GEJ/gastric, small bowel, colorectal/appendiceal, biliary, HCC, pancreatic/ampullary) on a benefiting systemic regimen who develop up to 5 new/progressing lesions receive lesion-directed local ablation (SABR or IR ablation) while continuing the same systemic therapy. Aims to control oligoprogression and delay systemic therapy change; excludes contraindications to ablation or active brain progression.

ClinicalTrials.gov ID: NCT06101277

Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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 advanced solid tumors (e.g., NSCLC, melanoma, RCC, urothelial, HNSCC, MSI-H/dMMR cancers, TNBC, HCC, gastric/GEJ, cervical, anal, Merkel cell) who have at least stable disease after ~12 months of PD-1/PD-L1 therapy (pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab) are randomized to discontinue therapy versus continue until progression. Compares de-escalation after 1 year to ongoing checkpoint blockade to evaluate disease control, time to next treatment, and safety.

ClinicalTrials.gov ID: NCT04157985

A Phase I Study of Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

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 non‑prostate genitourinary cancers (e.g., urothelial, renal cell, germ cell) receive bintrafusp alfa (anti–PD‑L1/TGF‑β trap) plus PDS01ADC/NHS‑IL12 (tumor‑targeted IL‑12 immunocytokine), with or without SBRT to up to four lesions, to assess safety and dosing. Prior systemic therapy and checkpoint inhibitors are allowed; SBRT cohorts require at least one irradiable lesion and one non‑irradiated measurable lesion.

ClinicalTrials.gov ID: NCT04235777

A Phase II Trial to Evaluate Pemetrexed Response in Relation to Tumor Alterations of Gene Status in Patients With Previously Treated Metastatic Urothelial Carcinoma and Other Solid Tumors

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 or other solid tumors harboring loss-of-function alterations in KMT2D (MLL4), KDM6A (UTX), or MTAP receive pemetrexed every 21 days with standard vitamin/steroid supplementation. Pemetrexed is an antifolate chemotherapy inhibiting TS, DHFR, and GARFT, tested here in genomically selected tumors potentially sensitized via one‑carbon metabolism or PRMT5/MTAP axis vulnerabilities.

ClinicalTrials.gov ID: NCT06630416

CAST-AI: Cystectomy After Systemic Therapy With ADC and Immunotherapy

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 newly diagnosed, node-positive or metastatic urothelial carcinoma (bladder or upper tract), ECOG 0–2, receive first-line enfortumab vedotin (nectin‑4–targeting MMAE ADC) plus pembrolizumab (PD‑1 inhibitor) for at least 4 cycles, then proceed to cytoreductive cystectomy and/or ureterectomy if surgical candidates, with optional metastasis-directed therapy and potential postoperative maintenance EV/pembrolizumab. Excludes prior systemic therapy or checkpoint inhibitor exposure, significant comorbidities/autoimmunity, and prior pelvic RT.

ClinicalTrials.gov ID: NCT06764095

Phase II Single-Arm Study of Enfortumab Vedotin (EV) Plus Pembrolizumab in the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

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 unresectable locally advanced or metastatic bladder cancers of variant or non-urothelial epithelial histologies (e.g., micropapillary, plasmacytoid, sarcomatoid, squamous, adenocarcinoma/urachal), ECOG 0–1, treatment-naïve or previously treated, excluding prior EV or PD-1/L1 therapy. Treatment is enfortumab vedotin (Nectin-4–targeting antibody–drug conjugate delivering MMAE) plus pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT05756569

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