Clinical Trials for Bladder Cancer

FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations

Active drug

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

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.

TrialFetch AI summary: Patients with locally advanced or metastatic urothelial cancer or other advanced solid tumors are enrolled in cohorts with varying FGFR3-alteration and prior-treatment requirements. Treatment is oral LOXO-435, an investigational FGFR3 inhibitor, alone or combined with pembrolizumab, with or without enfortumab vedotin.

ClinicalTrials.gov ID: NCT05614739

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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

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.

TrialFetch 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 Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue Metastases

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

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.

TrialFetch 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

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.

TrialFetch 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 II Multicenter Study of Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

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.

TrialFetch AI summary: Adults with measurable locally advanced/metastatic rare non-urothelial GU malignancies (pure urinary-tract adenocarcinoma or squamous cell carcinoma) or treatment-refractory testicular germ cell tumors (ECOG 0–1; germ cell tumors must have exhausted curative options) receive enfortumab vedotin, a nectin-4–directed antibody–drug conjugate delivering MMAE (microtubule-disrupting payload), either alone (D1/8/15 q28d) or—if checkpoint inhibitor–naïve—in combination with pembrolizumab (anti–PD-1) (EV D1/8 + pembrolizumab D1 q21d). Prior PD-1/PD-L1 therapy is allowed in separate cohorts, but prior EV/MMAE-ADC exposure is excluded.

ClinicalTrials.gov ID: NCT06041503

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients 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.

TrialFetch AI summary: Adults with measurable, advanced unresectable or metastatic solid tumors and no suitable curative treatment receive intratumoral or intravenous VET3-TGI, alone or with pembrolizumab. VET3-TGI is an oncolytic vaccinia virus engineered to express CXCR3 and IL-12 and inhibit TGF-β to promote tumor killing and antitumor immunity.

ClinicalTrials.gov ID: NCT06444815