Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in bladder and urothelial cancer
- Trial result Spotlight
Bladder and urothelial cancer
GemBCG (intravesical gemcitabine + BCG immunostimulation) delivers 96% 6‑mo CR in BCG-exposed high‑grade NMIBC
GemBCG combines intravesical gemcitabine (a DNA synthesis–inhibiting antimetabolite chemotherapy) with intravesical BCG (live-attenuated mycobacterial immunotherapy) in an alternating schedule to intensify local…
NCT04179162 - Trial result
Bladder and urothelial cancer
TAR-200 (intravesical gemcitabine device) vs nadofaragene firadenovec: no statistically significant CR durability difference detected through 24 months in BCG-unresponsive CIS
This reconstructed individual patient data (rIPD) cross-trial analysis digitized published Kaplan–Meier duration-of-response (DoR) curves among complete responders (CR-only) from SunRISe-1 Cohort 2 (TAR-200…
NCT02773849 - New trial
Bladder and urothelial cancer
Phase 2 FORAY tests selective FGFR3 inhibition with vepugratinib in low-grade bladder and upper tract urothelial tumors
FORAY is an Eli Lilly/Loxo Oncology Phase 2, randomized, open-label study of oral vepugratinib (LOXO-435; LY3866288), an isoform-selective FGFR3 tyrosine kinase inhibitor. Its two disease settings are low-grade,…
NCT07827612 Exploratory - New trial Spotlight
Bladder and urothelial cancer
Phase 2/3 Ivonescimab PD-1×VEGF bispecific antibody plus enfortumab vedotin Nectin-4 ADC in la/mUC
HARMONi-GU1 (NCT07815665) is a randomized, open-label, multicenter Phase 2/3 study testing whether ivonescimab + enfortumab vedotin (EV) can outperform pembrolizumab + EV as first-line therapy for unresectable…
NCT07815665 Registrational - New trial
Bladder and urothelial cancer
Phase 2 enfortumab vedotin Nectin-4 ADC (MMAE tubulin payload) plus pembrolizumab PD-1 antibody
University of Utah’s Phase 2 PRESERVE study tests whether systemic enfortumab vedotin (Padcev; Astellas Pharma + Pfizer)—a Nectin-4–targeted antibody–drug conjugate delivering MMAE, a microtubule inhibitor—combined…
NCT07822373 Exploratory - New trial
Bladder and urothelial cancer
Thermaclear heated-saline intravesical hyperthermia + gemcitabine (DNA synthesis inhibitor) in NMIBC
This prospective, randomized two-arm pilot study tests whether hyperthermic intravesical saline irrigation (42.0 ± 2°C) can be delivered safely and feasibly during TURBT for low- to intermediate-risk…
NCT07817173 Exploratory - New trial
Bladder and urothelial cancer
Phase 1b/2 capivasertib AKT (PKB) inhibitor plus immune checkpoint inhibitor in urothelial cancer
This VA Office of Research and Development Phase 1b/2 study tests whether adding capivasertib—an oral small‑molecule AKT (protein kinase B) inhibitor from AstraZeneca—to a patient’s ongoing immune checkpoint…
NCT07793578 Exploratory - New trial
Bladder and urothelial cancer
Phase 2 LUMBER-NAC compares neoadjuvant platinum chemotherapy (DNA crosslinking) vs upfront cystectomy
Rutgers University is running this Phase 2 randomized study in luminal-subtype muscle-invasive urothelial bladder cancer (cT2N0M0) to test whether skipping neoadjuvant systemic therapy is feasible and oncologically…
NCT07762586 Exploratory - Trial result
Bladder and urothelial cancer
pT3–4/pN+/pT2+LVI model flags ~4× higher post-cystectomy recurrence risk, guiding longer-intense surveillance
In a retrospective European individual-patient registry study of 3196 patients with cT2–T4 N0M0 bladder cancer treated with radical cystectomy across 16 centers (1990–2024), investigators used a Classification and…
- Trial result
Bladder and urothelial cancer
Erdafitinib (FGFR1–4 inhibitor) Extends OS vs Chemo in FGFR3‑Altered Metastatic Urothelial Cancer
Erdafitinib (Balversa) is an oral pan‑FGFR tyrosine kinase inhibitor targeting susceptible FGFR3 alterations and was evaluated in THOR/BLC3001 Cohort 1 (NCT03390504), an open‑label Phase 3 trial in previously treated…
NCT03390504 - Trial result Spotlight
Bladder and urothelial cancer
Cretostimogene grenadenorepvec (RB–E2F–selective oncolytic virus) drives 75% CR with near-zero severe toxicity in BCG-unresponsive CIS NMIBC
Cretostimogene grenadenorepvec is an intravesical, replication-competent oncolytic immunotherapy that preferentially replicates in and lyses tumor cells with retinoblastoma–E2F pathway alterations while also boosting…
NCT04452591 - Trial result Spotlight
Bladder and urothelial cancer
Enfortumab vedotin (Nectin-4 ADC) + pembrolizumab (PD-1) lifts EFS/OS vs cisplatin-gemcitabine in MIBC
Enfortumab vedotin is a Nectin-4–directed antibody–drug conjugate (MMAE payload) and pembrolizumab is a PD-1 inhibitor; in the Phase 3, open-label KEYNOTE-B15/EV-304 trial (NCT04700124), cisplatin-eligible…
NCT04700124 - Trial result Spotlight
Bladder and urothelial cancer
Enfortumab vedotin (Nectin-4 ADC) + pembrolizumab (PD-1) sustains 33.6-mo OS and high CR conversion vs platinum chemo in 1L la/mUC
Enfortumab vedotin is a Nectin-4–directed antibody–drug conjugate (MMAE payload) combined with pembrolizumab, a PD-1 inhibitor; in the randomized Phase 3 EV-302/KEYNOTE-A39 trial (NCT04223856), previously untreated…
NCT04223856 - Trial result
Bladder and urothelial cancer
PPM (PLZ4-targeted paclitaxel micelles) shows early complete remissions with clean safety in BCG-unresponsive NMIBC
PLZ4-coated paclitaxel-loaded micelles (PPM) are a solvent-free, intravesical nanoparticle designed to selectively bind bladder cancer cells (via the PLZ4 peptide) and deliver encapsulated paclitaxel for local…
NCT05519241 - Trial result
Bladder and urothelial cancer
Zelenectide pevedotin (BT8009) Nectin-4–targeted BDC + pembrolizumab hits 50% cORR and 13.0-mo mPFS in 1L cisplatin-ineligible la/mUC
Zelenectide pevedotin (zele; BT8009) is a Nectin-4–targeted Bicycle Drug Conjugate delivering MMAE (small 4.2 kDa construct with short plasma half-life), combined here with PD-1 blockade (pembrolizumab) in Duravelo-1…
NCT04561362 - New trial
Bladder and urothelial cancer
Phase 1b/2 quemliclustat CD73 adenosine-pathway inhibitor with EV nectin-4 ADC + pembro PD‑1
Fred Hutchinson Cancer Center is running a Phase 1b/2 study adding quemliclustat (a CD73 inhibitor that aims to reduce immunosuppressive adenosine signaling in the tumor microenvironment) to the now-established…
NCT07667335 Exploratory - Trial result Spotlight
Bladder and urothelial cancer
Ave + SG (TROP2 ADC) extends PFS across visceral/liver/bone subgroups vs avelumab alone in 1L maintenance aUC
Avelumab is a PD-L1 inhibitor, and sacituzumab govitecan (SG) is a TROP2-directed ADC delivering SN-38; this randomized Phase 2 JAVELIN Bladder Medley trial (NCT05327530) tested Ave + SG vs avelumab monotherapy as 1L…
NCT05327530 - Trial result
Bladder and urothelial cancer
Zelenectide pevedotin (BT8009) Nectin-4–targeted BDC + pembrolizumab hits 50% cORR and 13.0-mo mPFS in 1L cisplatin-ineligible la/mUC
Zelenectide pevedotin (zele; BT8009) is a Nectin-4–targeted Bicycle Drug Conjugate delivering MMAE (small 4.2 kDa construct with short plasma half-life), combined here with PD-1 blockade (pembrolizumab) in Duravelo-1…
NCT04561362 - Trial result
Bladder and urothelial cancer
Avelumab (PD-L1) 1L maintenance extends OS regardless of NECTIN4/HER2 RNA in la/mUC
Avelumab is an anti–PD-L1 monoclonal antibody used as first-line (1L) maintenance after platinum-based chemotherapy (PBC) in unresectable locally advanced/metastatic urothelial carcinoma (la/mUC). In the Phase 3…
NCT02603432 - Trial result
Bladder and urothelial cancer
Durvalumab (PD-L1) + tremelimumab (CTLA-4) neoadjuvant combo hits 44% pCR—but higher CTLA-4 dose triggers serious irAEs in cisplatin-ineligible MIBC
Durvalumab (anti–PD-L1) plus tremelimumab (anti–CTLA-4) was evaluated in a pilot neoadjuvant study for cisplatin-ineligible, high-risk muscle-invasive urothelial carcinoma (NCT02812420), with cystectomy planned 4–6…
NCT02812420 - Trial result
Bladder and urothelial cancer
Zelenectide pevedotin (BT8009) Nectin‑4 BDC + pembrolizumab delivers ~55–58% ORR in 1L la/mUC (Duravelo‑2 IA)
Zelenectide pevedotin (zele; BT8009) is a Nectin‑4–targeted Bicycle Drug Conjugate (BDC) evaluated with pembrolizumab in the Phase 2/3 Duravelo‑2 trial (NCT06225596; Cohort 1, previously untreated la/mUC; randomized…
NCT06225596 - Trial result
Bladder and urothelial cancer
LY4101174 (Nectin-4–targeted exatecan ADC) shows 18% ORR post-enfortumab vedotin in mUC—but with heavy hematologic toxicity
LY4101174 is a next-generation anti–Nectin-4 antibody-drug conjugate delivering the topoisomerase I inhibitor exatecan (DAR 8; maleimide–β-glucuronide poly-sarcosine linker) being evaluated in the EXCEED Phase 1…
NCT06238479 - Trial result
Bladder and urothelial cancer
LY4052031 (Nectin-4 topo1 ADC) delivers 48% ORR in metastatic urothelial cancer, including post-enfortumab activity
LY4052031 is a next-generation anti–Nectin-4 antibody-drug conjugate (ADC) with a cleavable linker and a novel topoisomerase I inhibitor payload (Camp98; DAR 8) evaluated in the NEXUS-01 Phase 1 dose-escalation study…
NCT06465069 - New trial
Bladder and urothelial cancer
Phase 3 STENT X compares ureteral stent device vs stent-free reconstruction (peri-anastomotic support)
Brigham and Women’s Hospital (Mass General Brigham) is running this Phase 3, prospective, randomized, multi-institution trial testing a very practical surgical question after radical cystectomy for bladder cancer:…
NCT07655284 Exploratory - Trial result Spotlight
Bladder and urothelial cancer
Ave + SG (TROP2 ADC) extends PFS across visceral/liver/bone subgroups vs avelumab alone in 1L maintenance aUC
Avelumab is a PD-L1 inhibitor, and sacituzumab govitecan (SG) is a TROP2-directed ADC delivering SN-38; this randomized Phase 2 JAVELIN Bladder Medley trial (NCT05327530) tested Ave + SG vs avelumab monotherapy as 1L…
NCT05327530 - Trial result Spotlight
Bladder and urothelial cancer
LY4052031 (Nectin-4 topo1 ADC) delivers 48% ORR in metastatic urothelial cancer, including post-enfortumab activity
LY4052031 is a next-generation anti–Nectin-4 antibody-drug conjugate (ADC) with a cleavable linker and a novel topoisomerase I inhibitor payload (Camp98; DAR 8) evaluated in the NEXUS-01 Phase 1 dose-escalation study…
NCT06465069 - Trial result Spotlight
Bladder and urothelial cancer
Enfortumab vedotin (Nectin-4 ADC) + pembrolizumab (PD-1) delivers ~57% pCR and halves death risk in cisplatin-ineligible MIBC
Enfortumab vedotin (a Nectin-4–directed MMAE antibody–drug conjugate) plus pembrolizumab (anti–PD-1) was evaluated as perioperative (neoadj-adj) therapy in the Phase 3 KEYNOTE-905/EV-303 randomized trial…
NCT03924895 - Trial result Spotlight
Bladder and urothelial cancer
Erdafitinib (pan-FGFR inhibitor) delivers 55% CR chemoablation in FGFR3-mutant recurrent NMIBC
Oral erdafitinib, a pan-FGFR1–4 tyrosine kinase inhibitor approved in metastatic urothelial carcinoma, was tested as short “chemoablation” in a Phase II window-of-opportunity study before TURBT in recurrent…
NCT04917809 - Trial result
Bladder and urothelial cancer
Zelenectide pevedotin (BT8009) Nectin-4–targeted BDC + pembrolizumab hits 50% cORR and 13.0-mo mPFS in 1L cisplatin-ineligible la/mUC
Zelenectide pevedotin (zele; BT8009) is a Nectin-4–targeted Bicycle Drug Conjugate delivering MMAE (small 4.2 kDa construct with short plasma half-life), combined here with PD-1 blockade (pembrolizumab) in Duravelo-1…
NCT04561362 - Trial result
Bladder and urothelial cancer
Avelumab (PD-L1) 1L maintenance extends OS regardless of NECTIN4/HER2 RNA in la/mUC
Avelumab is an anti–PD-L1 monoclonal antibody used as first-line (1L) maintenance after platinum-based chemotherapy (PBC) in unresectable locally advanced/metastatic urothelial carcinoma (la/mUC). In the Phase 3…
NCT02603432
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