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
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
Nogapendekin alfa inbakicept-pmln (IL‑15 superagonist) + BCG tops pembrolizumab (PD‑1) on 12‑mo CR in BCG‑unresponsive NMIBC CIS (MAIC)
Nogapendekin alfa inbakicept-pmln (NAI; an IL‑15 superagonist cytokine complex that expands/activates NK and CD8+ T cells) plus intravesical BCG from the Phase 3 QUILT‑3.032 trial (NCT03022825) was compared vs…
NCT03022825 - Trial result
Bladder and urothelial cancer
Durvalumab (PD-L1) + ddMVAC Hits ~49% pCR in Neoadjuvant MIBC; Tremelimumab (CTLA-4) Adds Toxicity
NEMIO (Phase I/II, randomized, noncomparative; NCT03549715) tested ddMVAC plus durvalumab with or without tremelimumab ahead of radical cystectomy in cisplatin-eligible cT2–T4a N0–1 muscle-invasive bladder cancer…
NCT03549715 - Trial result Spotlight
Bladder and urothelial cancer
EV-103: Enfortumab vedotin (Nectin-4 ADC) + pembrolizumab (PD-1) sustains 41.5% 5-year survival in 1L cisplatin-ineligible la/mUC
Enfortumab vedotin is a Nectin-4–directed antibody–drug conjugate delivering MMAE, combined here with pembrolizumab (anti–PD-1) as first-line therapy in EV-103 dose escalation/cohort A (Phase Ib/II; NCT03288545) for…
NCT03288545 - New trial Spotlight
Bladder and urothelial cancer
Phase 3 EV-309 tests enfortumab vedotin Nectin-4 ADC + pembrolizumab PD-1 inhibitor
This Phase 3, open-label, randomized, multicenter study (EV-309) evaluates bladder-preserving enfortumab vedotin plus pembrolizumab versus concurrent chemoradiotherapy (cCRT) in adults with non-metastatic…
NCT07566156 Registrational - New trial
Bladder and urothelial cancer
Phase 1/2 REINFORCE tests enfortumab vedotin Nectin-4 ADC + pembrolizumab PD-1 blockade with consolidation
University of Washington’s Phase 1/2 REINFORCE pilot asks whether patients with unresectable locally advanced, node-positive, or oligometastatic muscle-invasive bladder cancer who achieve a favorable response (CR/PR)…
NCT07579195 Exploratory - New trial
Bladder and urothelial cancer
Phase 2 gemcitabine + Jelmyto mitomycin (DNA crosslinker) chemoablation in high-grade UTUC
Rutgers (Rutgers Cancer Institute of New Jersey) is running this Phase 2, kidney-sparing, single-arm study testing sequential endoluminal gemcitabine and Jelmyto (mitomycin gel) delivered into the affected collecting…
NCT06822010 Exploratory - New trial Spotlight
Bladder and urothelial cancer
Phase 2 enfortumab vedotin Nectin-4 ADC + pembrolizumab PD-1 inhibitor for bladder preservation.
This open-label, single-arm Phase 2 EV-209 study tests whether continuing enfortumab vedotin plus pembrolizumab can enable durable response and bladder-intact survival (including bladder intact at 2 years) in…
NCT07475806 Exploratory - Trial result
Bladder and urothelial cancer
BT5528 (EphA2-targeted Bicycle Drug Conjugate delivering MMAE) + nivolumab shows 30% ORR in EphA2+ post–checkpoint mUC
BT5528 is a low–molecular weight EphA2-targeting Bicycle Drug Conjugate (BDC) linked to the microtubule toxin MMAE via a cleavable linker; here it was combined with nivolumab (anti–PD-1) in a Phase 1/2…
NCT04180371 - New trial Spotlight
Bladder and urothelial cancer
Phase 2/3 Izalontamab Brengitecan EGFR/HER3 bispecific ADC in metastatic urothelial cancer
This study, sponsored by Bristol-Myers Squibb and conducted at multiple international sites, is evaluating a novel ADC targeting EGFR/HER3 (BMS-986507) against standard platinum-based chemotherapy (cisplatin,…
NCT07106762 Registrational - Trial result Spotlight
Bladder and urothelial cancer
TAR-200 Intravesical Gemcitabine Device Posts 82% CR in BCG-Unresponsive CIS (Phase IIb)
TAR-200 is an osmotic intravesical drug-releasing system for sustained gemcitabine delivery; in SunRISe-1, BCG-unresponsive high-risk NMIBC received TAR-200 alone, TAR-200+cetrelimab (PD-1), or cetrelimab alone…
- New trial
Bladder and urothelial cancer
Phase II: Therapeutic plasma exchange + enfortumab vedotin (Nectin-4 ADC) + pembrolizumab vs standard therapy in metastatic urothelial/upper-tract cancer
This randomized Mayo Clinic study tests whether a TPE lead-in before enfortumab vedotin plus pembrolizumab improves outcomes versus standard next-line therapy in patients with metastatic, refractory urothelial or…
NCT07087860 Exploratory - New trial
Bladder and urothelial cancer
Phase III trial: Gemcitabine DNA synthesis inhibitor plus intravesical BCG for recurrent bladder cancer
This randomized Phase III trial, sponsored by Alliance for Clinical Trials in Oncology and conducted at multiple US sites, evaluates whether adding gemcitabine—a ribonucleotide reductase inhibitor that blocks DNA…
NCT07000084 Registrational - New trial
Bladder and urothelial cancer
Phase II Study Enfortumab Vedotin (Nectin-4 ADC) Consolidative Surgery in Locally Advanced Urothelial Carcinoma
This phase II trial evaluates consolidative extirpative surgery for patients with locally advanced or oligo-metastatic urothelial carcinoma who achieved disease control with enfortumab vedotin-based systemic therapy.…
NCT07048457 Exploratory - New trial
Bladder and urothelial cancer
Phase II study: Gemcitabine (ribonucleotide reductase inhibitor) and Carboplatin (platinum inhibitor) in urothelial carcinoma
This Phase II trial at Fox Chase Cancer Center evaluates the efficacy and safety of gemcitabine plus carboplatin in patients with advanced urothelial carcinoma who have progressed following enfortumab vedotin and…
NCT07043972 Exploratory - New trial
Bladder and urothelial cancer
Phase 1/2 Trial of Nadofaragene Firadenovec, IFN-alpha2b Expressing Adenovirus Gene Therapy
This open-label, single-arm study led by Ferring Pharmaceuticals evaluates safety and tolerability of nadofaragene firadenovec in adult patients with low-grade upper tract urothelial carcinoma, including papillary…
NCT06668493 Exploratory - New trial
Bladder and urothelial cancer
Phase 1 Trial of CA-4948 (IRAK4/FLT3 inhibitor) with Pembrolizumab
This Phase 1 study led by the National Cancer Institute assesses safety, tolerability, optimal dosing, and early efficacy of oral CA-4948 combined with intravenous pembrolizumab in patients with metastatic urothelial…
NCT06439836 Exploratory - New trial
Bladder and urothelial cancer
Phase 2 TYRA-300 FGFR3-directed mAb trial
This open-label study at Nashville evaluates TYRA-300 monotherapy in patients with FGFR3-altered, low grade, intermediate risk non-muscle invasive bladder cancer. The trial features dose-finding cohorts sponsored by…
NCT06995677 Exploratory - New trial
Bladder and urothelial cancer
Phase 2 study V940 personalized mRNA vaccine for patient-specific cancer immune targeting
This Phase 2 study evaluates whether combining V940 with standard BCG extends event-free survival compared to BCG alone, as well as the efficacy of V940 monotherapy in high-risk non-muscle invasive bladder cancer.…
NCT06833073 Exploratory - Trial result
Bladder and urothelial cancer
Detalimogene voraplasmid (EG-70) non-viral IL-12/RIG-I gene therapy achieves 73% complete response in BCG-unresponsive NMIBC, Phase 2 LEGEND trial now enrolling broader cohorts
Detalimogene voraplasmid is an intravesical, non-integrating plasmid that co-expresses IL-12 and a RIG-I agonist to trigger local innate and adaptive immunity. In the Phase 1 dose-escalation of the open-label LEGEND…
NCT04752722 - Trial result
Bladder and urothelial cancer
Zelenectide Pevedotin (Nectin-4 BTC) + Pembrolizumab Delivers 65% ORR (25% CR) in First-Line Cisplatin-Ineligible Urothelial Cancer
Zelenectide pevedotin is a “Bicycle” toxin conjugate that targets Nectin-4 and releases MMAE. When combined with a PD-1 blockade, it aims to rapidly induce cytotoxicity while also priming the immune system. In…
NCT04561362 - Trial result
Bladder and urothelial cancer
Avelumab + Docetaxel Scores 52% ORR in Platinum-Refractory or -Ineligible mUrothelial Carcinoma
In the single-arm Phase 1b AVETAX trial (NCT03575013), 21 patients with metastatic urothelial carcinoma who were either platinum-refractory (n=8) or cisplatin-ineligible (n=13) received docetaxel plus avelumab,…
NCT03575013 - Trial result
Bladder and urothelial cancer
Avelumab (anti-PD-L1) plus ddMVAC nets 58% pCR pre-cystectomy and 87% 3-yr OS in muscle-invasive bladder cancer
Phase 2 AURA trial (NCT03674424) enrolled 137 non-metastatic MIBC patients slated for radical cystectomy: cisplatin-eligible cases got neoadjuvant avelumab with either ddMVAC (n = 38) or gem-cis (n = 36), while…
NCT03674424 - New trial
Bladder and urothelial cancer
Phase II Trial of Herpes Virus T3011 Injection (IL‑12 & PD‑1 Mab) in High-Risk NMIBC
ImmVira Pharma is spearheading a phase II study to assess the tolerability, safety, and early efficacy of T3011—an oncolytic HSV‑1 engineered to express IL‑12 and a PD‑1 monoclonal antibody—in patients with…
NCT06971614 - New trial
Bladder and urothelial cancer
HERO Trial: Phase I Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents in Localized Bladder Cancer
This trial explores a neoadjuvant combo of intravesical romidepsin and durvalumab in cisplatin-ineligible, muscle-invasive bladder cancer patients, testing escalating doses of the HDAC inhibitor to boost…
NCT06963346 - New trial
Bladder and urothelial cancer
Phase 1/2 Study of Intravesical Sacituzumab Tirumotecan in Intermediate-risk NMIBC
Merck is launching an open-label study to assess the safety, tolerability, and optimal dosing of intravesically administered Sacituzumab Tirumotecan in participants with intermediate-risk, low-grade, recurrent NMIBC.…
NCT06637423 - Trial result
Bladder and urothelial cancer
Atezolizumab Combined with Personalized Neoantigen Vaccine Shows Feasibility in Urothelial Cancer
In this phase 1 trial, 10 out of 12 enrolled urothelial cancer patients successfully received the personalized neoantigen vaccine PGV001 alongside atezolizumab, with a median vaccine production time of 20.3 weeks.…
- New trial
Bladder and urothelial cancer
Phase II Study: 5-ALA–Enhanced Fluorescence for Upper Tract Urothelial Cancer Detection
Henry Ford Health System is evaluating whether a single oral dose of 5-ALA given 2–4 hours preoperatively improves the visibility of upper tract urothelial tumors via blue light fluorescence during ureteroscopic…
NCT06948552
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