Enfortumab Vedotin, Pembrolizumab, and Quemliclustat for Urothelial Cancer
This study is testing a combination of three drugs: Enfortumab Vedotin, Pembrolizumab, and Quemliclustat. It's for people with urothelial cancer (bladder, renal pelvis, or ureter cancer) that cannot be removed by surgery, has spread locally, or has spread to other parts of the body. Enfortumab Vedotin is a targeted drug that helps kill cancer cells, while Pembrolizumab is an immunotherapy that helps your immune system fight cancer. The study aims to find out if this combination is safe, what the best dose of Quemliclustat is, and how well it works. The study is looking for 27 participants and is currently unclear on its recruitment status. Success will be measured by how many people respond to the treatment and the number of side effects.
- Study design
- This is a Phase Ib/II study, meaning it will first look at safety and dosing, then how well the treatment works. It plans to enroll 27 participants.
- What's involved
- You would receive Quemliclustat, Enfortumab Vedotin, and Pembrolizumab intravenously (through a vein) every 21 days for up to 2 years. You would also have blood tests, CT scans, and MRI scans throughout the study, and may have a tumor biopsy.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed up within 30 days, and then every 12 weeks for 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07667335
Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~27 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:QuemliclustatBiospecimen CollectionComputed TomographyEnfortumab VedotinMagnetic Resonance ImagingPembrolizumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment related adverse events (Phase Ib)
Measured over From baseline, up to 21 days after last dose of investigational product
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Rosa Nadal Rios, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must be at least 18 years of age on the day of signing informed consent. Participant (or legally authorized representative if applicable) provides written informed consent for trial
Participants must have previously untreated locally advanced or metastatic bladder cancer including bladder cancer \[stage IIIB: T1-T4N2-3M0, stage IVa: T4bAnyNM0 or AnyTAnyNM1a, and stage IVB: AnyTAnyNM1b clinical stage per American Joint Commission on Cancer (AJCC)\] or renal pelvis or ureter cancer \[stage IV: T4Nx-0M0, AnyTN1-2M0, AnyTAnyNM1 clinical stage per AJCC\]. Lymph node with ≥ 15 mm short axis or biopsy-positive for carcinoma will be considered pathologically enlarged and measurable
Participants must have either conventional urothelial carcinoma or urothelial carcinoma variants. A review of pathology by a local expert genitourinary (GU) pathologist is required to confirm the diagnosis. Any component (%) of non-conventional urothelial noted on tumor specimen is allowed for only histologic subtypes listed below in up to 20% of participants enrolled in this study.
Urothelial carcinoma with squamous differentiation
Urothelial carcinoma with glandular differentiation
Urothelial carcinoma with trophoblastic differentiation
Nested urothelial carcinoma
Tubular and microcystic urothelial carcinoma
Micropapillary urothelial carcinoma
Lymphoepithelioma-like urothelial carcinoma
Plasmacytoid urothelial carcinoma
Sarcomatoid urothelial carcinoma
Giant cell urothelial carcinoma
Lipid-rich urothelial carcinoma
Clear cell (glycogen rich) urothelial carcinoma
Poorly differentiated urothelial carcinoma
Squamous cell neoplasms including pure squamous cell carcinomas, verrucous carcinomas and squamous cell papilloma
Measurable disease by RECIST v 1.1
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
Available baseline fresh biopsy tissue sample obtained in the protocol RG1712006 though clinically indicated procedures or participants must be willing to undergo a baseline research biopsy when safe and feasible
Participant must have an estimated life expectancy of at least 3 months
Hemoglobin ≥ 9 gr/dl
Absolute neutrophil count: ≥ 1500/ µL
White blood cell count: ≥ 3000/µL
Absolute lymphocyte count: ≥ 1000/µL
Platelet count: ≥ 100.000/µL (without transfusion support)
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤ 2.5 x upper limit of normal (ULN)
Total bilirubin: ≤ 1.5 mg/dl except for patients with Gilbert's syndrome who must have a total bilirubin ≤ 3 mg/dl
Creatinine clearance: ≥ 30 ml/min/1.73m\^2 by the method of Chronic Kidney Disease Epidemiology Collaboration (CKI-EPI) or ≥ 30 ml/min by the method of 24 hour (h) clearance of creatinine calculation
International Normalized Ratio (INR): \< 1.5
Exclusion
Participants who are receiving any other investigational agents or concurrent anticancer treatment. Participants must have adequate treatment washout period before treatment, defined as: Major surgery (≥ 4 weeks), palliative radiation therapy (≥ 1 weeks from completion of treatment if they have recovered from the acute toxic effect of radiotherapy), prior adjuvant immunotherapy (≥ 4 weeks)
Participants whose tumors have any % neuroendocrine or small cell histology, glandular neoplasms, urachal carcinomas, tumor of mullerian type, mesenchymal tumors or urothelial tract hematopoietic and lymphoid tumors
Participants considered to be medically unfit for EV-P regimen as per Investigator discretion
Participants with concurrent use of systemic steroids (within 10 days of enrollment), except for physiologic doses of systemic steroid replacement or local (topical, nasal, intraarticular or inhaled) steroid use
Participants who have experienced disease progression following neoadjuvant or adjuvant systemic therapy within 12 months prior to enrollment will not be eligible
Patients with Fridericia's corrected QT interval (QTcF) interval at screening of \> 480 milliseconds.
Note: For any QTcF \> 480 milliseconds on initial electrocardiogram (ECG), a follow-up ECG will be performed to confirm QTcF interval prolongation and exclude the patient from this study
Participants with active systemic autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, inflammatory bowel disease). Participants with autoimmune endocrine disorders controlled by medical management (e.g. thyroid disorders, type 1 diabetes, or adrenal insufficiency) will not be excluded
Participants who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count \< 350 cells/microliter
Participants with known active hepatitis (i.e. Hepatitis B or C). Prior hepatitis (Hep) C infection is allowed as long as polymerase chain reaction (PCR) test is negative
Participants with clinically inactive brain metastases may be included. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole-brain radiation therapy and study treatment
Participants with new or progressive brain metastases (less or equal of 1 cm of larger diameter) are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the participant and the investigator favors participation in the clinical trial. Patients with leptomeningeal disease will be excluded
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy of assessment of the investigational regimen are eligible for this trial
Woman of childbearing potential with positive serum pregnancy test within 72 hours prior to enrollment. Active lactation is an exclusion criterion
What this trial measures
- Incidence of treatment related adverse events (Phase Ib)From baseline, up to 21 days after last dose of investigational product
As measured by Common Terminology Criteria for Adverse Events version (v) 6.
- Overall response rate (ORR) (Phase II)From baseline, up to disease progression or unacceptable side effects, up to 3 years after completion of study treatment
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Will calculate the count and percentage with a 95% confidence interval (CI).