Clinical trial for Locally Advanced Bladder Urothelial Carcinoma
Official title Enfortumab Vedotin, Pembrolizumab and Quemliclustat for the Treatment of Unresectable Locally Advanced and Metastatic Urothelial Cancer
ClinicalTrials.gov ID: NCT07667335
What this study is testing
What is Quemliclustat?
This is an investigational medicine being studied as a potential treatment for locally advanced or metastatic bladder cancer. It is designed to stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Also referred to as AB 680.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the safest dose of a new drug called quemliclustat when used with two other cancer treatments. It also checks if this combination helps control the cancer.
- Who it's for
- People with advanced bladder, kidney, or ureter cancer that has spread or cannot be removed by surgery.
- What's involved
- Participants will receive three drugs: enfortumab vedotin, pembrolizumab, and quemliclustat. They will have regular checkups and tests to monitor their health and how the cancer is responding.
- Time commitment
- The study involves ongoing visits for treatment and monitoring until the cancer grows or the treatment is stopped.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must be at least 18 years of age on the day of signing informed consent. Participant 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...
- Participants must have either conventional urothelial carcinoma or urothelial carcinoma variants.
- Urothelial carcinoma with squamous differentiation
- Urothelial carcinoma with glandular differentiation
You likely can't join if
- Participants who are receiving any other investigational agents or concurrent anticancer treatment.
- Participants whose tumors have any % neuroendocrine or small cell histology, glandular neoplasms, urachal carcinomas, tumor of mullerian type...
- 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...
- Participants who have experienced disease progression following neoadjuvant or adjuvant systemic therapy within 12 months prior to enrollment will...
- Patients with Fridericia's corrected QT interval (QTcF) interval at screening of \> 480 milliseconds.
See the full eligibility criteria
Who can join
- Participants must be at least 18 years of age on the day of signing informed consent. Participant 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...
- 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.
- 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 or RG1125031 though clinically indicated procedures or participants must be willing to undergo a baseline research biopsy when safe and...
- Participant must have an estimated life expectancy of at least 3 months
- Hemoglobin ≥ 9 g/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
What rules you out
- Participants who are receiving any other investigational agents or concurrent anticancer treatment.
- 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 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...
- 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...
- 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...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works of assessment of the investigational regimen are...
- Woman of childbearing potential with positive serum pregnancy test within 72 hours prior to enrollment. Active lactation is an exclusion criterion
The study team makes the final eligibility decision.
Where it is enrolling
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.