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New treatment option for Adenocarcinoma of the Bladder
Official title Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)
ClinicalTrials.gov ID: NCT06041503
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for adenocarcinoma of the bladder.
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
- Background: Many cancers of the testicles and urinary tract are rare diseases; these are diseases that affect less than 200,000 people in the United States. It can be hard to study treatments for these diseases.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Participants must have histologically confirmed locally advanced or metastatic pure adenocarcinoma of the urinary tract, pure squamous cell carcinoma...
- Participants must have measurable disease, per RECIST 1.1.
- Participants must have locally advanced or metastatic disease defined as new or progressive lesions on cross sectional imaging.
- Participants in Cohorts A1, B1, and C1 must have received prior anti-PD-1/PD-L1 therapy in any setting.
- Participants in Cohorts A2, B2, and C2 must be immune checkpoint inhibitor naive.
You likely can't join if
- Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone directed therapy)...
- Participants with prior treatment with EV or other MMAE-based ADCs.
- Participants with preexisting sensory or motor neuropathy Grade \>= 2.
- History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to EV and/or pembrolizumab.
- Symptomatic or untreated central nervous system (CNS) metastases. Note: Participants with previously treated brain or CNS metastases are eligible if...
- Participants will be excluded if they have an active autoimmune disease that might deteriorate when receiving pembrolizumab except for:
See the full eligibility criteria
Who can join
- Participants must have histologically confirmed locally advanced or metastatic pure adenocarcinoma of the urinary tract, pure squamous cell carcinoma of the urinary tract, or treatment-refractory testicular germ cell...
- Participants must have measurable disease, per RECIST 1.1.
- Participants must have locally advanced or metastatic disease defined as new or progressive lesions on cross sectional imaging.
- Participants in Cohorts A1, B1, and C1 must have received prior anti-PD-1/PD-L1 therapy in any setting.
- Participants in Cohorts A2, B2, and C2 must be immune checkpoint inhibitor naive.
- Participants may be systemic treatment naive except for participants with testicular germ cell tumors, who must have received and be refractory to all standard options of curative-intent treatment.
- Age \>= 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \ = 70%)
- Participants must have adequate organ and marrow function as defined below:
- Hemoglobin (Hgb) \>= 9g/dL
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin \<= 1.5 x upper limit of normal (ULN) (\<= 3 x ULN in participants with known/suspected Gilbert's disease)
- Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \<= 2.5 x institutional ULN
- Creatinine clearance (CrCl) \>= 30 mL/min/1.73m\^2 as estimated per institution standards.
- Pre-study treatment tissue availability (sufficient tissue for 25 unstained slides) is mandatory for enrollment. If tissue is determined to be insufficient/unsuitable, a fresh biopsy prior to study therapy will be...
- Human immunodeficiency virus (HIV) positive participants are eligible if on stable dose of highly active antiretroviral therapy (HAART) for at least 3 months, CD4 counts are \> 200 cells/mm\^3 and viral load (VL) is...
- Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry and with planned monitoring and management according to appropriate...
- Hepatitis C virus (HCV) positive participants are eligible if participants are on active HCV therapy at study entry and on a stable dose of antivirals without documented clinically significant impaired liver function...
- Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence prior to study entry, for the duration of study participation, and for at...
- Men able to father children must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after the last dose of the...
- Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 4 months after the last dose of the pembrolizumab and 3 weeks after the last dose of EV.
- Participants must be able to understand and willing to sign a written informed consent document.
What rules you out
- Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone directed therapy) within the past 2 weeks prior to the first study drug administration...
- Participants with prior treatment with EV or other MMAE-based ADCs.
- Participants with preexisting sensory or motor neuropathy Grade \>= 2.
- History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to EV and/or pembrolizumab.
- Symptomatic or untreated central nervous system (CNS) metastases. Note: Participants with previously treated brain or CNS metastases are eligible if the participants have recovered from any acute effects of radiotherapy...
- Participants will be excluded if they have an active autoimmune disease that might deteriorate when receiving pembrolizumab except for:
- Diabetes type I, eczema, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment.
- Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses \<= 10 mg of prednisone or equivalent per day.
- Administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation).
- Participants on systemic intravenous or oral corticosteroid therapy with the exception of physiologic doses of corticosteroids (\ 14 days). In addition, the use of corticosteroids as premedication for contrast-enhanced...
- History of uncontrolled diabetes mellitus within 3 months before the first dose of EV. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) \>= 8% or HbA1c between 7 and \< 8% with associated diabetes symptoms...
- Active keratitis or corneal ulcerations.
- Participants who have received or will receive a live vaccine within 30 days prior to the first administration of study intervention. Seasonal flu vaccines that do not contain a live virus are permitted. Locally...
- Pregnant women as evaluated by a positive serum or urine beta-human chorionic gonadotropin (Beta-hCG) test at screening.
- Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel.
- Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel. Participants with a prior (within 2 years of...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.