Pembrolizumab Maintenance After Enfortumab Vedotin/Pembrolizumab Induction for Urothelial Carcinoma
This study is testing a treatment approach for people with advanced urothelial carcinoma (a type of bladder cancer) that has spread and hasn't been treated before. It involves two medicines: enfortumab vedotin and pembrolizumab. You would first receive both medicines for about 18 weeks. If your cancer responds well, you would then receive pembrolizumab alone for up to two years. The main goal is to see how many people are still alive and without their cancer getting worse after 18 months. About 97 people will join this study. To be eligible, you must have measurable cancer and not have received prior treatment for metastatic disease.
- Study design
- This is a single-arm, open-label (meaning everyone knows what treatment they are getting) Phase II study, enrolling about 97 participants.
- What's involved
- You would receive intravenous (IV) infusions of enfortumab vedotin and pembrolizumab every 21 days for 18 weeks, followed by pembrolizumab infusions every 3 or 6 weeks for up to 2 years if your cancer responds. Radiographic assessments will occur after 3 and 6 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures progression-free survival at 18 months, suggesting follow-up for at least this duration.
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NCT07221942
Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentFox Chase Cancer CenterInvestigator-initiated
~97 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Enfortumab vedotinPembrolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
18-month progression-free survival (PFS)
Measured over 18 months
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Pooja Ghatalia, MD · PRINCIPAL_INVESTIGATOR · Fox Chase Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patients must have histologically and radiographically confirmed locally advanced, unresectable urothelial carcinoma.
Patients should not have received prior systemic therapy for metastatic disease.
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1
Patients may have received prior neoadjuvant or adjuvant immune checkpoint inhibitor therapy for localized disease and are eligible if they completed the treatment ≥12 months prior to initiating treatment on this clinical trial.
ECOG performance status 0-2
Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Archival tumor biospecimen (when available) must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study. Formalin fixed, paraffin embedded (FFPE) tissue block(s) or at least 25 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.
Normal organ and marrow function as defined below.
Absolute neutrophil count \> 1,000/mm3 unless patient has constitutional neutropenia
Platelets \> 100,000/µl
Hemoglobin \> 8.0 g/dL
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 x upper limit of normal (ULN) or \<3.5 x ULN if liver metastases
Creatinine Clearance \>20 ml/min
Exclusion
Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) for urothelial cancer.
Grade 2 or higher baseline sensory or motor neuropathy.
Uncontrolled diabetes (HbA1c \>8%)
Patients with uncontrolled and untreated central nervous system (CNS) metastases.
Prior radiation to CNS metastases is permitted.
Prior history of CNS disease that has responded to previous systemic therapy is permitted only if no recurrence.
Patient should not have leptomeningeal disease
CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.
If requiring steroid treatment for CNS metastases, the patient is on stable dose \< 10 mg/day of prednisone or equivalent for at least 2 weeks prior to starting treatment
Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would substantially impair the patient's ability to comply with study requirements. Efforts should be made to provide reasonable accommodations before determining exclusion based on social limitations.
Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug that cannot be watched and requires treatment, or any evidence of residual disease from a previously diagnosed malignancy that cannot be watched and requires treatment. Adjuvant hormonal therapy for breast cancer is allowed.
Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with enfortumab vedotin.
History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Prior allogeneic stem cell or solid organ transplant.
Other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.
Patients with active tuberculosis.
Pregnant or breast feeding
History of autoimmune diseases. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
Patients with vitiligo or residual autoimmune hypothyroidism on stable doses of hormone replacement are permitted to enroll.
Patients with type 1 diabetes mellitus (T1DM) on a stable dose of insulin are permitted to enroll.
Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
On high dose steroids at the time of study enrollment, defined as \>10 mg prednisone (or bioequivalent), including steroids used for management of intracranial lesions. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Patients who received prior immunotherapy for mUC or for an alternative malignancy are eligible unless they developed an immune related adverse event while on therapy requiring cessation of therapy or use of disease modifying agents, corticosteroids, or immunosuppressive drugs.
What this trial measures
- 18-month progression-free survival (PFS)18 months
radiographic progression or death from any cause within 18 months of initiating treatment