Muscle Invasive Bladder Urothelial Carcinoma study: Enfortumab vedotin vs Pembrolizumab
Official title Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06809140
What this study is testing
What is Enfortumab vedotin?
An investigational once‑weekly injectable medicine being studied for muscle invasive bladder urothelial carcinoma. It is designed to target and kill cancer cells that express the Nectin‑4 protein.
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
- The study wants to see if this drug combo can shrink the cancer enough to avoid surgery and keep the bladder working.
- Who it's for
- Adults with muscle‑invasive bladder cancer that has not spread to other parts of the body.
- What's involved
- You will get 3 rounds of the two drugs, then a scan and cystoscopy to check the bladder. If the cancer looks gone, you will get 14 more rounds of the drugs, with the first 6 rounds including enfortumab vedotin. If any cancer remains, you may need surgery.
- Time commitment
- The treatment lasts about 17 months, with visits for drug infusions, scans, and cystoscopy every few weeks during the first 3 months and then monthly for the rest of the study.
- 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
- Written informed consent and HIPAA authorization for release of personal health information prior to registration.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder clinical stage T2-3N0M0.
- Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 90 days prior C1D1.
You likely can't join if
- Pre-existing sensory or motor neuropathy Grade ≥ 2
- Ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic...
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured.
- Prior radiation therapy for bladder cancer.
- Hemoglobin A1c ≥ 8% or hemoglobin A1c 7%-\<8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained
See the full eligibility criteria
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0-1 within 28 days prior to registration.
- Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder clinical stage T2-3N0M0.
- Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 90 days prior C1D1.
- All people must have adequate transurethral resection of bladder tumor tissue available for submission identified during screening.
- Be deemed eligible to undergo radical cystectomy and pelvic lymph node dissection
- Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
- Absolute neutrophil count (ANC): ≥ 1.5 x 10\^9/L
- Hemoglobin (Hgb): ≥ 9 g/dL
- Platelets: ≥ 100 x 10\^9/L
- Creatinine clearance: ≥ 30 mL/min
- Bilirubin: ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN
- Aspartate aminotransferase (AST): ≤ 2.5 × ULN
- Alanine aminotransferase (ALT): ≤ 2.5 × ULN
- International normalized ratio (INR) or Prothrombin time (PT) or Partial thromboplastin time (PTT): ≤ 1.5 ×ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range for...
- Pre-existing sensory or motor neuropathy Grade ≥ 2
- Ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured.
- Prior radiation therapy for bladder cancer.
- Hemoglobin A1c ≥ 8% or hemoglobin A1c 7%-\<8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained
- Active infection requiring systemic therapy.
- Known active Hepatitis B or C infection. NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load are eligible.
- Has a known history of active TB (Bacillus Tuberculosis).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab or enfortumab vedotin and/or any of their excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- Has had an allogenic tissue/solid organ transplant.
- Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Indianapolis, Indiana, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, 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 Duarte, California, United States; Indianapolis, Indiana, United States; New York, New York, United States; Philadelphia, Pennsylvania, 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.