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Study of Enfortumab Vedotin and Pembrolizumab for Bladder Preservation in Patients with Muscle‑Invasive Bladder Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Muscle-invasive Bladder Cancer is a form of bladder cancer that has grown into the muscle layer of the bladder wall. The study looks at whether a combination of two medicines, enfortumab vedotin given as a solution for infusion and pembrolizumab given as an injection, can treat this condition while allowing the bladder to be kept intact.

The purpose of the study is to find out if the drug combination can lead to a clinical complete response, meaning no detectable cancer after treatment, and to see how many participants remain free of disease for two years. Researchers will also record any side effects and overall safety.

Participants will receive the two medicines together in a series of treatment cycles over several months, with regular doctor visits, scans, and lab tests to check how the cancer is responding and to monitor health. After the treatment period, follow‑up visits will continue for up to two years to observe long‑term outcomes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment visit

    On the first day after joining the study you receive two medicines. enfortumab vedotin is given as a 125 mg infusion (a liquid that is delivered into a vein). pembrolizumab is given as a 400 mg injection (a liquid that is delivered under the skin or into a vein). the exact schedule for repeating these medicines is defined by the study protocol.

    The medical team monitors you for any immediate reactions during and after the administration of the medicines.

  2. Step 2

    Subsequent treatment cycles

    You return for additional treatment cycles as instructed by the study schedule. each cycle includes the same doses of enfortumab vedotin (125 mg) and pembrolizumab (400 mg). the interval between cycles is determined by the protocol, but the same medicines and doses are used each time.

  3. Step 3

    Assessment after four cycles

    After completing four cycles of treatment, the investigators evaluate whether a complete clinical response has been achieved. a complete clinical response means that no signs of cancer are found with the tests used in the study.

  4. Step 4

    Ongoing follow‑up

    Following the treatment period, you are followed for up to two years. during this time the investigators assess bladder‑preservation event‑free survival, which measures how long the bladder remains cancer‑free without any events related to the disease.

Who can join the trial?

7 criteria

  • You must be 18 years old or older when you sign the informed consent form.
  • You need to have bladder cancer that has grown into the muscle layer, confirmed by looking at tissue under a microscope, and it must be in one of the specific early‑stage categories (stage cT2‑cT4a, with or without limited spread to nearby lymph nodes).
  • At least half of the tumor must be made up of urothelial carcinoma, which is the most common type of bladder cancer.
  • A urologist or cancer doctor must determine that you are a candidate for surgery to remove the bladder (radical cystectomy) and to remove nearby lymph nodes (pelvic lymph node dissection).
  • You must have a stored sample of your tumor tissue that can be accessed, or you will need a small tissue sample taken (a biopsy) before the study starts.
  • Your overall health and ability to carry out daily activities must be rated between 0 and 2 on the ECOG performance status scale (0 = fully active, 2 = able to care for yourself but not able to work).
  • You must have had a tumor removal procedure called transurethral resection of bladder tumor (TURBT) within about two months (60 days, plus up to 14 days) before the screening visit.

Who cannot join the trial?

13 criteria

  • Having existing nerve problems that cause numbness or weakness (known as sensory or motor neuropathy) at a moderate level or worse (Grade ≥ 2) excludes you.
  • Having cancer that has spread to many lymph nodes (N2 disease) or to other parts of the body (metastatic disease, M1) as seen on imaging excludes you.
  • Having uncontrolled diabetes within the last three months excludes you. This is defined as a blood sugar control test called HbA1c of 8 % or higher, or an HbA1c between 7 % and < 8 % with symptoms like frequent urination or extreme thirst.
  • Having a second cancer diagnosed within three years before the study, or still having any leftover disease from a previous cancer, excludes you. (Exceptions are low‑risk non‑melanoma skin cancers, localized prostate cancers treated with cure intent, very low‑risk prostate cancers under watchful waiting, or carcinoma in situ that has been completely removed.)
  • Having received any previous treatment with drugs that block the immune checkpoints PD‑1, PD‑L1, PD‑L2 or other similar agents that affect T‑cell activity (such as CTLA‑4, OX‑40, CD137) excludes you.
  • Having received any prior systemic (whole‑body) anti‑cancer therapy for bladder cancer, or any investigational drugs (including enfortumab vedotin or other drugs that use the toxin MMAE attached to an antibody, called ADC) within three years before screening excludes you.
  • Having had a partial removal of the bladder (partial cystectomy) for bladder cancer excludes you.
  • Having received any radiation treatment to the bladder (radiotherapy) before the study excludes you.
  • Having an active eye surface infection or inflammation such as keratitis or an open sore on the eye (corneal ulceration) excludes you, unless it is a mild form called superficial punctate keratitis that is being treated.
  • Having a past history of non‑infectious lung inflammation (pneumonitis) or interstitial lung disease (ILD) that needed steroid treatment, or currently having pneumonitis/ILD, excludes you.
  • Having a history of specific lung diseases such as idiopathic pulmonary fibrosis, organizing pneumonia, drug‑induced pneumonitis, idiopathic pneumonitis, or showing active lung inflammation on a screening chest CT scan excludes you.
  • Having an immune system deficiency (immunodeficiency) or taking strong systemic steroids (more than 10 mg of prednisone or equivalent each day) or other immune‑suppressing medicines within seven days before the first dose excludes you. Inhaled or skin‑applied steroids are allowed if there is no active autoimmune disease, and low‑dose replacement steroids are allowed for adrenal insufficiency.
  • Having an active autoimmune disease (where the body attacks itself) that required systemic treatment (such as disease‑modifying drugs, steroids, or other immune‑suppressing medicines) in the past two years excludes you.
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Investigated drugs

  • Enfortumab vedotin

    (brand name Padcev) is a medicine that attaches to a protein found on bladder cancer cells. It carries a chemotherapy drug straight to those cells, helping to kill the cancer while causing less damage to normal cells. In this study the drug is given through an IV infusion and is combined with pembrolizumab to try to shrink or remove the tumor so the bladder can be saved.

  • Pembrolizumab

    (brand name Keytruda) is an immunotherapy that helps the body’s immune system see and attack cancer cells. It is given as an injection and works together with enfortumab vedotin to increase the chance that the cancer disappears completely and stays gone.

What is already known about the treatment

  • Enfortumab vedotin

    This medication is supplied as a powder that is mixed with a liquid and given by intravenous infusion. It is an approved cancer drug that is widely described in medical literature and is used mainly for bladder cancer and other urothelial cancers. It works by linking an antibody that finds a protein on cancer cells to a cell‑killing drug, delivering the toxin directly to the tumor. It belongs to the class of antibody‑drug conjugates.

  • Pembrolizumab

    This medication comes as a ready‑to‑use liquid that is injected into a vein (intravenous injection). It is an approved immunotherapy found in many clinical studies and is used for several cancers, including bladder cancer. It helps the immune system attack cancer by blocking the PD‑1 checkpoint, which lets immune cells see and kill tumor cells. It is classified as a monoclonal antibody checkpoint inhibitor.

Investigated diseases

Muscle-invasive bladder cancer - It is a type of bladder cancer that has grown from the inner lining into the muscle layer of the bladder wall. The disease begins as abnormal cells in the bladder lining and then spreads deeper into the muscle. As it progresses, it can extend to nearby tissues and regional lymph nodes. This growth may cause changes in urinary habits, such as blood in the urine or difficulty urinating. The cancer continues to expand outward if not controlled.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524488-18-00Protocol code7465-CL-0209Estimated enrolment240 patientsSponsorAstellas Pharma Global Development Inc.

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