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Study of Durvalumab Combined with Chemotherapy (Gemcitabine/Cisplatin or Gemcitabine/Carboplatin) for Patients with High-Risk Upper Urinary Tract Cancer Before Surgery

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

This study focuses on urothelial carcinoma of the upper urinary tract, which is a type of cancer affecting the lining of the kidney's collecting system and ureter (the tube connecting kidney to bladder). The treatment combines several medications: durvalumab, which helps the immune system fight cancer cells, along with chemotherapy drugs including gemcitabine paired with either cisplatin or carboplatin.

The purpose of this study is to determine how well the combination of these medications works in treating high-risk, localized upper urinary tract cancer before surgery. The treatment involves receiving the medications through an intravenous infusion, followed by an operation called nephroureterectomy, which removes the affected kidney and ureter.

During the study, patients will receive the combination treatment before undergoing surgery. After the surgery, doctors will examine the removed tissue to see if any cancer cells remain. The study will monitor patients for side effects of the treatment and track their recovery for two years after surgery. This includes checking if the cancer returns in the bladder or spreads to other parts of the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your diagnosis of urothelial carcinoma (cancer of the urinary tract) will be confirmed through previous biopsy results or urine tests

    A CT scan will be performed to assess your condition and confirm eligibility for surgery

    Your overall health status will be evaluated, including a performance status check

  2. Step 2

    Treatment preparation

    You will be assigned to receive one of two combination treatments:

    Option 1: Durvalumab with Gemcitabine and Cisplatin

    Option 2: Durvalumab with Gemcitabine and Carboplatin

    All medications will be administered through intravenous infusion

  3. Step 3

    Treatment phase

    You will receive the assigned combination of medications before surgery

    During treatment, your health status will be regularly monitored

    Side effects will be tracked using standardized criteria

  4. Step 4

    Surgery

    After completing the medication phase, you will undergo radical nephroureterectomy surgery

    Tissue samples will be collected during surgery for analysis

    A pathologist will examine the samples to assess how well the treatment worked

  5. Step 5

    Follow-up period

    Your recovery will be monitored after surgery

    Regular check-ups will continue for 2 years after surgery

    Doctors will track any signs of cancer recurrence in the bladder or elsewhere in the body

Who can join the trial?

10 criteria

  • Patient must have confirmed high-grade urothelial carcinoma (a type of cancer) in the kidney area or ureter (the tube connecting kidney to bladder), proven by tissue sample or urine test
  • The cancer must be primarily of the urothelial type (at least 90% of the tumor), though some other cancer cell types may be present
  • Patient must have either:
    • High-grade cancer confirmed by tissue sample, or
    • High-grade cancer found in urine test plus signs of cancer spread on CT scan, with normal bladder examination
    • Patient must be at least 18 years old. For those over 70, a special fitness test (G8 score) must be 14 or higher
    • Body weight must be more than 30 kilograms
    • Patient must not have had any previous cancer treatments
    • Patient must be able to undergo radical nephroureterectomy (surgical removal of kidney and ureter)
    • Patient must have good physical function (ECOG status of 0 or 1, meaning able to perform most daily activities)
    • Cancer must not have spread beyond nearby lymph nodes, as shown on CT scan

Who cannot join the trial?

13 criteria

  • Prior treatment with immunotherapy drugs or targeted therapy for upper tract urothelial cancer
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Presence of any other type of cancer within the last 5 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions including heart failure, uncontrolled high blood pressure, or recent heart attack
  • Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Current treatment with medications that suppress the immune system
  • Active infection requiring treatment, including hepatitis B, hepatitis C, or HIV
  • History of organ transplant
  • Pregnant or breastfeeding women
  • Known allergy or sensitivity to study medications
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Inability to follow study procedures or attend scheduled visits
  • Mental conditions that could interfere with study participation or informed consent
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Investigated drugs

  • Durvalumab

    (also known as MEDI 4736) is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from the immune system, allowing the body's natural defenses to better recognize and attack the tumor.

  • Gemcitabine

    is a chemotherapy medication that works by preventing cancer cells from making DNA, which they need to multiply and grow. It belongs to a group of drugs called antimetabolites.

  • Cisplatin

    is a chemotherapy medication that works by damaging the DNA of cancer cells, which prevents them from dividing and causes them to die. It belongs to a group of drugs called platinum-based drugs.

  • Carboplatin

    is another platinum-based chemotherapy medication that works similarly to cisplatin by damaging cancer cell DNA. It is sometimes used as an alternative to cisplatin, particularly when patients cannot tolerate cisplatin's side effects.

What is already known about the treatment

  • Durvalumab

    A monoclonal antibody medication administered via intravenous infusion that works by blocking PD-L1 proteins on cancer cells, helping the immune system to detect and fight cancer cells. It is currently approved for treating various types of cancers and is being studied in clinical trials for urothelial carcinoma of the upper urinary tract in combination with chemotherapy. This immunotherapy belongs to the class of immune checkpoint inhibitors and works by preventing cancer cells from evading the body's immune response.

  • Gemcitabine

    An antimetabolite chemotherapy drug given through intravenous infusion that works by interfering with cancer cell DNA synthesis and blocking cell division. It is commonly used in combination with other chemotherapy drugs for treating various types of cancer, including urothelial carcinoma, and belongs to the nucleoside analog class of medications. The drug prevents cancer cells from making and repairing DNA, ultimately leading to cancer cell death.

  • Cisplatin

    A platinum-based chemotherapy medication administered intravenously that works by binding to DNA in cancer cells, preventing them from dividing and growing. It is a well-established chemotherapy drug used in many cancer treatments, including urothelial carcinoma, and belongs to the platinum-containing compounds class. This medication has been a cornerstone of cancer treatment for decades and is often used in combination with other chemotherapy drugs.

  • Carboplatin

    A platinum-based chemotherapy drug given through intravenous infusion that functions similarly to cisplatin but often with fewer side effects. It works by damaging the DNA of cancer cells, preventing them from dividing and spreading, and is commonly used as an alternative to cisplatin in patients who cannot tolerate its side effects. This medication belongs to the platinum-containing compounds class and is frequently used in combination therapy for various types of cancer.

Investigated diseases

Upper Tract Urothelial Carcinoma – A type of cancer that begins in the cells that line the renal pelvis and ureter, which are parts of the urinary system connecting the kidney to the bladder. This cancer develops from the urothelial cells (transitional cells) that form the inner lining of these structures. The cancer typically starts as small growths on the inner lining of the urinary tract. As it progresses, it can grow deeper into the wall of the ureter or renal pelvis. The condition can occur in either the renal pelvis (part of the kidney) or in the ureter (the tube that carries urine from the kidney to the bladder). The cancer may be classified as high-grade, meaning the cancer cells look very different from normal cells and tend to grow more aggressively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516077-72-02Protocol codeCIVI/2018/NH-01Estimated enrolment50 patientsSponsorCentre Hospitalier Universitaire De Nimes

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