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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
29.09.2021

Trial locations

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.

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 ID:
2024-516077-72-02
Protocol code:
CIVI/2018/NH-01
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Study of Zanidatamab for Patients with Previously Treated HER2-Expressing Solid Tumors

    Recruiting

    2 1 1
    Investigated drugs:
    Spain
  • A study of SKB410, enfortumab vedotin, and pembrolizumab combination for patients with locally advanced or metastatic urothelial cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France The Netherlands Spain