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Study on Nivolumab and Ipilimumab for Patients with Advanced Urothelial Cancer After Initial Chemotherapy

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 clinical trial is focused on studying a type of cancer called urothelial cancer, which affects the urinary system, including the bladder. The trial is specifically for cases where the cancer is advanced and cannot be removed by surgery. The study is investigating the effectiveness of two medications, Nivolumab and Ipilimumab, used together as a maintenance therapy. These medications are given after patients have completed their initial chemotherapy treatment. Nivolumab and Ipilimumab are types of immunotherapy, which means they help the body's immune system fight cancer.

The purpose of the study is to see if this combination of medications can help delay the progression of the cancer. Patients who participate in the study will receive the medications through an infusion, which is a way of delivering the drugs directly into the bloodstream. The study will monitor patients over a period to see how the cancer responds to the treatment and to check for any side effects. Some patients in the study may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, researchers will collect information on how long patients live without the cancer getting worse, overall survival rates, and any changes in the size of the cancer. They will also look at the quality of life reported by patients using questionnaires. The study aims to provide valuable insights into whether this treatment approach can offer benefits to patients with advanced urothelial cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing 4-6 cycles of first-line chemotherapy for unresectable locally advanced or metastatic urothelial cancer.
Eligibility is confirmed through a baseline CT scan showing no disease progression and meeting specific health criteria.
Step 2
Initial assessment
A comprehensive health evaluation is conducted to ensure readiness for the trial.
This includes blood tests to check organ function and a pregnancy test for women of childbearing potential.
Step 3
Treatment administration
The treatment involves two medications: nivolumab and ipilimumab, both administered intravenously.
Nivolumab is given as a solution for infusion at a concentration of 10 mg/mL.
Ipilimumab is given as a solution for infusion at a concentration of 5 mg/mL.
Step 4
Regular monitoring
Scheduled visits are required to monitor health and response to treatment.
These visits include physical exams, blood tests, and imaging studies to track disease status.
Step 5
Follow-up assessments
Regular assessments continue to evaluate the effectiveness of the treatment in delaying disease progression.
Patient-reported outcomes are collected through questionnaires to assess quality of life.
Step 6
Completion of trial
The trial is expected to conclude by June 2025.
Final evaluations are conducted to determine overall survival and response to treatment.

Who can join the trial?

17 criteria

Participants must be male or female and at least 18 years old.
Participants should not have worsening disease after 4-6 cycles of chemotherapy, as confirmed by a CT scan. The scan should show that the disease is stable or improving.
Tumor tissue samples must be available at the start of the study.
Participants must be willing and able to follow the study protocol, including attending scheduled visits and examinations.
Participants must have normal organ and bone marrow function, which includes:
- Hemoglobin levels of at least 9.0 g/dL.
- Absolute neutrophil count (a type of white blood cell) greater than 1500 per mm³.
- Platelet count of at least 100,000 per mm³.
- Serum bilirubin levels within normal limits, unless liver metastases are present.
- Serum transaminases (liver enzymes) within normal limits, unless liver metastases are present.
- Creatinine clearance (a measure of kidney function) greater than 30 mL/min.
- Female participants who can have children must have a negative pregnancy test and agree to use effective birth control during the study and for 5 months after the last treatment.
- Participants must provide written informed consent approved by an ethics committee before any trial activities begin.
- Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
- Participants must have a confirmed diagnosis of advanced or metastatic urothelial cancer, which is a type of cancer affecting the urinary system.
- Participants must have stage IV disease at the start of their first chemotherapy treatment.
- Participants must have completed 4 to 6 cycles of specific chemotherapy drugs (gemcitabine with cisplatin or carboplatin) as their first treatment.
- Participants must join the trial within 3 to 12 weeks after their last chemotherapy dose.

Who cannot join the trial?

5 criteria

Patients who have had their cancer surgically removed cannot participate. This study is for those with cancer that cannot be removed by surgery.
Patients whose cancer has spread to other parts of the body, known as metastatic cancer, are included, but if the cancer has progressed during or after first-line chemotherapy, they cannot participate.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Both men and women can participate, but certain health conditions or treatments may exclude them.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Hospital Universitario De Salamanca
Verified
Salamanca, Spain

Trial locations

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Investigated drugs

Nivolumab
is a medication used in this trial as a maintenance therapy. It is designed to help the immune system recognize and attack cancer cells. In this study, it is being tested to see if it can delay the progression of urothelial cancer after initial chemotherapy.
Ipilimumab
is another medication used alongside Nivolumab in this trial. It works by stimulating the immune system to fight cancer cells. The combination of Ipilimumab with Nivolumab is being evaluated for its effectiveness in maintaining the condition of patients with advanced urothelial cancer who have already undergone chemotherapy.

What is already known about the treatment

Nivolumab
Nivolumab is administered intravenously, typically as an infusion. It is currently being studied in clinical trials for its effectiveness in treating unresectable locally advanced or metastatic urothelial cancer. The main therapeutic indication is to delay disease progression in patients who have not progressed during or after first-line chemotherapy. Nivolumab works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.
Ipilimumab
Ipilimumab is also administered intravenously, usually as an infusion. It is being evaluated in combination with Nivolumab in clinical trials for the treatment of unresectable locally advanced or metastatic urothelial cancer. The primary therapeutic indication is to maintain disease control in patients after initial chemotherapy. Ipilimumab functions by inhibiting CTLA-4, a protein on T-cells, thereby boosting the immune system's ability to fight cancer. It is categorized as an immune checkpoint inhibitor.

Investigated diseases

Unresectable Locally Advanced or Metastatic Urothelial Cancer – This is a type of cancer that originates in the urothelial cells lining the bladder and other parts of the urinary tract. When described as "unresectable," it means the cancer cannot be removed completely through surgery. "Locally advanced" indicates that the cancer has spread beyond the original site but is still within the nearby region, while "metastatic" means it has spread to distant parts of the body. The disease progresses as cancer cells grow and invade surrounding tissues, potentially spreading to other organs. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the disease advances, it can lead to more severe symptoms and complications.