Not yet recruiting

Study of Disitamab Vedotin and Pembrolizumab for Patients with Advanced or Metastatic Urothelial Cancer Expressing HER2

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 carcinoma, which affects the bladder and other parts of the urinary system. The study is investigating the effects of two treatments: Disitamab Vedotin and Pembrolizumab. Disitamab Vedotin, also known by its code name SGN-DV, is a medication given through an intravenous infusion, which means it is delivered directly into the bloodstream. Pembrolizumab, another medication used in this study, is also administered through an intravenous infusion.

The purpose of the study is to evaluate how effective and safe these treatments are when used alone or in combination for patients with urothelial carcinoma that shows a specific characteristic called HER2 expression. HER2 is a protein that can affect the growth of cancer cells. The study will involve participants who have either previously received treatment for their cancer or are receiving treatment for the first time. The study will monitor the participants over a period to observe the effects of the treatments on their cancer.

Participants in the study will receive either Disitamab Vedotin alone or in combination with Pembrolizumab. The study will track the progress of the cancer and any side effects experienced by the participants. The goal is to gather information on how well these treatments work and their safety for patients with HER2-expressing urothelial carcinoma. The study is designed to provide valuable insights into potential new treatment options for this type of cancer.

The research process

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

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, medical staff will review your medical history and perform necessary tests to confirm your eligibility for the trial.
You will be required to provide a sample of your tumor tissue. If an archived sample is not available, a new biopsy will be conducted within 28 days before starting the treatment.
Step 2
Treatment cycle 1
The treatment involves receiving medications through an intravenous infusion. This means the medication is delivered directly into your bloodstream through a vein.
You will receive disitamab vedotin as a powder mixed into a solution for infusion. If you are in the combination group, you will also receive pembrolizumab, which is a solution for infusion.
Step 3
Ongoing treatment
The treatment will continue in cycles. Each cycle lasts for a specific period, during which you will receive the medications at regular intervals as determined by the study protocol.
Your health and response to the treatment will be closely monitored through regular check-ups and tests.
Step 4
Follow-up visits
After completing the treatment cycles, you will have follow-up visits. These visits are important to monitor your health and any long-term effects of the treatment.
The frequency and duration of these follow-up visits will be explained to you by the medical staff.

Who can join the trial?

11 criteria

Expected to live for at least 12 weeks.
Have an ECOG performance status score of 0, 1, or 2. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while a score of 2 means unable to work but able to take care of oneself.
Have locally-advanced, unresectable, or metastatic urothelial cancer. This means the cancer has spread and cannot be removed by surgery.
For certain groups (Cohorts A and B), must have received 1 or 2 previous treatments for this type of cancer, including one with platinum-based chemotherapy.
For another group (Cohort C), must not have had any previous treatments for this type of cancer, except if the cancer returned more than 12 months after the last treatment.
For Cohorts A and B, there must be proof of cancer progression during or after the last treatment.
Have at least one measurable tumor, as determined by the doctor using specific guidelines (RECIST version 1.1).
For Cohort C, must be eligible to receive chemotherapy containing cisplatin or carboplatin, as evaluated by the doctor.
Must be able to provide a sample of the tumor tissue before starting treatment. If a previous sample is not available, a new biopsy is required within 28 days before starting the treatment.
The tumor must show HER2 expression, which is a protein that can affect the growth of cancer cells. This will be determined by a central laboratory.
Both men and women can participate.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than urothelial carcinoma cannot participate.
Patients who have not been previously treated for their cancer are not eligible.
Patients whose cancer does not express HER2 (a protein that can affect the growth of cancer cells) are excluded.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population are not eligible.

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Verified sites

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

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta
Verified
Milan, Italy
Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

Disitamab Vedotin
is a type of targeted cancer treatment known as an antibody-drug conjugate. It is designed to find and attach to a specific protein called HER2, which is found on the surface of some cancer cells. Once attached, it delivers a powerful drug directly into the cancer cell to help kill it. This medication is being tested to see how well it works on its own in patients who have already received other treatments for their cancer.
Pembrolizumab
is a type of immunotherapy that helps your immune system fight cancer. It works by blocking a protein called PD-1, which can stop the immune system from attacking cancer cells. By blocking this protein, pembrolizumab helps the immune system recognize and destroy cancer cells more effectively. In this trial, it is being tested in combination with disitamab vedotin to see if the two medications together can improve treatment outcomes for patients who have not yet received treatment for their cancer.

What is already known about the treatment

Disitamab Vedotin – Disitamab Vedotin is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating urothelial carcinoma, a type of bladder cancer. The medication works by targeting and binding to a protein called HER2 on cancer cells, delivering a toxic substance directly to these cells to kill them. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

Urothelial carcinoma – Urothelial carcinoma is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It typically starts in the bladder but can also occur in the ureters and renal pelvis. The disease progresses as the cancer cells grow and invade deeper layers of the bladder wall and potentially spread to nearby tissues and organs. Over time, it may metastasize to distant parts of the body, such as the lymph nodes, liver, lungs, and bones. The progression of the disease can vary, with some cases remaining superficial and others becoming more invasive. The growth and spread of the cancer cells can lead to various symptoms, including blood in the urine, frequent urination, and pain during urination.