AuthorisedTherapeutic exploratory (Phase II)Interventional

Safety and Efficacy of Neoadjuvant immunotherapy with Durvalumab (MEDI 4736) in combination with neoadjuvant chemotherapy (Gemcitabin/Cisplatin or Gemcitabin/Carboplatin) in patients with operable, high-risk, localized urothelial carcinoma of the upper urinary tract. iNDUCT - GETUG V08

This study is for people with a specific type of cancer in the kidney or tubes leading to the bladder (urothelial carcinoma of the upper urinary tract) that has not yet spread but is considered high-risk. Doctors are testing a new approach that combines an immunotherapy drug called Durvalumab (also known as Imfinzi) with standard chemotherapy (Gemcitabine either with Cisplatin or Carboplatin). The main goal is to see if this combination treatment, given before surgery, can completely get rid of all cancer cells in the tissue removed during the operation. This is called a 'pathological complete response'. The study also looks at how safe the treatment is and whether it helps shrink the cancer, as well as tracking patients' health over time.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nimes

Enrolment target

Start

28 Nov 2024

The patient has a histologically-confirmed (ureteroscopic biopsy) or cytologically(urine cytology)-confirmed diagnosis of high-grade urothelial carcinoma of the renal pelvis or ureter.

What is this study about?

This clinical trial, called iNDUCT, is investigating a new way to treat certain bladder or kidney cancers that are considered 'high-risk' but haven't spread to other parts of the body. These cancers are called urothelial carcinoma of the upper urinary tract. The study combines a newer type of drug called immunotherapy (specifically, Durvalumab, also known as Imfinzi) with standard chemotherapy. Immunotherapy works by helping your body's own immune system fight cancer cells.

The main aim of this study is to see if giving this combination of treatments *before* surgery can lead to a 'pathological complete response'. This means that when the doctors surgically remove the affected tissue, a specialist (a pathologist) examines it very closely under a microscope and finds no living cancer cells left. Finding no cancer cells would be a very positive outcome because it suggests the treatment has been highly effective in clearing the disease from that area.

Researchers are also carefully watching for other things. They want to see if the treatment helps shrink the cancer significantly (a 'pathological partial response'), how safe the treatment is, and if there are any side effects. They will also follow up with patients for two years after surgery to learn more about their overall health and if the cancer comes back in the bladder or spreads elsewhere. This is an important step to find better treatments for this specific type of cancer.

Key takeaways

Tests a new combination of immunotherapy and chemotherapy.
Treatment is given *before* surgery for specific kidney/bladder cancer.
Main goal is to see if all cancer cells are removed after surgery.
Also checks safety and how well the treatment shrinks the cancer.
Long-term follow-up for two years to monitor health.

Who may be eligible?

To take part in this study, you would need to be an adult, at least 18 years old, with a confirmed diagnosis of a specific type of cancer. This cancer is called high-risk urothelial carcinoma and it affects the kidney or the tubes connecting the kidney to the bladder (the renal pelvis or ureter). Importantly, this cancer should not have spread to other parts of your body.

Your cancer diagnosis needs to be confirmed by examining a tissue sample, usually obtained during a procedure called a ureteroscopy, or from cells found in a urine sample. The study is open to both men and women.

There will be other detailed medical criteria that your doctor will check to make sure the study is right for you and safe for you to participate. These might include your general health, other medical conditions you have, and certain blood test results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a confirmed high-risk urothelial cancer in your kidney or ureter?
Has your cancer not spread to other parts of your body?
Is your diagnosis confirmed by a tissue or urine sample?
Are you generally healthy enough to receive chemotherapy and immunotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive a combination of treatments before your surgery. This will involve an immunotherapy drug called Durvalumab given as a drip into your vein, along with standard chemotherapy, which will also be given as a drip. The specific chemotherapy you receive would be a combination of Gemcitabine with either Cisplatin or Carboplatin.

Throughout the treatment period and after, you will have regular visits to the hospital. These visits will involve blood tests, physical examinations, and possibly imaging scans to monitor your health and how the treatment is working. After your surgery, the tissue removed will be carefully examined to see the effect of the treatment. You will then have follow-up appointments for two years to track your health, including looking for any signs of the cancer returning or spreading. The total duration of active treatment before surgery and the follow-up period will vary by individual, but the follow-up alone is planned for two years.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and helping others by contributing to medical knowledge. However, there are also potential risks, including side effects from the study drugs that might be different or more severe than standard treatments. Your medical team will carefully monitor you for any side effects and provide appropriate care. You have the right to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What kind of cancer is this study for?

It's for a high-risk type of cancer in the kidney or the tubes connecting the kidney to the bladder (urothelial carcinoma of the upper urinary tract) that hasn't spread.

What are the main treatments being tested?

It's a combination of an immunotherapy drug called Durvalumab (Imfinzi) and standard chemotherapy, given before surgery.

What does 'pathological complete response' mean?

It means that after treatment and surgery, a detailed look at the removed tissue under a microscope shows no living cancer cells left.

How long will I be followed up after treatment?

You will be followed up for two years after your surgery to monitor your health and the cancer.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without affecting your medical care.