All studies
RecruitingTherapeutic exploratory (Phase II)Interventional

Phase 2 study of neoadjuvant immune checkpoint inhibitors in urothelial cancer (ABACUS-2)

The ABACUS-2 trial is looking at a treatment for adults with specific types of urinary tract cancer who are due to have surgery. This includes people with rarer types of bladder cancer or high-risk cancers in the upper urinary tract (the tubes connecting the kidneys to the bladder). Participants receive an immunotherapy drug called atezolizumab (Tecentriq) through a vein before their operation. Immunotherapy works by helping your body’s own immune system recognise and attack cancer cells. The main aim of this study is to see if giving atezolizumab before surgery can clear away the cancer completely by the time the operation takes place. Doctors will also check how safe the medicine is, track any side effects, and monitor how well patients recover and stay free of cancer in the years after their operation.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Queen Mary University Of London
Enrolment target
30
Start
20 Sep 2024

What is this study about?

Urothelial cancer is a type of cancer that begins in the lining of the urinary system. While it most commonly affects the bladder, it can also appear in the upper urinary tract, which includes the kidneys and the tubes that carry urine to the bladder. The standard treatment often involves surgery to remove the affected tissue. However, doctors are always looking for ways to improve surgery results and stop cancer from coming back.

This study, called ABACUS-2, tests a medicine called atezolizumab (brand name Tecentriq). Atezolizumab is an immunotherapy. Instead of attacking cancer cells directly like chemotherapy does, it works by 'taking the brakes off' your body's immune system, allowing your white blood cells to hunt down and destroy cancer cells.

In this trial, patients receive atezolizumab before their planned operation. Giving treatment before surgery is known as 'neoadjuvant' therapy. The hope is that the medicine will shrink the tumour or clear it completely before the surgeon operates. When tissue is removed during surgery, doctors will examine it under a microscope to see if any active cancer cells remain.

This research is particularly important because it includes patients with rare forms of bladder cancer and high-risk upper urinary tract cancers, who often have fewer treatment options. If successful, the results could help shape future NHS treatments and improve survival for people with these conditions.

Key takeaways

  • ABACUS-2 is testing the immunotherapy drug atezolizumab before surgery for urinary tract cancers.
  • The study focuses on rare bladder cancer types and high-risk upper urinary tract cancers.
  • The main goal is to find out if the drug can clear cancer cells before the tumour is surgically removed.
  • The trial will also monitor drug safety, side effects, and long-term health.
  • Taking part is voluntary, and you can withdraw at any time without losing standard NHS care.

Who may be eligible?

You may be able to join this study if you are 18 or older and have been diagnosed with cancer in your bladder or upper urinary tract that requires surgery. The trial focuses particularly on people who have certain rare subtypes of bladder cancer or high-risk tumours in the upper urinary tract.

To take part, your planned treatment must include an operation to remove the tumour, and you must be well enough to safely receive immunotherapy and undergo surgery.

You might not be able to take part if you have certain other serious medical conditions, such as severe autoimmune diseases, or if you have already had specific treatments that could interfere with how the study drug works. Your hospital specialist can check your full medical history to see if this trial is suitable for you.

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.

  1. I am aged 18 or older.
  2. I have been diagnosed with cancer of the bladder or upper urinary tract.
  3. My cancer is considered high-risk or has a rare cell pattern.
  4. My doctors have recommended surgery to remove the cancer.
  5. I am well enough to attend hospital visits for drip treatments and checks before surgery.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive atezolizumab as an intravenous infusion (a slow drip into a vein in your arm). This is given at the hospital before your scheduled surgery. Before each treatment, you will have routine checks such as blood tests, physical exams, and scans to monitor your health and see how the tumour is responding. After your surgery, the tissue that was removed will be sent to a laboratory to check if any living cancer cells are left. You will then have regular follow-up appointments over several months or years so the care team can check your recovery and make sure the cancer has not returned.

Potential risks and benefits

Taking part may help shrink your tumour before surgery, and the information gathered could help future cancer patients. However, there is no guarantee that the treatment will work for everyone. Atezolizumab can cause side effects because it activates the immune system; common ones include fatigue, loss of appetite, nausea, skin rashes, and joint aches. Less commonly, it can cause inflammation in organs like the lungs, bowel, or liver. Your medical team will monitor you very closely and can treat side effects promptly. Taking part is entirely voluntary, and you are free to leave the trial at any time without it affecting your standard NHS care.

Locations (2)

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

Common questions

What is an immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's natural immune system recognise and fight cancer cells, rather than attacking the cells directly like chemotherapy.

Will joining the study delay my planned surgery?

The trial is carefully planned so that your drug treatment happens within a set window before your operation, aiming to avoid any unnecessary delays to your surgical care.

How is the medicine given?

Atezolizumab is given through a drip directly into a vein, usually during a day visit to the hospital clinic.

What happens if I experience side effects?

You will have regular check-ups with the research team. If you have side effects, doctors can give medicines to ease them or pause the treatment if needed to keep you safe.

Can I leave the trial if I change my mind?

Yes, you can leave the study at any time without giving a reason. Your doctors will continue to give you the standard treatment and care you need.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Phase 2 study of neoadjuvant immune checkpoint inhibitors in…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.