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Study of Sasanlimab with BCG or Alone for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Not Responding to BCG

Fast replyInvestigationalNo 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 Non-Muscle Invasive Bladder Cancer, a type of bladder cancer that has not spread into the muscle layer of the bladder. The study is testing a treatment called Sasanlimab, also known by its code name PF-06801591. Sasanlimab is a type of medication known as a monoclonal antibody, which is a protein designed to help the immune system fight cancer. The trial will explore how effective Sasanlimab is when used alone or in combination with another treatment called Bacillus Calmette-Guerin (BCG), which is a common therapy for this type of cancer.

The purpose of the study is to see if Sasanlimab, either by itself or with BCG, can help improve the outcomes for patients with high-risk non-muscle invasive bladder cancer. The study will include participants who have not previously received BCG treatment, as well as those whose cancer did not respond to BCG. Participants will be randomly assigned to receive either Sasanlimab with BCG, Sasanlimab alone, or BCG alone. The study will monitor participants over a period to assess how well the treatments work in preventing the cancer from returning or progressing.

Throughout the study, participants will receive regular injections of the treatment and will be closely monitored by healthcare professionals. The study aims to provide valuable information on the effectiveness of Sasanlimab in treating non-muscle invasive bladder cancer, potentially offering new options for patients with this condition. The trial is expected to continue until 2026, with ongoing assessments to determine the best treatment approach for this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is assigned to one of the cohorts based on their medical condition and previous treatment history.

    The participant must be at least 18 years old and have a confirmed diagnosis of high-risk, non-muscle invasive bladder cancer.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either sasanlimab in combination with Bacillus Calmette-Guerin (BCG) or sasanlimab as a single agent.

    The treatment involves subcutaneous injections, which means the medication is administered under the skin.

  3. Step 3

    Treatment administration

    For those receiving the combination treatment, BCG is administered as an induction course followed by maintenance doses.

    Participants receiving sasanlimab as a single agent will have regular injections according to the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored regularly to assess the effectiveness of the treatment and any side effects.

    Regular visits are scheduled for laboratory tests and other necessary procedures to ensure the participant's health and safety.

  5. Step 5

    Completion of the study

    The study is expected to conclude by November 2026.

    Participants will have a final evaluation to determine the overall outcomes of the treatment.

Who can join the trial?

14 criteria

  • Participants must be at least 18 years old at the time of signing the informed consent. In Japan, participants must be at least 20 years old.
  • Participants can be male or female. They must use birth control methods that follow local rules for clinical studies.
  • Participants must be able to give signed informed consent, which means they agree to follow the study's rules and requirements.
  • For Cohorts B1 and B2 only: Participants must have a confirmed diagnosis of **BCG-unresponsive high-risk, non-muscle invasive bladder cancer**. This means the cancer did not respond to a treatment called BCG. The diagnosis must be confirmed by a special review before joining the study.
  • For Cohorts B1 and B2 only: Participants must have received enough BCG therapy, which includes specific doses and courses of treatment within a certain time frame.
  • For Cohorts B1 and B2 only: Participants must have refused or are not eligible for a surgery called **radical cystectomy**, which involves removing the bladder.
  • Participants must have a confirmed diagnosis of high-risk, non-muscle invasive bladder cancer, which is a type of cancer in the bladder lining. This includes certain types of tumors as defined by medical guidelines.
  • Participants must have had all visible tumors removed through a procedure called **TURBT** (Transurethral Resection of Bladder Tumor) within 12 weeks before starting the study treatment.
  • Tumor tissue from the most recent TURBT must be available for testing a specific protein called **PD-L1**.
  • Participants must have an **ECOG Performance Status** of 2 or less, which is a measure of their ability to perform daily activities.
  • Participants must have adequate bone marrow function, which means their blood cell levels are within a certain range without recent medical support.
  • Participants must have adequate kidney function, measured by a test called **creatinine clearance**, which checks how well the kidneys are working.
  • Participants must have adequate liver function, which includes certain levels of liver enzymes and bilirubin, a substance made by the liver.
  • Participants must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.

Who cannot join the trial?

16 criteria

  • Patients who have had a different type of cancer in the past, unless it was treated and has not come back for a long time.
  • Patients who have a serious infection that is not being treated.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to the study drug or any of its ingredients.
  • Patients who have a condition that affects their immune system, which is the body's defense against illness.
  • Patients who are taking certain medications that might interfere with the study treatment.
  • Patients who have had another experimental treatment within a certain time before joining this study.
  • Patients who have a history of certain heart problems.
  • Patients who have a history of certain lung problems.
  • Patients who have a history of certain liver problems.
  • Patients who have a history of certain kidney problems.
  • Patients who have a history of certain blood disorders.
  • Patients who have a history of certain neurological disorders, which affect the brain and nerves.
  • Patients who have a history of certain psychiatric disorders, which affect mental health.
  • Patients who have a history of substance abuse, which means using drugs or alcohol in a harmful way.
  • Patients who are unable to follow the study procedures or instructions.
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Investigated drugs

  • PF-06801591

    is an experimental medication being studied for its potential to help the immune system fight cancer. It is an anti-PD-1 antibody, which means it works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this trial, it is being tested both on its own and in combination with another treatment to see if it can improve outcomes for patients with certain types of bladder cancer.

  • Bacillus Calmette-Guerin (BCG)

    is a type of immunotherapy used to treat bladder cancer. It involves introducing a weakened form of bacteria into the bladder, which helps stimulate the body's immune response to attack cancer cells. In this trial, BCG is used both as an initial treatment (induction) and as ongoing treatment (maintenance) to see if it can help prevent the cancer from returning or spreading.

What is already known about the treatment

PF-06801591 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating non-muscle invasive bladder cancer. It is an anti-PD-1 antibody, which means it works by blocking the PD-1 protein on immune cells, helping the immune system to better detect and attack cancer cells. The main therapeutic indication for PF-06801591 is high-risk, BCG-naïve, and BCG-unresponsive non-muscle invasive bladder cancer. It is classified pharmacologically as an immune checkpoint inhibitor.

Investigated diseases

Non-Muscle Invasive Bladder Cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the lining of the bladder that have not yet invaded the muscle layer. It often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. The disease is typically detected at an early stage, which allows for a range of treatment options aimed at preventing progression. Over time, if not managed, it may recur or progress to a more invasive form. The progression of the disease is monitored through regular check-ups and imaging tests. The focus is on managing the condition to maintain bladder function and prevent further spread.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509089-39-00Protocol codeB8011006Estimated enrolment1 070 patientsSponsorPfizer Inc.

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