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Understanding the IMvigor011 Study: How Signatera™ Helps Guide Bladder Cancer Treatment

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What is IMvigor011?

IMvigor011 is a large, global research study that looked at a new way to guide treatment for people with muscle-invasive bladder cancer (MIBC).

The study used a personalized blood test called Signatera™ to look for small traces of cancer that may still be in the body after surgery. These leftover traces are called Molecular Residual Disease (MRD).

Doctors wanted to learn if this test could help decide who really needs extra treatment (immunotherapy) after bladder removal surgery.

How the Study Worked

After surgery, patients had regular Signatera™ blood tests every 6 weeks up to 1 year.

  • If Signatera found cancer DNA (Signatera-positive): The patient was randomly given either the immunotherapy drug atezolizumab (Tecentriq®) or a placebo (no active drug).
  • If Signatera did not find cancer DNA (Signatera-negative): The patient did not get any extra treatment but kept being checked with Signatera every 6 weeks.

This study design helped doctors focus treatment on people who still had cancer left in their body, while avoiding unnecessary treatment for those who didn’t.

What Did the Study Show?

The IMvigor011 study proved that Signatera can help inform who benefits most from treatment after bladder cancer surgery.

For Signatera-Positive Patients

  • Patients who received atezolizumab lived longer and stayed cancer-free longer than those who got placebo.
  • Disease-Free Survival (DFS)*: 9.9 months with atezolizumab vs. 4.8 months with placebo.
  • Overall Survival (OS)**: 32.8 months with atezolizumab vs. 21.1 months with placebo.

These results show that immunotherapy works best for patients who still have small signs of cancer in their blood as identified by Signatera.

For Signatera-Negative Patients

People who remained Signatera-negative had excellent outcomes even without extra treatment:

  • 95% were cancer-free after 1 year
  • 88% were cancer-free after 2 years

This means many patients may be safely monitored instead of receiving unnecessary treatment.

Disease-Free Survival (DFS)*:

How long patients stay free of cancer after treatment. It measures the time until the cancer comes back or the person passes away.

Overall Survival (OS)**:

How long patients live after starting treatment, no matter the cause.

Why is This Important?

IMvigor011 is the first study to prove that a blood test can guide cancer treatment decisions after surgery. With Signatera, doctors can:

  • Treat the right patients at the right time
  • Avoid overtreatment in patients who are already cured
  • Expand the “adjuvant window”: Meaning doctors can safely wait and start therapy only if cancer DNA appears later

What is ctDNA?

ctDNA stands for circulating tumor DNA. These are tiny pieces of cancer DNA that can be found in the blood after surgery or treatment. Finding ctDNA can be an early sign that cancer might come back.

What Is Signatera™?

Signatera™ is a personalized blood test made for each person’s unique tumor DNA. It can detect molecular residual disease (MRD)—tiny amounts of cancer that scans can’t see. Your doctor can use Signatera to:

  • Monitor for early signs of cancer returning
  • Decide whether you may benefit from additional treatment
  • Track how you’re responding to therapy over time

Talk with your doctor to see if Signatera™ is right for you . To learn more about Signatera testing, please visit: Signatera™ Patients . For more detailed information about Signatera testing for Bladder Cancer Survivors, please explore: Signatera™ for GU Cancers .