All studies
Active not recruitingPHASE2INTERVENTIONAL

Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer

This research is a 'Phase 2' study exploring new ways to treat advanced endometrial cancer. This is cancer that has returned or spread to other parts of the body. The study aims to find out if a combination of two drugs, cabozantinib and nivolumab, is more effective than nivolumab on its own. Cabozantinib works by blocking certain pathways that cancer cells need to grow, while nivolumab helps your body's own immune system fight the cancer. Researchers hope that using these treatments together will be better at controlling the cancer and improving patients' health. Patients involved in this study would have already received at least one course of platinum-based chemotherapy. If successful, this combination could offer a new treatment option.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Enrolment target
82
Start
16 Apr 2018
Estimated completion
23 Jul 2026

Results

Results from this study

Posted April 2026

Results have been published for this study.

Primary outcome
Progression Free Survival (PFS)
PFS is defined as the interval between randomization and disease progression or death from any cause, which ever occurred earlier.
Full results on the registry

What is this study about?

This study is looking into new treatments for a type of cancer that starts in the lining of the womb, called endometrial cancer. Specifically, it focuses on cancer that has either come back after treatment (recurrent), or has spread to other parts of the body (advanced or metastatic). These types of cancer can be challenging to treat, and researchers are always looking for better options. This study wants to see if combining two different medications might offer a more effective approach.

The two medicines being tested are called cabozantinib and nivolumab. Cabozantinib is a drug that works by blocking certain signals inside cancer cells that they need to grow and spread. Think of it like putting a stop sign on the cancer's growth pathway. Nivolumab is an immunotherapy drug. This means it helps your own body's immune system, which is usually very good at fighting off invaders, to recognise and attack the cancer cells more effectively. It essentially 'wakes up' the immune system to fight the cancer.

The main goal of this study is to compare how well patients do when they receive both cabozantinib and nivolumab, versus those who receive nivolumab on its own. Researchers will be looking at how long the cancer is kept under control (this is called 'progression-free survival') and whether the cancer shrinks. They will also look at how long people live overall, and closely monitor any side effects to make sure the treatment is as safe as possible. By better understanding how these drugs work together, doctors hope to find improved treatments for endometrial cancer.

Key takeaways

  • This study is for endometrial cancer that has returned or spread.
  • It tests if two drugs (cabozantinib and nivolumab) are better than one (nivolumab alone).
  • Cabozantinib targets cancer growth, while nivolumab helps your immune system fight the cancer.
  • You would need to have had previous platinum-based chemotherapy.
  • Participation involves regular visits, blood tests, and scans.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you would need to have endometrial cancer that has either come back or spread to other parts of your body. Doctors must have confirmed this cancer using a biopsy. You also need to show that your cancer has grown after your most recent treatment, and doctors must be able to measure your cancer using scans.

Before considering this study, you would need to have already received at least one course of chemotherapy treatment that contained a drug called platinum. The good news is that previous hormone therapy, other targeted treatments, or radiotherapy usually won't stop you from joining. You must be at least 18 years old and in generally good health, meaning you can carry out most of your usual daily activities. Your blood test results, like your liver function and blood cell counts, would also need to be within a healthy range.

There are also specific details your doctor will check regarding your tumour, such as its 'microsatellite instability (MSI)' status, which helps guide treatment decisions. The research team would need to be able to get a sample of your tumour tissue that was taken previously, for further analysis.

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. Do I have endometrial cancer that has come back or spread?
  2. Has my cancer grown since my last treatment?
  3. Have I already received at least one course of platinum-based chemotherapy?
  4. Am I at least 18 years old?
  5. Am I generally well enough to do most of my daily activities?
  6. Do I have recent CT or MRI scans that can measure my cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is a randomisation process, like flipping a coin, to decide which treatment group you'll be in. You'll either receive both cabozantinib and nivolumab, or nivolumab on its own. Cabozantinib is a tablet you take by mouth once a day. Nivolumab is given through a drip into your vein (intravenously) over about 30 minutes, usually on specific days during a treatment cycle.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and to receive your treatment. You'll also have scans, like CT scans or MRI scans, to see how your cancer is responding to the treatment. These scans might be done at the start and then periodically during your treatment. The study team will explain the exact schedule of visits and tests to you in detail.

The total duration of your participation would depend on how your body responds to the treatment. You would continue treatment for as long as it is benefiting you and you are tolerating it well. You'll be closely monitored for any side effects and your general health throughout the study.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by medical experts. While this study hopes the combination treatment will be more effective, there's no guarantee the treatment will work for you. As with all medications, there are potential risks, and you may experience side effects from the drugs. The study team will explain all known side effects and help manage any that you experience. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (34)

  • Mayo Clinic Hospital in Arizona
    Verified postcode
    Phoenix, United States
  • Mayo Clinic in Arizona
    Verified postcode
    Scottsdale, United States
  • City of Hope Comprehensive Cancer Center
    Verified postcode
    Duarte, United States
  • UC San Diego Moores Cancer Center
    Verified postcode
    La Jolla, United States
  • Los Angeles General Medical Center
    Verified postcode
    Los Angeles, United States
  • USC / Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States
  • University of California Davis Comprehensive Cancer Center
    Verified postcode
    Sacramento, United States
  • UF Health Cancer Institute - Gainesville
    Verified postcode
    Gainesville, United States
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States
  • Northwestern University
    Verified postcode
    Chicago, United States
  • University of Chicago Comprehensive Cancer Center
    Verified postcode
    Chicago, United States
  • UC Comprehensive Cancer Center at Silver Cross
    Verified postcode
    New Lenox, United States

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). This study focuses on cancer that has spread or come back.

What do 'advanced' or 'metastatic' mean?

These terms mean the cancer has spread from where it started to other parts of the body.

What are cabozantinib and nivolumab?

Cabozantinib is a tablet that blocks cancer cell growth. Nivolumab is a drip treatment that helps your immune system fight the cancer.

Will I definitely get the new combination treatment?

No, you'll be randomly assigned to receive either the combination of both drugs or nivolumab alone, like flipping a coin.

Can I stop the study if I want to?

Yes, you can leave the study at any time, for any reason. It won't affect your regular medical care.

How to find out more

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

Discussion

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