84 Participants Needed

Cabozantinib + Nivolumab for Endometrial Cancer

Recruiting at 36 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase II trial studies how well cabozantinib s-malate and nivolumab work in treating patients with endometrial cancer that has come back (recurrent) or spread to other places in the body (advanced or metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may work better in treating endometrial cancer.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are on certain medications like strong CYP450 3A4 inducers or inhibitors, and those requiring therapeutic doses of anticoagulants. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is the combination of Cabozantinib and Nivolumab safe for humans?

The safety of Cabozantinib and Nivolumab in humans has been explored in various studies, but specific safety data for this combination in endometrial cancer is not detailed in the provided research. However, Cabozantinib and Nivolumab have been studied separately and in combination with other drugs, showing some common side effects like high blood pressure, fatigue, and nausea.12345

How is the drug combination of Cabozantinib and Nivolumab unique for treating endometrial cancer?

This drug combination is unique because it combines an immunotherapy drug (nivolumab) with an antiangiogenic agent (cabozantinib), which targets blood vessel growth in tumors. This approach is promising for endometrial cancer, especially for patients who have not responded to previous immunotherapy treatments.13678

What data supports the effectiveness of the drug combination Cabozantinib and Nivolumab for endometrial cancer?

The combination of Cabozantinib and Nivolumab is being explored as a promising treatment strategy for endometrial cancer, as combining immunotherapy (like Nivolumab) and antiangiogenic agents (like Cabozantinib) has shown potential in treating this type of cancer. Additionally, PD-1 inhibitors, which include Nivolumab, have demonstrated activity in endometrial cancer, particularly in cases with certain genetic features.178910

Who Is on the Research Team?

Dr. Stéphanie Lheureux | Bras DDP

Stephanie Lheureux

Principal Investigator

University Health Network Princess Margaret Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for adults with advanced, recurrent, or metastatic endometrial cancer who've had at least one platinum-based chemotherapy. They must have measurable disease progression and not be on certain medications or have conditions like uncontrolled illnesses, other active cancers, known brain metastases, or a history of severe allergic reactions to the study drugs.

Inclusion Criteria

My cancer is in an advanced stage, has come back, or has spread from where it started.
I have been diagnosed with endometrial cancer.
MS/MMR result available at time of registration
See 26 more

Exclusion Criteria

I haven't had chemotherapy, biologic agents, or radiotherapy in the last 4 weeks.
My cancer has spread to my digestive system.
I have no active cancer other than endometrial cancer.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Patients receive cabozantinib s-malate and nivolumab or nivolumab alone, with cycles repeating every 28 days

Up to 1 year
Bi-weekly visits for nivolumab administration, monthly for cabozantinib

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-37 days, then every 8-12 weeks
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Cabozantinib S-malate
  • Nivolumab
Trial Overview The trial is testing the combination of Cabozantinib S-malate (a drug that blocks enzymes needed for tumor growth) and Nivolumab (an immunotherapy that helps the immune system attack cancer). It aims to see if this combo is more effective than current treatments in patients whose endometrial cancer has returned or spread.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm B (nivolumab)Experimental Treatment5 Interventions
Group II: Arm A (cabozantinib s-malate, nivolumab)Experimental Treatment6 Interventions

Cabozantinib S-malate is already approved in United States, European Union for the following indications:

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Approved in United States as Cabometyx for:
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Approved in United States as Cometriq for:
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Approved in European Union as Cabometyx for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a phase II trial involving women with recurrent endometrial cancer, the combination of nivolumab and cabozantinib significantly improved progression-free survival (PFS) to a median of 5.3 months compared to 1.9 months for nivolumab alone, indicating enhanced efficacy of the combination therapy.
The study identified specific immune cell profiles that may predict treatment response, particularly in patients previously treated with immunotherapy, suggesting that immune profiling could help tailor future treatments.
Translational randomized phase II trial of cabozantinib in combination with nivolumab in advanced, recurrent, or metastatic endometrial cancer.Lheureux, S., Matei, DE., Konstantinopoulos, PA., et al.[2023]
The phase III RUBY and NRG-GY018 trials demonstrated that women with newly diagnosed or first-recurrent advanced endometrial cancer benefit from combining a PD-1 inhibitor (dostarlimab or pembrolizumab) with standard chemotherapy.
This combination treatment significantly prolonged progression-free survival, and there was a positive trend in overall survival, indicating its potential effectiveness in managing this type of cancer.
ICI-Chemo New Standard for Endometrial Cancer.[2023]
PD-1 and PD-L1 inhibitors have shown effectiveness in treating ovarian, endometrial, and cervical cancers, particularly in cases of mismatch repair-deficient endometrial cancers, which exhibit the highest response rates.
Testing for mismatch repair deficiency or high microsatellite instability is recommended for all women with progressive gynecologic cancers to determine eligibility for treatment with pembrolizumab, a PD-1 inhibitor.
The Role of PD-1 Checkpoint Inhibition in Gynecologic Malignancies.Garcia, C., Ring, KL.[2022]

Citations

Translational randomized phase II trial of cabozantinib in combination with nivolumab in advanced, recurrent, or metastatic endometrial cancer. [2023]
ICI-Chemo New Standard for Endometrial Cancer. [2023]
The Role of PD-1 Checkpoint Inhibition in Gynecologic Malignancies. [2022]
Uterine serous carcinoma. [2022]
Management of Metastatic Endometrial Cancer: Physicians' Choices Beyond the First Line. A MITO Survey. [2022]
Optimizing the use of lenvatinib in combination with pembrolizumab in patients with advanced endometrial carcinoma. [2023]
Anticancer Activity of the Combination of Cabozantinib and Temozolomide in Uterine Sarcoma. [2022]
Characterization and Management of Adverse Reactions in Patients with Advanced Endometrial Carcinoma Treated with Lenvatinib Plus Pembrolizumab. [2022]
Characterization and Management of Adverse Reactions in Patients With Advanced Endometrial Cancer Receiving Lenvatinib Plus Pembrolizumab. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase II Trial of Cabozantinib in Recurrent/Metastatic Endometrial Cancer: A Study of the Princess Margaret, Chicago, and California Consortia (NCI9322/PHL86). [2021]
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