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Tyrosine Kinase Inhibitor
Cabozantinib + Nivolumab for Endometrial Cancer
Phase 2
Waitlist Available
Led By Stephanie Lheureux
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing cabozantinib and nivolumab to see if they're effective in treating endometrial cancer.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include risks associated with immunotherapies such as inflammation in organs and infusion reactions. There may also be side effects from blocking cell growth enzymes like digestive issues and increased risk of bleeding. The exact side effects will vary between individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Incidence of adverse events
Heart rate
Overall survival (OS)
+1 moreSide effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Sore Throat
15%
Activated Partial Thromboplastin Time Prolonged
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Allergic Rhinitis
8%
Generalized Muscle Weakness
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (nivolumab)Experimental Treatment5 Interventions
Patients receive nivolumab as in Arm A. Patients may cross-over to Arm A at the time of disease progression. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up.
Group II: Arm A (cabozantinib s-malate, nivolumab)Experimental Treatment6 Interventions
Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15, then on day 1 beginning cycle 5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Biopsy
2014
Completed Phase 4
~1090
Nivolumab
2014
Completed Phase 3
~5220
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Cabozantinib S-malate
2013
Completed Phase 2
~470
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,944 Total Patients Enrolled
Stephanie LheureuxPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
5 Previous Clinical Trials
451 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.I am able to care for myself and perform daily activities.You have a sufficient number of a type of white blood cell called neutrophils, with a count of at least 1500/mcL.I have received platinum-based chemotherapy before.My MS/MMR status is known and was tested using a standard method.I have tissue samples available for testing.My condition is advanced, recurrent, or metastatic endometrial cancer.I am 18 years old or older.My kidney function is within the normal range.I haven't had chemotherapy, biologic agents, or radiotherapy in the last 4 weeks.My cancer has spread to my digestive system.I had a tumor biopsy when my cancer progressed after being on Arm B of the study.I have no active cancer other than endometrial cancer.I need medication to prevent blood clots.I am still experiencing side effects from previous cancer treatments.You are currently taking part in any other research studies.I have a large pelvic mass that could lead to abnormal connections or I've had a blocked intestine.I have not received a live vaccine in the last 4 weeks.You have an autoimmune disease that needed treatment within the past two years.I do not have any severe illnesses that are not under control.I cannot swallow pills.I have not had serious bleeding issues recently.My tumor is growing into or around major blood vessels.I have not had major surgery recently.I do not have active HIV, AIDS-related illnesses, or hepatitis B/C.I have an immune system disorder or am on medication that weakens my immune system.You have a mental health condition or social situation that could make it difficult for you to follow the study requirements.You are currently pregnant or breastfeeding.I have had platinum-based chemotherapy before for my cancer.I have lung lesions with cavities.My latest treatment didn't stop my cancer from growing.I have previously received treatment targeting my immune system.My cancer is a type of endometrial carcinoma confirmed by lab tests.I can take care of myself and perform daily activities.My condition allows for a biopsy and I agree to have one.I have cancer that has spread to my brain.I am not on any strong medication that affects liver enzyme levels.You are not currently breastfeeding a baby.I have been treated with cabozantinib before.I am not allergic to cabozantinib or nivolumab.You must have a measurable tumor that can be evaluated using RECIST v1.1 criteria.My latest scans show my cancer has grown since my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (cabozantinib s-malate, nivolumab)
- Group 2: Arm B (nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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