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Tyrosine Kinase Inhibitor
Cabozantinib + Nivolumab + Ipilimumab for Thyroid Cancer
Phase 2
Waitlist Available
Led By Bhavana Konda
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 2 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs to treat patients with a specific type of thyroid cancer.
Who is the study for?
Adults with advanced differentiated thyroid cancer that's resistant to radioactive iodine and has worsened after VEGFR-targeted therapy. They must have measurable disease, not be pregnant, agree to use contraception, and be able to swallow pills. Excludes those with certain other cancers within the last 2 years or specific health conditions.Check my eligibility
What is being tested?
The trial is testing a combination of three drugs: Cabozantinib (blocks enzymes for cell growth), Nivolumab, and Ipilimumab (both boost the immune system against cancer). It aims to see if this trio is more effective than standard chemotherapy treatments for this type of thyroid cancer.See study design
What are the potential side effects?
Potential side effects include diarrhea, high blood pressure, fatigue, liver issues like hepatitis, mouth sores, hand-foot syndrome (redness and pain in hands/feet), hormone gland problems (like thyroid dysfunction), skin rash or itching.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Secondary outcome measures
Duration of response
Incidence of adverse events (AEs)
Overall survival
+1 moreOther outcome measures
Circulating myeloid-derived suppressor cells
PD-1/PD-L1 expression in the primary/metastatic tumor in biopsies
Peripheral blood mononuclear cell (cell)
+4 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%
Activated Partial Thromboplastin Time Prolonged
15%
Sore Throat
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%
Generalized Muscle Weakness
8%
Allergic Rhinitis
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib S-malate, nivolumab, ipilimumab)Experimental Treatment6 Interventions
Patients receive cabozantinib S-malate PO QD on days -14 to -1 prior to cycle 1, days 1-42 of cycles 1-4 and days 1-28 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1, 15, and 29 of cycles 1-4 and day 1 of subsequent cycles and ipilimumab IV over 90 minutes on day 1 of cycles 1-4. Treatment repeats every 42 days for cycles 1-4 and every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI during screening, and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Biospecimen Collection
2004
Completed Phase 2
~1730
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2620
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,263 Total Patients Enrolled
Bhavana KondaPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
1 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any medications that are not allowed in the study.I have someone legally authorized to make decisions for me due to my impaired decision-making capacity.I have HIV, am on treatment, and my viral load is undetectable.My cancer has not spread to major blood vessels or the GI tract.I do not have untreated brain or spinal cord cancer spread.My heart's electrical activity is normal as per my recent EKG.I do not have any severe, uncontrolled illnesses.I do not have an active autoimmune disease or a history of one that could come back and affect my vital organs or require treatment to suppress my immune system.My thyroid cancer does not respond to radioactive iodine treatment.My cancer has worsened despite treatment targeting blood vessel growth.It's been over 4 weeks since my last cancer treatment.I have chronic hepatitis B but it's under control with treatment.My blood, liver, kidney, and metabolic health meet the trial's requirements.I haven't had certain treatments recently.I am 18 years old or older.I have not taken specific medications for my condition.I haven't been diagnosed with another cancer type in the last 2 years.My thyroid cancer is confirmed as PTC, FTC, HTC, or a specific variant but not ATC or MTC.Patients must have a measurable disease according to specific guidelines.I have recovered from previous treatment side effects, or they are minor and stable.I can swallow pills.I can take care of myself but might not be able to do heavy physical work.I had hepatitis C but have been treated and cured.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cabozantinib S-malate, nivolumab, ipilimumab)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants in this clinical experiment?
"This medical experiment is no longer recruiting participants as it was last updated on November 29th, 2022. However, if you are still searching for trials to join, there are currently 2650 studies enlisting candidates suffering from carcinoma papillary and 841 clinical trials involving cabozantinib s-malate that require volunteers."
Answered by AI
What safety protocols are in place to protect patients taking Cabozantinib S-malate?
"Cabozantinib S-malate is graded as a 2 on our safety scale, which signifies that patient safety has been partially established through clinical data but efficacy remains unproven."
Answered by AI
Are there any other research projects that have explored the effects of Cabozantinib S-malate?
"Initially tested at Texas Children's Hospital in 2009, cabozantinib S-malate has since been subject to 418 clinical trials and is currently being trialed on 841 occasions. A majority of these medical experiments are occurring in Columbus, Ohio."
Answered by AI
How widely available is the trial in North America?
"This trial currently has 33 enrollees, with Ohio State University Comprehensive Cancer Center in Columbus, University of Kentucky/Markey Cancer Center in Lexington and Memorial Sloan Kettering Nassau located in Uniondale being some of them. An additional 30 locations are also participating."
Answered by AI
For what clinical applications is Cabozantinib S-malate typically prescribed?
"Unresectable melanoma, squamous cell carcinoma, and cases with a high probability of relapse can all be managed through the use of Cabozantinib S-malate."
Answered by AI
What is the total participant count for this investigation?
"At the moment, this clinical trial has ceased to enrol patients. First posted on July 15th 2019 and updated for a final time on November 29th 2022, there are no opportunities in this particular research initiative. However, those looking for alternate trials can find 2650 studies pertaining to carcinoma papillary actively recruiting participants as well 841 trials involving cabozantinib s-malate that accept new volunteers."
Answered by AI
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