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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

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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more
Other 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 more

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02315430
85%
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%
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

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
~4740
Biospecimen Collection
2004
Completed Phase 2
~1720
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2610
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for thyroid cancer, such as Cabozantinib, Nivolumab, and Ipilimumab, work through distinct mechanisms that target tumor growth and enhance immune response. Cabozantinib, a tyrosine kinase inhibitor, blocks enzymes necessary for tumor growth and angiogenesis, effectively cutting off the tumor's blood supply. Nivolumab, a PD-1 inhibitor, prevents cancer cells from evading the immune system, allowing T-cells to attack the tumor. Ipilimumab, a CTLA-4 inhibitor, boosts T-cell activation and proliferation, further enhancing the immune response against cancer cells. These targeted therapies are crucial for thyroid cancer patients as they offer more effective and personalized treatment options, potentially improving survival rates and quality of life.
Narrative review of pembrolizumab for the treatment of esophageal cancer: evidence and outlook.Immunotherapies in Early and Advanced Renal Cell Cancer.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,374 Total Patients Enrolled
Bhavana KondaPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03914300 — Phase 2
Thyroid Cancer Research Study Groups: Treatment (cabozantinib S-malate, nivolumab, ipilimumab)
Thyroid Cancer Clinical Trial 2023: Cabozantinib S-malate Highlights & Side Effects. Trial Name: NCT03914300 — Phase 2
Cabozantinib S-malate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03914300 — Phase 2
~1 spots leftby Oct 2024