Trial Outcomes & Findings for Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer (NCT NCT03914300)
NCT ID: NCT03914300
Last Updated: 2025-11-14
Results Overview
Defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy.
ACTIVE_NOT_RECRUITING
PHASE2
11 participants
Up to 6 months after initiation of therapy
2025-11-14
Participant Flow
Participant milestones
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=11 Participants
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Region of Enrollment
United States
|
11 participants
n=10 Participants
|
|
Age, Continuous
|
69 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after initiation of therapyPopulation: One participant was not evaluable for response as they experienced a grade 5 SAE before the first radiographic assesment
Defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=10 Participants
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Objective Response Rate
|
0.1 proportion of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsAssessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Treatment related adverse events that occurred in \>20% of participants are reported here.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=11 Participants
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Muscle cramp
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Nausea
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : White blood cells decreased
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Hypokalemia
|
4 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Abdominal Pain
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Alanine aminotransferase increased
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Anemia
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Anorexia
|
4 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Aspartate aminotransferase increased
|
5 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Diarrhea
|
5 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Dysgeusia
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Fatigue
|
4 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Hypertension
|
4 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Hypoalbuminemia
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Palmar-plantar erythrodysesthesia
|
4 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Rash maculopapular
|
5 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : Weight loss
|
4 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade 1-2 TRAEs : White blood cells decreased
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Abdominal Pain
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Alanine aminotransferase increased
|
1 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Anemia
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Anorexia
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Aspartate aminotransferase increased
|
1 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Diarrhea
|
1 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Dysgeusia
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Fatigue
|
1 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Hypertension
|
3 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Hypoalbuminemia
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Hypokalemia
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Muscle cramp
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Nausea
|
1 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Palmar-plantar erythrodysesthesia
|
1 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Rash maculopapular
|
0 Participants
|
|
Treatment Related Adverse Events (TRAEs)
Grade ≥ 3 TRAEs : Weight loss
|
0 Participants
|
SECONDARY outcome
Timeframe: From response (PR or CR) to documented progression, assessed up to approximately 25 monthsPopulation: One participant was not evaluable for response as they experienced a grade 5 SAE before the first radiographic assessment
From response (PR or CR) to documented progression
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=10 Participants
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Duration of Response
|
18.6 months
Interval 11.8 to 25.4
|
SECONDARY outcome
Timeframe: From initiation of therapy to documented progression or death, whichever occurs first, assessed up to 2 yearsWill be analyzed using Kaplan-Meier methods, resulting in median survival times with 95% confidence interval (CI).
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=11 Participants
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Progression-free Survival
|
8 months
Interval 3.0 to
Upper threshold of confidence interval not met due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From initiation of therapy to death from any cause, assessed up to 2 yearsWill be analyzed using Kaplan-Meier methods, resulting in median survival times with 95% CI.
Outcome measures
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=11 Participants
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Overall Survival
|
19.2 months
Interval 4.6 to
Upper threshold of confidence interval not met due to insufficient number of participants with events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsWill be summarized using frequency and compared between responders and non-responders using chi-square test or Fisher's exact test, whichever is more appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 weeks after treatment start dateWill be described graphically using boxplots or summary measures (e.g., mean and standard errors) at each time point. Will also explore how changes in these correlative markers may differ based on whether or not the patient achieved a response. To accomplish this, will utilize different plotting characters and colors for responses versus (vs.) not in the graphical analyses to help identify potential patterns, and summarize the changes quantitatively between responders and non-responders. Changes in levels will also be compared between responders and non-responders using two sample t-test or Wilcoxon test if the data is not normally distributed. Linear mixed effect models will also be used to examine the association of biomarkers over the time with the response. Potential confounders (patients' demographics and clinical characteristics) may also be included in the models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 weeks post treatment start dateWill be described graphically using boxplots or summary measures (e.g., mean and standard errors) at each time point. Will also explore how changes in these correlative markers may differ based on whether or not the patient achieved a response. To accomplish this, will utilize different plotting characters and colors for responses vs. not in the graphical analyses to help identify potential patterns, and summarize the changes quantitatively between responders and non-responders. Changes in levels will also be compared between responders and non-responders using two sample t-test or Wilcoxon test if the data is not normally distributed. Linear mixed effect models will also be used to examine the association of biomarkers over the time with the response. Potential confounders (patients' demographics and clinical characteristics) may also be included in the models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2 weeks after starting cabozantinib treatment, 12 weeks post treatment start date, and at the time of disease progressionWill be described graphically using boxplots or summary measures (e.g., mean and standard errors) at each time point. Will also explore how changes in these correlative markers may differ based on whether or not the patient achieved a response. To accomplish this, will utilize different plotting characters and colors for responses vs. not in the graphical analyses to help identify potential patterns, and summarize the changes quantitatively between responders and non-responders. Changes in levels will also be compared between responders and non-responders using two sample t-test or Wilcoxon test if the data is not normally distributed. Linear mixed effect models will also be used to examine the association of biomarkers over the time with the response. Potential confounders (patients' demographics and clinical characteristics) may also be included in the models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 12 weeks post treatment start dateWill be described graphically using boxplots or summary measures (e.g., mean and standard errors) at each time point. Will also explore how changes in these correlative markers may differ based on whether or not the patient achieved a response. To accomplish this, will utilize different plotting characters and colors for responses vs. not in the graphical analyses to help identify potential patterns, and summarize the changes quantitatively between responders and non-responders. Changes in levels will also be compared between responders and non-responders using two sample t-test or Wilcoxon test if the data is not normally distributed. Linear mixed effect models will also be used to examine the association of biomarkers over the time with the response. Potential confounders (patients' demographics and clinical characteristics) may also be included in the models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2 weeks after starting cabozantinib treatment, 12 weeks post treatment start date, and at the time of disease progressionWill be described graphically using boxplots or summary measures (e.g., mean and standard errors) at each time point. Will also explore how changes in these correlative markers may differ based on whether or not the patient achieved a response. To accomplish this, will utilize different plotting characters and colors for responses vs. not in the graphical analyses to help identify potential patterns, and summarize the changes quantitatively between responders and non-responders. Changes in levels will also be compared between responders and non-responders using two sample t-test or Wilcoxon test if the data is not normally distributed. Linear mixed effect models will also be used to examine the association of biomarkers over the time with the response. Potential confounders (patients' demographics and clinical characteristics) may also be included in the models.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2 weeks after starting cabozantinib treatment, 12 weeks post treatment start date, and at the time of disease progressionWill be described graphically using boxplots or summary measures (e.g., mean and standard errors) at each time point. Will also explore how changes in these correlative markers may differ based on whether or not the patient achieved a response. To accomplish this, will utilize different plotting characters and colors for responses vs. not in the graphical analyses to help identify potential patterns, and summarize the changes quantitatively between responders and non-responders. Changes in levels will also be compared between responders and non-responders using two sample t-test or Wilcoxon test if the data is not normally distributed. Linear mixed effect models will also be used to examine the association of biomarkers over the time with the response. Potential confounders (patients' demographics and clinical characteristics) may also be included in the models.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
Serious adverse events
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=11 participants at risk
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Alanine Aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Altered Mental Status
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Aspartate Aminotransferase increased
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Cardiac troponin increased
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Delirium
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Diastolic Heart Failure
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Gamma-Glutamyl Transferase (GGT) Increased
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Hepatitis
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
27.3%
3/11 • Number of events 5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Myocardial infarction
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Myocarditis
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Treatment (Cabozantinib S-malate, Nivolumab, Ipilimumab)
n=11 participants at risk
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.
Biospecimen Collection: Undergo blood sample collection
Cabozantinib S-malate: Given PO
Computed Tomography: Undergo CT
Ipilimumab: Given IV
Magnetic Resonance Imaging: Undergo MRI
Nivolumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
3/11 • Number of events 7 • Up to 2 years
|
|
Endocrine disorders
Adrenal insufficiency
|
9.1%
1/11 • Number of events 37 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
36.4%
4/11 • Number of events 25 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
27.3%
3/11 • Number of events 27 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
1/11 • Number of events 12 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
45.5%
5/11 • Number of events 30 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
45.5%
5/11 • Number of events 52 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
54.5%
6/11 • Number of events 39 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Axillary hydrandenitis suppurativa
|
9.1%
1/11 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
3/11 • Number of events 9 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
18.2%
2/11 • Number of events 4 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
18.2%
2/11 • Number of events 3 • Up to 2 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
36.4%
4/11 • Number of events 24 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
18.2%
2/11 • Number of events 7 • Up to 2 years
|
|
Metabolism and nutrition disorders
Calcium decreased-intermittent
|
9.1%
1/11 • Number of events 5 • Up to 2 years
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
27.3%
3/11 • Number of events 12 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
3/11 • Number of events 4 • Up to 2 years
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Number of events 3 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
54.5%
6/11 • Number of events 54 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 7 • Up to 2 years
|
|
Eye disorders
Dry eye
|
9.1%
1/11 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Number of events 5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
1/11 • Number of events 5 • Up to 2 years
|
|
Nervous system disorders
Dygeusia
|
27.3%
3/11 • Number of events 21 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.4%
4/11 • Number of events 6 • Up to 2 years
|
|
Ear and labyrinth disorders
Ear pain
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Investigations
Electocardiogram QT Corrected interval prolonged
|
9.1%
1/11 • Number of events 4 • Up to 2 years
|
|
General disorders
Fatigue
|
54.5%
6/11 • Number of events 49 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
18.2%
2/11 • Number of events 6 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
General muscular weakness
|
18.2%
2/11 • Number of events 10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.2%
2/11 • Number of events 10 • Up to 2 years
|
|
Investigations
GGT increased
|
27.3%
3/11 • Number of events 11 • Up to 2 years
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 13 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Blood and lymphatic system disorders
Hemoptysis
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
1/11 • Number of events 5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hidrandenitis suppurativa
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
18.2%
2/11 • Number of events 6 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
2/11 • Number of events 11 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
18.2%
2/11 • Number of events 3 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
63.6%
7/11 • Number of events 40 • Up to 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.1%
1/11 • Number of events 23 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.3%
3/11 • Number of events 18 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
2/11 • Number of events 18 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
36.4%
4/11 • Number of events 12 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.2%
2/11 • Number of events 19 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.3%
3/11 • Number of events 7 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.2%
2/11 • Number of events 13 • Up to 2 years
|
|
Endocrine disorders
Hpyophysitis
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Hypopituitarism
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
18.2%
2/11 • Number of events 7 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • Number of events 5 • Up to 2 years
|
|
Investigations
Lipase increased
|
18.2%
2/11 • Number of events 12 • Up to 2 years
|
|
Investigations
Mean cell volume decreased
|
9.1%
1/11 • Number of events 7 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
27.3%
3/11 • Number of events 5 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
27.3%
3/11 • Number of events 12 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.2%
2/11 • Number of events 3 • Up to 2 years
|
|
Cardiac disorders
Myocardial infarction
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
9.1%
1/11 • Number of events 16 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pathway crustiness
|
9.1%
1/11 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Number of events 19 • Up to 2 years
|
|
Nervous system disorders
Neuropathy
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
18.2%
2/11 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
1/11 • Number of events 11 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 12 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • Number of events 21 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
45.5%
5/11 • Number of events 31 • Up to 2 years
|
|
Nervous system disorders
Paresthesia
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
45.5%
5/11 • Number of events 11 • Up to 2 years
|
|
Investigations
Platelet count increased
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
18.2%
2/11 • Number of events 6 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
2/11 • Number of events 6 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
18.2%
2/11 • Number of events 7 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
36.4%
4/11 • Number of events 44 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Investigations
Red blood cell count decreased
|
9.1%
1/11 • Number of events 6 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Serum amylase increased
|
9.1%
1/11 • Number of events 5 • Up to 2 years
|
|
Nervous system disorders
Sinus pain
|
36.4%
4/11 • Number of events 44 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Number of events 5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin rash, bilateral lower legs
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
18.2%
2/11 • Number of events 4 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
9.1%
1/11 • Number of events 3 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Tail bone discomfort
|
9.1%
1/11 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Throat discomfort
|
9.1%
1/11 • Number of events 4 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Investigations
Total protein decreased- intermittent
|
9.1%
1/11 • Number of events 10 • Up to 2 years
|
|
Infections and infestations
Upper Respiratory Infection
|
9.1%
1/11 • Number of events 4 • Up to 2 years
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 4 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 8 • Up to 2 years
|
|
Investigations
Weight loss
|
54.5%
6/11 • Number of events 22 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
27.3%
3/11 • Number of events 5 • Up to 2 years
|
Additional Information
Dr. Bhavana Konda
The Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60