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Checkpoint Inhibitor
Immunotherapy + Cabozantinib for Advanced Kidney Cancer
Phase 3
Recruiting
Led By Tian Zhang
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
Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria
Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination treatment for patients with untreated renal cell carcinoma. The usual treatment is immunotherapy with ipilimumab and nivolumab, followed by nivolumab alone. The new treatment adds cabozantinib to nivolumab after initial treatment with ipilimumab and nivolumab. It is not yet known if this new combination treatment is better than the usual treatment.
Who is the study for?
This trial is for adults with advanced kidney cancer that hasn't been treated yet. Participants should have a certain level of physical fitness (Karnofsky performance status >= 70%), measurable disease, and be at an intermediate or poor risk according to specific criteria. They can't join if they've had certain treatments before, have active autoimmune diseases, uncontrolled conditions like hypertension or infections like HIV with detectable viral load, or are pregnant.Check my eligibility
What is being tested?
The study compares standard immunotherapy treatment using Nivolumab and Ipilimumab followed by Nivolumab alone versus the same regimen followed by a combination of Nivolumab with Cabozantinib. The goal is to see if adding Cabozantinib improves outcomes in untreated renal cell carcinoma that has spread.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, high blood pressure from Cabozantinib, fatigue, liver enzyme changes, digestive issues such as diarrhea from Ipilimumab and skin problems. Each patient may experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer is classified as intermediate or poor risk.
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My cancer has spread and can be measured by scans.
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I am at intermediate or poor risk for kidney cancer according to specific health criteria.
Select...
My cancer has spread and can be measured by scans.
Select...
I have not been treated with PD-1, PD-L1, or CTLA-4 inhibitors.
Select...
I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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My kidney cancer diagnosis includes clear cell characteristics.
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It has been less than 80 days since my last ipilimumab/nivolumab dose.
Select...
I have not had any systemic therapy for kidney cancer.
Select...
I am able to care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Complete response (CR) (randomized patients)
Incidence of adverse events
Objective response
+2 moreOther outcome measures
Estimates of OS by ethnicity
Estimates of OS by race
Estimates of OS by sex
Side effects data
From 2022 Phase 2 trial • 45 Patients • NCT0210173695%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
VOMITING
41%
NAUSEA
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PAIN
32%
PROTEINURIA
27%
ABDOMINAL PAIN
27%
White Blood Cell Count Decreased
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
18%
HYPOPHOSPHATEMIA
18%
HYPOKALEMIA
18%
Alopecia
18%
Hyperkalemia
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
14%
BILIRUBIN INCREASED
14%
DIZZINESS
14%
Pruritis
14%
ACNEIFORM RASH
14%
Fever
14%
Rash Maculopapular
14%
CONSTIPATION
14%
HYPERGLYCEMIA
14%
HYPOGLYCEMIA
14%
Blood Bilirubin Increased
14%
Cough
14%
Rash Acneiform
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
9%
TUMOR PAIN
9%
ORAL PAIN
9%
ALKALINE PHOSPHATASE INCREASED
9%
WEIGHT GAIN
9%
NASAL CONGESTION
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
LYMPHOCYTE COUNT DECREASED
9%
HYPOCALCEMIA
9%
DRY SKIN
9%
Back Pain
9%
Creatinine Increased
9%
Papulopustular Rash
9%
Paresthesia
5%
RASH
5%
Hoarseness
5%
INSOMNIA
5%
Peripheral Sensory Neuropathy
5%
HYPERTHYROIDISM
5%
Hypertension
5%
ANXIETY
5%
Sore Throat
5%
Myalgia
5%
SPINAL CORD COMPRESSION
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Peripheral Motor Neuropathy
5%
Investigations - Other, Eosinophilia
5%
SINUS BRADYCARDIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Stomach Pain
5%
HEMATURIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
TENDONITIS
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Facial Pain
5%
HYPOMAGNESEMIA
5%
Allergic Rhinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Leg Pain
5%
Muscle Weakness Lower Limb
5%
Muscle Weakness Upper Limb
5%
Psychiatric Disorders - Other, Mood Swings
5%
Scalp Lesion
5%
Scalp Pain
5%
Sinus Tachycardia
5%
Sinusitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
Syncope
5%
Tachycardia
5%
Urine Discoloration
5%
JOINT RANGE OF MOTION DECREASED
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
SERUM AMYLASE INCREASED
5%
SKIN INFECTION
5%
HYPOALBUMINEMIA
5%
URINARY FREQUENCY
5%
URINARY URGENCY
5%
Behaviour Disturbance
5%
Breast Pain
5%
Conjunctivitis
5%
Creatine Phosphokinase Increased
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Hypermagnesemia
5%
Hypotension
5%
Infections And Infestations - Other, Covid-19
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Investigations - Other, International Normalized Ration Increased
5%
Laryngitis
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
5%
Neuropathy
5%
Periodontal Disease
5%
Rash Ezcematoid
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
Tooth Infection
5%
Joint Range Of Motion Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (nivolumab, cabozantinib)Experimental Treatment8 Interventions
INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
TREATMENT:
Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity.
Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-CR/non-PD rwith clinical stability eceive nivolumab IV over 30 minutes on day 1 and cabozantinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan, MRI and blood sample collection throughout the study.
Group II: Arm A (nivolumab)Active Control7 Interventions
INDUCTION: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
TREATMENT:
Patients with iuPD with clinical instability receive cabozantinib PO daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity
Patients with iCR receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with non-CR/non-PD with clinical stability receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo CT scan, MRI and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1700
Cabozantinib
2020
Completed Phase 2
~1080
Computed Tomography
2017
Completed Phase 2
~2720
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,924,679 Total Patients Enrolled
Tian ZhangPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had serious stomach or bowel problems in the last 6 months.You have a disease that can be measured according to the study's guidelines.My kidney cancer is classified as intermediate or poor risk.I am currently being treated for an autoimmune disease.Your blood pressure is too high and not under control.You have HIV and your viral load has been detectable within the last 6 months.I haven't taken blood thinners or platelet inhibitors in the last 5 days.Your hemoglobin level is at least 8 grams per deciliter.I do not have active hepatitis B/C or tuberculosis.I have not had major surgery in the last 4 weeks.My cancer has spread and can be measured by scans.My adrenal glands are not working properly and it's not under control.I have not had any serious wounds, ulcers, or bone fractures that haven't healed in the last 28 days.I have lung lesions with cavities or disease in my airways.My cancer is growing into or around major blood vessels.I have not had untreated blood clots in my lungs or legs in the past 6 months.Your liver enzyme levels should not be too high, unless you have cancer spread to your liver.You need to have a certain amount of a type of white blood cell called neutrophils in your blood.I am at intermediate or poor risk for kidney cancer according to specific health criteria.I am not taking immunosuppressive drugs or more than 10 mg of prednisone daily.I haven't had a major heart attack or severe heart failure symptoms in the last 6 months.I have not had a blood clot in an artery in the last 6 months.I haven't had ulcers, inflammatory bowel disease, or malabsorption in the last 28 days.I have had pancreatitis, an organ transplant, or congenital QT syndrome.My cancer has spread and can be measured by scans.I have not been treated with PD-1, PD-L1, or CTLA-4 inhibitors.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal.I am 18 years old or older.My thyroid condition has not been treated.Your heart's electrical activity, measured as QT interval, is longer than 500 milliseconds.You have had a serious allergic reaction to chimeric or humanized antibodies in the past.I am able to care for myself but may not be able to do active work.My kidney cancer diagnosis includes clear cell characteristics.Your kidneys can filter out at least 30 milliliters of creatinine waste per minute.It has been less than 80 days since my last ipilimumab/nivolumab dose.My brain condition is stable and doesn’t require active treatment.My brain condition is stable and doesn't require active treatment.I am experiencing significant side effects from past treatments.I have not had any systemic therapy for kidney cancer.I have not had GI bleeding or coughed up blood in the past 6 months.I have not had significant blood in my urine, vomit, or coughed up blood in the last 3 months.You have a disease that can be measured according to the study's rules.My liver function is moderately to severely impaired.I have not had an irregular heartbeat in the last 6 months.I am able to care for myself but may not be able to do active work.The amount of protein in your urine is not too high.Your platelet count is at least 100,000 per cubic millimeter.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (nivolumab)
- Group 2: Arm B (nivolumab, cabozantinib)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 other examples of Ipilimumab being used in medical research?
"Ipilimumab is being researched in 884 different studies, 97 of which are still actively recruiting patients. This medication is being tested in many different Phase 3 trials in locations all around the world."
Answered by AI
Could you provide a number for how many different hospitals this trial is being done in?
"Patients are currently being accepted at Ascension Providence Hospitals - Southfield in Southfield, Michigan, Lankenau Medical Center in Wynnewood, Pennsylvania, Saint Francis Hospital in Greenville, South carolina, and 100 other hospitals."
Answered by AI
What medical conditions does Ipilimumab help to manage?
"Ipilimumab is frequently used to treat unresectable melanoma and can also help patients with squamous cell carcinoma, high risk of recurrence, and disease."
Answered by AI
What are the odds of having an adverse reaction to Ipilimumab?
"Ipilimumab's phase 3 status indicates that, while there is data supporting its efficacy, there is also extensive data collected on its safety, giving it a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Memorial Hermann Texas Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Other Trials to Consider
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