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Tyrosine Kinase Inhibitor

Nivolumab + Cabozantinib for Kidney Cancer (CheckMate 9ER Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
Be older than 18 years old
Must not have
Any active CNS metastases
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will test whether a combination of nivolumab and cabozantinib is safe and effective in treating people with previously untreated advanced or metastatic renal cell carcinoma, compared to sunitinib.

Who is the study for?
This trial is for adults with advanced or metastatic renal cell carcinoma (kidney cancer) who haven't had systemic treatment for it, except possibly one adjuvant therapy that didn't target VEGF. Participants should not have received certain vaccines recently, be on high-dose steroids or other immune-suppressing drugs, have active brain metastases, or any known autoimmune diseases.
What is being tested?
The study is testing the safety and effectiveness of combining Nivolumab (an immunotherapy drug) with Cabozantinib (a medication targeting cancer growth) versus using Sunitinib alone in patients who are facing kidney cancer for the first time without previous treatments.
What are the potential side effects?
Potential side effects include immune-related reactions affecting various organs, fatigue, skin issues, gastrointestinal symptoms like diarrhea and nausea, liver toxicity, hormonal gland problems which could affect hormone levels and blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney cancer cannot be cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have active cancer spread to my brain.
Select...
I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.
Select...
I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Number of Deaths
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
+5 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

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.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: TripletExperimental Treatment1 Intervention
Nivolumab, Ipilimumab, Cabozantinib \*Enrollment to the triplet arm was discontinued by protocol amendment
Group II: DoubletExperimental Treatment2 Interventions
Nivolumab and Cabozantinib
Group III: MonotherapyActive Control1 Intervention
Sunitinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420
Cabozantinib
2020
Completed Phase 2
~2360

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,685 Previous Clinical Trials
4,128,747 Total Patients Enrolled
ExelixisIndustry Sponsor
120 Previous Clinical Trials
19,429 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
95,035 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03141177 — Phase 3
Kidney Cancer Research Study Groups: Monotherapy, Doublet, Triplet
Kidney Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT03141177 — Phase 3
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03141177 — Phase 3
~85 spots leftby Nov 2025
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