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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 months
Awards & highlights
CheckMate 9ER Trial 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.Check my eligibility
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.See study design
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.
CheckMate 9ER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer cannot be cured with surgery or radiation.
CheckMate 9ER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Number of Deaths
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
+5 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
CheckMate 9ER 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
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,127,813 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
18,850 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,822 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active cancer spread to my brain.I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.You have any ongoing or suspected autoimmune disease.My kidney cancer cannot be cured with surgery or radiation.I have not received a live vaccine in the last 30 days.My kidney cancer has been confirmed to have clear-cell features.I had one treatment for kidney cancer that didn't target blood vessel growth, and my cancer returned 6+ months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy
- Group 2: Doublet
- Group 3: Triplet
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.
Would it be possible for me to enroll in this research project?
"This particular clinical trial is no longer enrolling patients. The trial was first posted on 8/22/2017 and was last edited on 10/19/2022. However, there are 2655 other clinical trials for carcinoma and 911 for Nivolumab that are still recruiting patients."
Answered by AI
Is this trial taking place at several different hospitals in the United States?
"Sixty patients are being recruited from Local Institution - 0086 in Newnan, Local Institution - 0067 in Portland, Local Institution - 0090 in Redondo Beach, as well as 60 other sites."
Answered by AI
What diseases or conditions is Nivolumab commonly used to treat?
"Nivolumab is the standard-of-care for malignant neoplasms. Nivolumab has also been shown to be an effective treatment for unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."
Answered by AI
Could you walk me through the previous research on Nivolumab?
"Nivolumab was first studied in 2006 at University of Texas MD Anderson Cancer Center. Since the initial research, there have been 644 completed studies. At the moment, there are 911 active trials, with a high concentration in Newnan, Georgia."
Answered by AI
How does Nivolumab compare in danger to other treatments?
"There is both efficacy and safety data from previous trials to support Nivolumab, giving it a score of 3."
Answered by AI
How many willing individuals are participating in this clinical trial?
"Unfortunately, this cancer treatment clinical trial is not currently looking for new patients. The original posting was on August 22nd, 2017, with the most recent edit on October 19th, 2022. If you are interested in other options, there are 2655 trials for carcinoma and 911 trials for Nivolumab that are currently admitting patients."
Answered by AI
What makes this particular trial novel?
"644 studies related to Nivolumab have completed since the initial 2006 trial. The initial Phase 2 drug approval trial, sponsored by Pfizer, included 64 participants. Currently, there are 911 live studies for Nivolumab across 2712 cities and 55 countries."
Answered by AI
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