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Targeted Therapy
Genetic-Guided Therapy for Kidney Cancer
Phase 2
Recruiting
Led By Brian I Rini, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female >= 18 years of age at the time of informed consent
Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing whether using genetic testing to select the optimal treatment regimen works in treating patients with advanced kidney cancer.
Who is the study for?
Adults with advanced or metastatic clear cell renal cell carcinoma, who haven't had systemic therapy for RCC and have a Karnofsky performance status of >=70%. Participants need measurable lesions per RECIST 1.1, adequate organ function, and must consent to genetic testing of their tumor tissue. Women must not be pregnant and agree to contraception.Check my eligibility
What is being tested?
The trial is testing if genetic testing can help choose better treatment for kidney cancer that has spread. It compares two FDA-approved treatments: one combines two immunotherapies (nivolumab plus ipilimumab) via IV infusions; the other pairs nivolumab infusion with an oral pill (cabozantinib).See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, high blood pressure from cabozantinib, fatigue, skin issues from immunotherapy drugs, liver enzyme changes, and potential complications in patients with existing heart conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am a woman who can still have children and have not had surgery to remove my reproductive organs.
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I am a woman over 45 and have not had a period for 12 months due to menopause.
Select...
My kidney cancer has been confirmed to have clear cells.
Select...
My screening results put me in either Cluster 1/2 or 4/5.
Select...
I am able to care for myself but may not be able to do active work.
Select...
My tumor tissue is suitable for RNA-sequencing, not from bone metastasis.
Select...
I have not received any systemic therapy for kidney cancer before.
Select...
My liver functions within normal limits, except for Gilbert's syndrome.
Select...
My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
My kidney cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (Arm 2)
Heart rate
Secondary outcome measures
Depth of response > 80%
Incidence of immune-related adverse events
Progression free survival
Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (nivolumab, cabozantinib)Experimental Treatment2 Interventions
Patients receive nivolumab IV on day 1 and cabozantinib PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (ipilimumab, nivolumab)Experimental Treatment2 Interventions
INDUCTION: Patients receive ipilimumab and nivolumab IV on day 1. Cycles repeat every 21 days for 4 cycles.
MAINTENANCE: Patients receive nivolumab IV on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Cabozantinib
FDA approved
Ipilimumab
FDA approved
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,879 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,613 Total Patients Enrolled
Brian I Rini, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am currently receiving treatment through an IV for an infection.I have not had major surgery within the last 14 days.I use low-dose steroids or hormone replacement without having an active autoimmune disease.I am a woman who can still have children and have not had surgery to remove my reproductive organs.I am a woman over 45 and have not had a period for 12 months due to menopause.You have at least one tumor that can be measured according to specific guidelines.My kidney cancer has been confirmed to have clear cells.My screening results put me in either Cluster 1/2 or 4/5.I am currently experiencing significant bleeding.I have high levels of protein in my urine.I have had treatment for brain metastases.I have a preexisting abnormal connection between two body parts.My blood pressure is higher than 160/90 mmHg, but I am taking medication for it.I am able to care for myself but may not be able to do active work.I do not have severe heart problems or recent heart attacks.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I do not have wounds that won’t heal.My tumor tissue is suitable for RNA-sequencing, not from bone metastasis.I have not received any systemic therapy for kidney cancer before.I cannot take pills by mouth or have a severe gut problem affecting drug absorption.My liver functions within normal limits, except for Gilbert's syndrome.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.My kidney cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (ipilimumab, nivolumab)
- Group 2: Arm II (nivolumab, cabozantinib)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 recruitment efforts for this research project still underway?
"That is correct. As of October 26th, 2022, this clinical trial was recruiting 54 participants from 1 location across the United States."
Answered by AI
Are there reports of Ipilimumab having negative side effects?
"Ipilimumab's safety is estimated to be a 2. This is due to it being a Phase 2 trial, where there is evidence of some safety but none for efficacy."
Answered by AI
How many people are signing up for this clinical trial?
"That is accurate. The information available on clinicaltrials.gov reveals that the trial is currently looking for participants. This study was originally posted on November 15th, 2020 and was last updated on October 26th, 2020. 1 site is hosting this trial and 54 people are needed to complete it."
Answered by AI
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