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Tyrosine Kinase Inhibitor
Axitinib + Nivolumab for Kidney Cancer
Phase 2
Waitlist Available
Led By James I Geller
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
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN for age (performed within 7 days prior to enrollment)
Patients must have a body surface area (BSA) >= 0.53 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial studies a combination of two drugs, axitinib and nivolumab, to see how well they work in treating patients with a certain type of kidney cancer.
Who is the study for?
This trial is for patients with a specific kidney cancer called TFE/translocation renal cell carcinoma that can't be surgically removed or has spread. Participants must meet various health criteria, including proper organ function and blood counts, and not have received certain treatments recently. It's open to individuals as young as one year old who are expected to live at least 8 weeks.Check my eligibility
What is being tested?
The study tests axitinib and nivolumab in treating unresectable or metastatic tRCC. Axitinib blocks enzymes needed for tumor growth, while nivolumab, an immunotherapy drug, helps the immune system attack cancer cells. The goal is to see if this combination works better than standard treatments.See study design
What are the potential side effects?
Possible side effects include high blood pressure from axitinib and immune-related reactions from nivolumab such as inflammation of organs or skin problems. Both drugs may also cause fatigue, liver issues, digestive disturbances, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function tests are within normal limits.
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My body surface area is at least 0.53 square meters.
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It has been over a week since my last biologic treatment.
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My recent blood tests show normal bilirubin levels.
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I have never had a heart attack or severe heart-related issues.
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My cancer can be measured by scans or tests.
Select...
My tumor has specific characteristics and has been tested for TFE3 protein or gene changes.
Select...
My kidney function is within the normal range for my age.
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My platelet count is at least 75,000 and I haven't needed a transfusion.
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My kidney function is within the required range for the study.
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My heart's QT interval is less than 480 msec, and if it's between 450-480 msec, causes have been addressed.
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My blood pressure is within the normal range for my age, height, and gender.
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I have waited the required time after my radiation therapy before joining this trial.
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I am at least 12 months old.
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
Progression free survival
Secondary outcome measures
Incidence of adverse events (AEs)
Overall response rate (ORR)
Overall survival
Other outcome measures
Pharmacokinetics (PK) of axitinib
Translocation morphology renal cell carcinoma clinical behavior
Type of antitumor immune response and stability of T cell activation
Side 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%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
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%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
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%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Hypercalcaemia
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
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
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (nivolumab)Experimental Treatment1 Intervention
Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (axitinib)Experimental Treatment1 Intervention
Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C)
Group III: Arm A (axitinib, nivolumab)Experimental Treatment2 Interventions
Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if < 18 years old) or on day 1 (if >= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
2020
Completed Phase 2
~3050
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,627 Total Patients Enrolled
James I GellerPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
283 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within normal limits.My blood clotting time is normal or managed with medication.I have been treated with more than one anti-VEGF medication.I have not had a stem cell or solid organ transplant.I've been on stable blood pressure medication for over a week.My body surface area is at least 0.53 square meters.I have not had immunotherapy in the last 4 weeks.It has been over a week since my last biologic treatment.My hemoglobin level is at least 8.0 g/dL.My recent blood tests show normal bilirubin levels.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.You cannot participate if you have certain medical conditions including active cancer, immune deficiency, chronic infections, HIV, bleeding or clotting issues, significant vascular disease, pneumonitis, active brain or spinal cord cancer, uncontrolled illness, serious medical or psychiatric condition, or active autoimmune disease requiring medication.My blood clotting time is within the normal range, or if I'm on blood thinners, it's within the therapeutic range.I have never had a heart attack or severe heart-related issues.My cancer can be measured by scans or tests.My tumor has specific characteristics and has been tested for TFE3 protein or gene changes.I haven't had chemotherapy that lowers blood cell counts in the last 2 weeks (or 6 weeks for a specific type).My platelet count is at least 75,000 and I haven't needed a transfusion.My kidney function is within the required range for the study.I cannot swallow whole tablets.I haven't taken drugs that affect nivolumab/axitinib or had a live vaccine recently.My heart's QT interval is less than 480 msec, and if it's between 450-480 msec, causes have been addressed.I have previously been treated with axitinib, nivolumab, or other PD1/PD-L1 inhibitors.I haven't taken any targeted cancer drugs in the last 2 weeks or still have side effects from them.I, or my guardian, have signed the consent form and meet all study requirements.My kidney function is within the normal range for my age.I have recovered from side effects of my previous cancer treatments.I haven't had major surgery or serious injuries in the last 7 days and don't plan major surgery within 12 weeks.My kidney cancer is advanced and cannot be surgically removed.My blood pressure is within the normal range for my age, height, and gender.I have waited the required time after my radiation therapy before joining this trial.I am not allergic to axitinib, nivolumab, or their ingredients.I can take care of myself but may not be able to do active work.I am at least 12 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (nivolumab)
- Group 2: Arm B (axitinib)
- Group 3: Arm A (axitinib, nivolumab)
Awards:
This trial has 1 awards, including:- 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.
What is the prior research on Nivolumab's efficacy?
"Nivolumab was first used in human trials at H. Lee Moffitt Cancer Center and Research Institute in 2010. Since then, there have been a total of 328 completed clinical trials with 790 more currently recruiting patients. A high volume of these studies are based out of Lexington, Michigan."
Answered by AI
What are the primary conditions that Nivolumab is used to address?
"Nivolumab is a medication that is used to treat different types of cancer. It has been known to be effective against melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Do we still have the opportunity to sign up for this research project?
"That is correct. The online information available on clinicaltrials.gov verifies that this particular study, which was initially announced on October 9th 2018, currently has open recruitment and is looking for 40 patients from 100 different sites."
Answered by AI
How many people are included as subjects in this research project?
"That is correct, the clinical trial mentioned is still recruiting patients according to the information found on clinicaltrials.gov. This particular study was posted on October 9th, 2018 and updated November 4th of this year. They are looking for a total of 40 participants that will be spread out across 100 locations."
Answered by AI
Is this research novel in any way?
"Nivolumab has been under scientific scrutiny for a little over a decade. The first clinical trial was sponsored by Medarex and took place in 2010. Only 127 patients were involved in the study. Nivolumab received Phase 1 drug approval after this initial study. As of now, there are 790 active studies being conducted with Nivolumab across 2426 cities and 51 countries worldwide."
Answered by AI
Is this trial being conducted in many hospitals across Canada?
"The trial is based in University of Kentucky/Markey Cancer Center (Lexington, Michigan), C S Mott Children's Hospital (Ann Arbor, Wisconsin), Marshfield Medical Center-Marshfield (Marshfield, New jersey) with other 100 locations."
Answered by AI
What is the percentage of patients who experience side effects from Nivolumab?
"Nivolumab has received a score of 2 from our team at Power. This is because, while there is some evidence indicating that it is safe, there is no data supporting that it works as intended."
Answered by AI
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