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Genetic-Guided Therapy for Kidney Cancer
Study Summary
This trial is testing whether using genetic testing to select the optimal treatment regimen works in treating patients with advanced kidney cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT01285609Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Arm I (ipilimumab, nivolumab)
- Group 2: Arm II (nivolumab, cabozantinib)
- 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.
- 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
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."
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."
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."
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