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Nivolumab + Axitinib for Kidney Cancer
Study Summary
This trial is testing a combination of drugs to treat advanced renal cell carcinoma in both previously treated and untreated patients. The first part of the trial will establish a safe and tolerable dose, and the second part will test the efficacy of the combination at that dose.
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 2019 Phase 2 trial • 13 Patients • NCT02129647Trial Design
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Who is running the clinical trial?
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- I have active brain or spinal cord cancer symptoms.My bone marrow, kidney, and liver are functioning well.I haven't taken steroids or immunosuppressants in the last 14 days.I have no major issues with my digestive system.You have a wound that is not healing properly.I am aware that my treatment may affect my liver.I am older than 18 years.I have received specific treatments for my metastatic disease or was treated with high dose interleukin-2.I have advanced kidney cancer and haven't received any systemic therapy for it.I have had heart problems in the last year.I have been diagnosed with an immune system disorder.I have had a blood clot in my veins or lungs in the last 6 months.I haven't had major surgery in the last 4 weeks or radiation therapy in the last 2 weeks.I have an autoimmune disease, but it's not one of the exceptions listed.I am currently receiving treatment for another cancer.I am using or might need strong CYP3A4/5 inducer drugs.If there are stored tumor samples, they will be used for further testing. If there are no stored samples, you can still participate in the study.I haven't had significant bleeding or a bleeding disorder in the last 30 days.You have at least one specific type of visible abnormality that can be measured according to a particular set of guidelines.I have been diagnosed with HIV/AIDS.My kidney cancer is mainly of the clear cell type.Your high blood pressure is not under control.I haven't had cancer treatment or radiation in the last 14 days.I can provide tissue samples from a cancer spread site for testing.I have been treated with axitinib before.I am fully active or can carry out light work.I am using or might need strong CYP3A4/5 inhibitors.I have hepatitis B or C.
- Group 1: Phase II patients: cohort 1
- Group 2: Phase I patients
- Group 3: Phase II patients: cohort 2
- 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
What are the groundbreaking aspects of this research?
"Axitinib has been researched since 2010 when the first trial was conducted by Medarex. 127 people participated in this initial study which resulted in Axitinib receiving Phase 1 drug approval. Currently, there are 796 active trials involving Axitinib taking place across 2437 cities and 51 countries."
Can people still join this clinical trial?
"Yes, this study is currently looking for participants. According to the clinicaltrials.gov website, the posting for this trial went up on June 12th, 2017 and was updated on November 16th, 2021."
Are there multiple research facilities within the United States conducting this trial?
"Currently, this experiment is being conducted in 4 locations, which are situated in New york, Baltimore, Philadelphia, and _____. If you are selected as a participant, it would be best if you chose a location close to you to cut down on travel."
What is Axitinib's most common usage?
"Oncologists often prescribe axitinib to their patients suffering from malignant neoplasms. Additionally, this medication can be used as part of the treatment plan for unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
What are the expectations for this experiment?
"The primary goal of this study, which will take up to 12 months, is to document the frequency of adverse events related to the treatment. Additionally, the research team will analyze patient samples to look for PD-L1 expression and tumor infiltrating lymphocytes. Lastly, the study will assess the safety of the treatment by summarizing the type, frequency, and severity of any adverse events."
Are there any other Axitinib studies that have already been conducted?
"Axitinib is being studied in 796 active clinical trials, 87 of which are in Phase 3. Although many Axitinib trials are based in Mexico City and Maryland, there are a total of 41163 locations running studies for the medication."
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