Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
SLM-Axitinib-Pembrolizumab for Renal Cell Carcinoma
Phase 1 & 2
Recruiting
Led By Yousef Zakharia, MD
Research Sponsored by Yousef Zakharia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of childbearing potential and non-sterilized male subjects who intend to be sexually active during the study must agree to use a highly effective method of contraception from the time of screening, throughout the total duration of the drug treatment, and during the 6 month post-drug washout period. See section 5.6 for full details
Liver function (AST/ALT <3.0 X institutional upper limit of normal OR < 5 x institutional upper limit of normal in cases of liver metastases; Total bilirubin ≤ 1.5 times ULN)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the initiation of treatment through three years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it is safe and effective for patients with advanced kidney cancer.
Who is the study for?
This trial is for adults with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who haven't been treated for it in the metastatic setting. They must be physically active or able to do light work, have normal organ function, controlled blood pressure, and agree to use effective contraception. Those with other cancers, untreated brain metastases, recent major surgery, HIV/AIDS complications, or needing certain drugs are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Seleno-L Methionine (SLM) combined with standard doses of Axitinib and Pembrolizumab in treating ccRCC. It aims to see if adding SLM improves outcomes compared to just Axitinib and Pembrolizumab.See study design
What are the potential side effects?
Possible side effects include typical reactions from cancer treatments such as fatigue, nausea, liver issues; immune-related conditions due to Pembrolizumab; high blood pressure from Axitinib; plus any unique effects from combining these with SLM.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use effective birth control during and 6 months after the study.
Select...
My liver tests are within the required limits, even with liver metastases.
Select...
I can do my usual activities or light work but not heavy physical tasks.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
I am older than 18 years.
Select...
I have a tumor that can be measured and hasn't been treated with radiation.
Select...
My blood pressure is ≤150/90 mm Hg and stable on my current medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the initiation of treatment through three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the initiation of treatment through three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I - Dose limiting toxicities using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Phase II - Objective Response Rate (ORR)
Secondary outcome measures
Overall survival (OS)
Progression-free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Seleno-L Methionine (SLM) in Combination with Axitinib and PembrolizumabExperimental Treatment3 Interventions
SLM only will be taken by mouth during a two-week run in period. Then patients will receive SLM and Axitinib drugs by mouth, and Pembrolizumab intravenously (IV), at the start of each 21 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
2020
Completed Phase 2
~3050
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Yousef ZakhariaLead Sponsor
4 Previous Clinical Trials
140 Total Patients Enrolled
University of IowaOTHER
446 Previous Clinical Trials
879,447 Total Patients Enrolled
Yousef Zakharia, MDPrincipal InvestigatorUniversity of Iowa
4 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eligibility is not affected by my sex, race, or ethnicity.I agree to use effective birth control during and 6 months after the study.I haven't had a heart attack, severe chest pain, heart failure, or stroke in the last 6 months.I am not using, nor will I need, strong medication that affects liver enzymes.My liver tests are within the required limits, even with liver metastases.I can do my usual activities or light work but not heavy physical tasks.My kidney function, measured by creatinine levels, is within the normal range.You have HIV and your CD4+ T-cell count is less than 350 cells/uL.My kidney cancer is advanced and cannot be surgically removed, and I haven't received treatment for its advanced stage.I am older than 18 years.I have not had major surgery in the last 4 weeks.I don't have another cancer that could affect this treatment's safety or results.I have untreated brain or spinal cord metastases.I have HIV and have had serious infections because of it.I have a tumor that can be measured and hasn't been treated with radiation.Your blood tests show that you have enough white blood cells, platelets, and hemoglobin.My blood pressure is ≤150/90 mm Hg and stable on my current medication.
Research Study Groups:
This trial has the following groups:- Group 1: Seleno-L Methionine (SLM) in Combination with Axitinib and Pembrolizumab
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.
Are there opportunities for participants to enter this research endeavor?
"Affirmative, the information published on clinicaltrials.gov states that this trial is actively enrolling individuals. It was initially posted on September 19th 2022 and has been recently updated in a similar manner. The study needs 55 people to be recruited from one site."
Answered by AI
What is the uppermost limit of participants in this investigation?
"Affirmative. Information published on clinicaltrials.gov confirms that this medical experiment, which was initially posted on September 19th 2022 is presently recruiting participants. Approximately 55 volunteers need to be enlisted from 1 different health care facility."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger