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Monoclonal Antibodies
Axitinib + Anti-OX40 Antibody for Kidney Cancer
Phase 2
Waitlist Available
Led By Sarmad Sadeghi
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Zubrod performance status of =< 2
Metastatic RCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 180 days
Awards & highlights
Study Summary
This trial is studying axitinib with or without anti-OX40 antibody to treat patients with kidney cancer.
Who is the study for?
This trial is for adults with metastatic kidney cancer who've had a nephrectomy, have measurable disease, and proper organ function. They must not be pregnant or breastfeeding, use effective contraception, and can't have brain metastases requiring steroids, active autoimmune diseases, recent major surgeries or certain medical conditions.Check my eligibility
What is being tested?
The study tests axitinib alone versus in combination with anti-OX40 antibody PF-04518600 to see which is better at treating metastatic kidney cancer. Axitinib blocks enzymes needed for tumor growth; the antibody may stimulate the immune system to fight cancer cells.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that could affect various organs, high blood pressure due to axitinib's effect on blood vessels, fatigue from both treatments affecting energy levels, and possible digestive issues like diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My kidney cancer has spread to other parts of my body.
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I am a man using highly effective birth control.
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My kidney cancer is mostly made up of clear cells.
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I have had a kidney removal surgery and can provide the tissue sample.
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My kidney function is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 180 days
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 (PFS)
Secondary outcome measures
Incidence of unacceptable toxicity
ORR defined as either complete response or partial response occurring any time during treatment and assessed by RECIST 1.1 and immune-related RECIST (irRECIST) criteria
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (axitinib, anti-OX40 antibody PF-04518600)Experimental Treatment3 Interventions
Patients receive axitinib PO BID on days 1-14 and anti-OX40 antibody PF-04518600 IV over 60 minutes on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (axitinib, placebo)Active Control3 Interventions
Patients receive axitinib as in Arm I and placebo IV on day 1 beginning with course 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axitinib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,427 Total Patients Enrolled
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,216 Total Patients Enrolled
Sarmad SadeghiPrincipal InvestigatorUniversity of Southern California
2 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking certain medications.You have a history of or currently have autoimmune disorders.I haven't had any cancer except for treatable ones in the last 3 years.I have had a severe reaction to immune therapy.Criterion: You have a measurable disease according to specific guidelines for evaluating tumors.I can take care of myself but might not be able to do heavy physical work.I do not have any severe medical, psychiatric conditions, or recent suicidal thoughts.I haven't taken steroids or immunosuppressants in the last 14 days.I have a health condition that could make this study risky for me.I agree to a biopsy from a metastatic site within 12 weeks before joining.I do not have any active infections, including HBV, HCV, HIV, or AIDS.I have had adriamycin treatment and may be at risk for heart failure.I have a condition or had surgery that affects how my body absorbs medication.Your level of aspartate aminotransferase (AST) should be no more than 3 times the upper limit of normal.I have side effects from previous treatments that are not just hair loss and are still serious.You have had a serious allergic reaction to any monoclonal antibody in the past.People who are in prison or being held against their will.Your white blood cell count is at least 2000 per microliter.Your platelet count should be at least 100,000 per microliter of blood.I haven't had major surgery in the last 6 weeks or minor surgery in the last 4 weeks.I haven't had cancer treatment or radiation in the weeks before starting the study drug.My kidney cancer has spread to other parts of my body.I have had a severe allergic reaction to certain protein treatments or antibodies.I have a history of heart, brain, or lung conditions.I am not pregnant or breastfeeding.My condition worsened within 6 months after my last treatment.I have an ongoing liver disease.Your neutrophil count is at least 1500 per microliter.I am taking steroids for brain metastases symptoms.Your bilirubin level is within a certain range.My adrenal gland disorder is not under control.I am a man using highly effective birth control.Your liver enzyme levels (ALT) should not be more than 3 times the normal limit.I have been treated with an mTOR inhibitor or axitinib before.My kidney cancer is mostly made up of clear cells.Your hemoglobin level must be 9 grams per deciliter or higher.I have had a kidney removal surgery and can provide the tissue sample.My kidney function is within the normal range.I have been treated with specific antibodies or drugs before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (axitinib, placebo)
- Group 2: Arm I (axitinib, anti-OX40 antibody PF-04518600)
Awards:
This trial has 1 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Is this clinical trial taking place at more than one location in the city?
"Currently, this study has 10 patients enrolled. The locations of the enrollees include USC / Norris Comprehensive Cancer Center in Los Angeles, University of Kansas Cancer Center in Kansas City, and Los Angeles County-USC Medical Center in Cleveland. There are also 10 other locations with enrollees for this study."
Answered by AI
Are people with the specific medical condition being recruited for this study at this time?
"No, this specific trial is not currently seeking patients. However, according to the information on clinicaltrials.gov, which was last updated on August 5th, 2022, there are 2720 other trials that are still looking for participants."
Answered by AI
What makes this experiment novel in comparison to others like it?
"Axitinib has undergone clinical trials since 2011, when it was first studied by Pfizer. After the initial 39-person Phase 1 trial in 2011, Axitinib received approval for Phase 2 testing. As of now, there are 55 active studies involving Axitinib taking place in 398 cities and 30 countries."
Answered by AI
How many individuals are being given this medication as part of the research study?
"As of 8/5/2022, this clinical trial is no longer recruiting patients. The study was originally posted on 7/19/2017. If you are looking for other studies, there are 2665 active trials related to carcinoma, renal cell and 55 Axitinib studies currently admitting patients."
Answered by AI
What have been the most common adverse effects of Axitinib in patients?
"Axitinib's safety is based on preclinical data and Phase 2 trial results, so it received a score of 2."
Answered by AI
Are there other examples in the medical literature of Axitinib's efficacy?
"Axitinib was first trialled in 2011 at University of Texas MD Anderson Cancer Center. So far, there have been a total of 18903 completed trials. Right now, 55 clinical trials are active with several of them based in Los Angeles, California."
Answered by AI
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