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Checkpoint Inhibitor
Nivolumab + Ipilimumab for Kidney Cancer
Phase 2
Waitlist Available
Led By Nizar M Tannir
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with locally advanced or metastatic RMC histologically confirmed by expert pathology review and loss of SMARCB1 staining by immunohistochemistry
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is studying nivolumab and ipilimumab to see how well they work in treating patients with kidney cancer.
Who is the study for?
This trial is for patients with kidney cancer, specifically Renal Medullary Carcinoma. Participants can be new to treatment or have had previous therapies, must not be HIV positive or pregnant, and should not have other severe medical conditions. They need a good performance status (able to carry out daily activities) and acceptable blood test results.Check my eligibility
What is being tested?
The trial is testing the combination of two immunotherapy drugs: Nivolumab and Ipilimumab. These drugs are designed to help the immune system recognize and fight cancer cells in patients with advanced kidney cancer.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs like the liver, intestines, skin, hormone glands; fatigue; infusion reactions; possible worsening of pre-existing autoimmune diseases; and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread, and tests show a specific protein is missing.
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I can take care of myself and am up and about more than half of the day.
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I am willing to provide a fresh biopsy of my tumor.
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My kidney function, measured by creatinine, is within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) defined as completion response or partial response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Progression-free survival (PFS) assessed by RECIST criteria
Secondary outcome measures
Incidence of adverse events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab)Experimental Treatment2 Interventions
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,307 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,511 Total Patients Enrolled
Nizar M TannirPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery or significant injury in the last 4 weeks.I have received an organ transplant from another person.Your blood clotting tests should not be more than 1.5 times higher than the normal range before joining the study.I don't have any health conditions that would make the study drug unsafe for me.I haven't had any cancer except for specific skin cancers or treated cervical cancer in the last 2 years.You have tested positive for hepatitis B or C, indicating an ongoing infection.I am taking high dose steroids or strong immune-suppressing drugs.Your blood must have enough white blood cells called neutrophils.Your platelet count is at least 75,000 per microliter of blood.Your AST or ALT levels in your blood are not more than 2.5 times the normal limit.I am not currently on cancer treatment and haven't been for the last 2 weeks.I understand the study's risks despite my psychiatric history.My kidney cancer is advanced or has spread and shows medullary features.I agree to use contraception for 5 months after my treatment ends.Your total bilirubin level should be less than or equal to 1.5 mg/dl.My cancer is advanced or has spread, and tests show a specific protein is missing.It doesn't matter if my kidney tumor has been removed or is still there.I can take care of myself and am up and about more than half of the day.I have not received any live vaccines within a week before joining the study or during it.I am not on any other treatments for kidney cancer.I am willing to provide a fresh biopsy of my tumor.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I have at least one tumor that can be measured.My cancer has spread to my brain or its coverings and is not under control.Your condition must have gotten worse after your last treatment.I may or may not have had previous treatments for my condition.My brain cancer was treated with surgery or targeted radiation and has been stable for at least a month.My kidney function, measured by creatinine, is within normal limits.Your hemoglobin level is at least 9 grams per deciliter.Women who could become pregnant must have a negative pregnancy test within 24 hours before starting the study drug.I have an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, ipilimumab)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
How many people are included in this clinical trial's research pool?
"This study is not recruiting at the moment. The last update to this trial was on September 22nd, 2022 and it was originally posted December 13th, 2017. If you're looking for other studies, there are currently 2842 trials actively recruiting patients with carcinoma and neuroendocrine cancers and 796 studies using Nivolumab seeking participants."
Answered by AI
What other data is available on Nivolumab's efficacy?
"There are presently 796 active studies exploring nivolumab with 86 of them in Phase 3 testing. The majority of these clinical trials are based in Pittsburgh, Pennsylvania; however, there are 43,300 sites worldwide conducting research on nivolumab."
Answered by AI
Has Nivolumab been given the green light by the FDA?
"Nivolumab's safety is currently unproven, as this drug is still in Phase 2 of clinical trials. There is some data supporting its safety, but none yet to suggest that it is an effective medication."
Answered by AI
What are some of the diseases that Nivolumab has been known to improve?
"Nivolumab is frequently used as a treatment for patients who have undergone anti-angiogenic therapy. Additionally, this medication can be prescribed to treat other illnesses such as malignant neoplasms or squamous cell carcinoma."
Answered by AI
Are there any current vacancies for participants in this clinical trial?
"Unfortunately, this study has already completed recruitment for participants. However, there are presently 2842 trials actively admitting patients with carcinoma and neuroendocrine and 796 studies for Nivolumab that are still looking for volunteers."
Answered by AI
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