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Checkpoint Inhibitor

Immunotherapy for Kidney Cancer

Phase < 1
Waitlist Available
Led By Padmanee Sharma
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 can have had prior treatment for RCC including prior surgery, radiation therapy, immunotherapy with interleukin (IL)-2 or interferon (but not anti-programmed cell death [PD]1 or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]), target therapy with receptor tyrosine kinase (RTK) inhibitors/mammalian target of rapamycin (mTOR) inhibitors, such as sunitinib, sorafenib, pazopanib, axitinib, everolimus, and temsirolimus (but not bevacizumab) or chemotherapy
Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy, metastasectomy or post-treatment biopsy; diagnosis must be confirmed by pathologist review of screening biopsy; the determination of resectability will ultimately lie in the clinical judgment of the urologist and medical oncologist involved in the care of the patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial tests immunotherapy to treat kidney cancer that has spread. Monoclonal antibodies may help the body attack cancer cells & slow their growth.

Who is the study for?
This trial is for adults with metastatic clear cell renal cell carcinoma (kidney cancer) that can be surgically removed. Participants must understand the study and risks, may have had previous treatments except certain immunotherapies or bevacizumab, and should meet specific health criteria like adequate blood counts and organ function.Check my eligibility
What is being tested?
The trial tests how well nivolumab works alone or combined with bevacizumab or ipilimumab before surgery in patients with kidney cancer. It's an early phase I pilot study to see if these monoclonal antibodies can boost the immune system to fight cancer and prevent tumor growth.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, possible bleeding from bevacizumab use, liver enzyme changes, skin rash, diarrhea from ipilimumab use, and other typical chemotherapy-associated risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had treatments for kidney cancer but not with PD1 or CTLA-4 inhibitors or bevacizumab.
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My kidney cancer has spread, and I am eligible for surgery to remove the tumor.
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I have a tumor or lymph node that can be measured and meets the size requirements.
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My hemoglobin level is above 9.0 g/dL, possibly with help from treatments.
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My kidney function, measured by creatinine levels, is within the normal range.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Duration of response
Immunological changes in tumor tissues and peripheral blood
Objective response rates
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (nivolumab, ipilimumab, surgery)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1 every 3 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (nivolumab, bevacizumab, surgery)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 60 minutes and bevacizumab IV over 90 minutes on day 1 every 2 weeks for 6 weeks. Patients also undergo nephrectomy, metastasectomy or biopsy as in Arm A. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (nivolumab, surgery)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 60 minutes on day 1 every 2 weeks for 6 weeks. Approximately 4 weeks later, patients undergo nephrectomy, metastasectomy or biopsy. Beginning 4-6 weeks after surgery, patients in all arms who have clinical response, stable disease, or even slight progression of disease to therapy preoperatively, receive maintenance nivolumab IV over 60 minutes on day 1. Cycles repeat every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Ipilimumab
FDA approved
Bevacizumab
FDA approved
Metastasectomy
2010
N/A
~100
Nivolumab
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,345 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,542 Total Patients Enrolled
Padmanee SharmaPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
29 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment presently available for this clinical study?

"From the information accessible on clinicaltrials.gov, it is evident that this particular trial does not currently need any subjects as its last update was made in March 2020. Nevertheless, there are 2781 other studies presently recruiting participants to join their research teams."

Answered by AI
~16 spots leftby Nov 2025