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Maintenance Therapy After Radiation for Renal Cell Carcinoma
Phase 2
Recruiting
Led By Chad Tang, MD
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
Be ≥18 years of age on the day of signing informed consent.
Pathologically confirmed diagnosis of RCC with a clear cell component.
Must not have
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Immunocompromising conditions, including known acute or chronic human immunodeficiency virus (HIV) infection, history of primary immunodeficiency, and history of allogeneic tissue/solid organ transplant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if more therapy can help keep RCC under control after radiation.
Who is the study for?
This trial is for adults over 18 with a specific kidney cancer (RCC) that has spread to no more than five places. They must have good organ function, not be on immunosuppressants or have had severe reactions to immune checkpoint inhibitors before, and can't be pregnant.
What is being tested?
The study tests if pembrolizumab, an immune therapy drug, helps control RCC when given for a year after radiation therapy. Patients are randomly chosen to receive either the drug plus radiation or radiation alone.
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects affecting organs like lungs or intestines, skin rashes, hormone gland problems (like thyroid), fatigue, and infusion reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney cancer diagnosis includes clear cell type.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not received a live vaccine within the last 30 days.
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I do not have conditions that weaken my immune system, such as HIV or a history of organ transplant.
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I had severe side effects from immune therapy, except for manageable hormone issues.
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My cancer has spread widely and cannot be fully treated, according to my doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Radiation therapy (Control Arm)Experimental Treatment2 Interventions
Participants will be asked to receive radiation therapy and be randomly assigned to receive pembrolizumab or not after that.
Group II: Radiation Therapy and PembrolizumabExperimental Treatment2 Interventions
Participants will be asked to receive radiation therapy and be randomly assigned to receive pembrolizumab or not after that.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850
Pembrolizumab
2017
Completed Phase 3
~3130
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,183 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,031 Previous Clinical Trials
5,189,558 Total Patients Enrolled
Cancer Prevention Research Institute of TexasOTHER
54 Previous Clinical Trials
98,890 Total Patients Enrolled
Chad Tang, MDPrincipal InvestigatorM.D. Anderson Cancer Center