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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 2 years.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 2 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

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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

Pembrolizumab

2017

Completed Phase 2

~2010

Radiation therapy

2013

Completed Phase 3

~2850

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,330 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,002 Total Patients Enrolled

Cancer Prevention Research Institute of TexasOTHER

50 Previous Clinical Trials

98,294 Total Patients Enrolled

Frequently Asked Questions

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

What potential risks do patients face with Radiation therapy (Control Arm)?

"Despite the lack of data to support its efficacy, Radiation therapy (Control Arm) is thought to be reasonably safe with a rating of 2 on our internal scale."

Answered by AI

Is enrollment currently open for this examination?

"Clinicaltrials.gov reveals that this medical trial is not presently recruiting patients, having been initially posted on the 1st of January 2024 and most recently updated on August 21st 2023. Although no longer actively pursuing participants, there are still 2679 studies searching for volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)

2023. "A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004336.

All > Metastatic Renal Cell Carcinoma