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Tyrosine Kinase Inhibitor

Sequential Therapy for Kidney Cancer

Q: What is the participation rate for this clinical investigation?

Indeed, clinicaltrials.gov affirms that this experiment is presently recruiting participants. It was first published on February 24th 2023 and has been revised as recently as May 12th of the same year. The research team seeks to admit twenty people at a single testing centre.

Q: Which individuals are best suited for this research program?

To become part of this medical trial, applicants must have been diagnosed with <a href="https://www.withpower.com/clinical-trials/kidney-cancer">kidney cancer</a> and be aged between 18-99. At the moment, our team is looking to recruit 20 patients for this study.

Q: Is eligibility for this medical study restricted to those under 35 years old?

Eligible participants for this research must be between 18 to 99 years of age.

Q: Are recruitment efforts for this research ongoing?

According to the details shared on clinicaltrials.gov, this study is actively recruiting participants. It was initially posted in February of 2023 and its most recent update took place in May 12th of that same year.

Q: Are there any other scientific studies involving individuals with metastatic or inoperable clear cell renal cell carcinoma?

At present, 973 clinical trials are in progress that investigate treatments for metastatic or unresectable clear cell <a href="https://www.withpower.com/clinical-trials/renal-cell-carcinoma">renal cell carcinoma</a>. Of these experiments, 122 have progressed to the third phase. Primarily located in Pittsburgh, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> there exists a total of 53455 medical sites conducting research on this illness.

Q: What conventional treatments are used to manage metastatic or unresectable clear cell renal cell carcinoma in patients?

Clear cell renal carcinoma which is metastatic or non-operable can be cured using <a href="https://www.withpower.com/clinical-trials/lenalidomide">lenalidomide</a>. Additionally, this treatment may also help patients suffering from <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, <a href="https://www.withpower.com/clinical-trials/lung-cancer">lung cancer</a> and advanced carcinoid tumor.

Phase < 1

Recruiting

Led By Che-Kai Tsao

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years at the time of study entry

Patients with localized RCC who develop metastatic disease post definitive nephrectomy, with or without systemic therapy in the adjuvant setting, are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Study Summary

This trial tests a new sequence of treatments for clear cell renal cell carcinoma, to see how effective they are.

Who is the study for?

Adults with advanced or metastatic clear cell renal cell carcinoma that can't be surgically removed. They should have a life expectancy of at least 12 weeks, measurable disease, and good organ function. Participants must not be pregnant, have had certain cancers within the last 3 years, or received specific treatments for kidney cancer before.Check my eligibility

What is being tested?

The study tests a sequence of drugs: Cabozantinib for 12 weeks followed by Ipilimumab plus Nivolumab immunotherapy over another 12 weeks. Depending on response, treatment may continue with either Nivolumab alone or in combination with Lenvatinib/Everolimus.See study design

What are the potential side effects?

Potential side effects include diarrhea, high blood pressure from Cabozantinib; colitis, skin rash from Ipilimumab; fatigue, skin conditions from Nivolumab; and mouth sores, weakness from Lenvatinib/Everolimus. Side effects vary based on individual reactions to the medications.

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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I had kidney cancer, underwent kidney removal, and now it has spread.

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My kidney cancer cannot be cured with surgery or radiation and is mostly clear cell type.

Select...

I am fully active or able to carry out light work.

Select...

I can provide a tumor sample with a pathology report for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Overall Response Rate (ORR)

Secondary outcome measures

Diagnostic Odds Ratio (DoR)

Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19)

Overall Survival (OS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with metastatic or unresectable clear cell renal cell carcinomaExperimental Treatment5 Interventions

Patients with metastatic or unresectable clear cell renal cell carcinoma to receive same sequential treatment strategy. (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks [Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG]).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabozantinib

2020

Completed Phase 2

~1080

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

Lenvatinib

2005

Completed Phase 4

~2690

Everolimus

2010

Completed Phase 4

~1510

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

524,456 Total Patients Enrolled

Che-Kai TsaoPrincipal InvestigatorInvestigator

Media Library

Kidney Cancer Research Study Groups: Patients with metastatic or unresectable clear cell renal cell carcinoma

Kidney Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05188118 — Phase < 1

Frequently Asked Questions

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

What is the participation rate for this clinical investigation?

"Indeed, clinicaltrials.gov affirms that this experiment is presently recruiting participants. It was first published on February 24th 2023 and has been revised as recently as May 12th of the same year. The research team seeks to admit twenty people at a single testing centre."

Answered by AI

Which individuals are best suited for this research program?

"To become part of this medical trial, applicants must have been diagnosed with kidney cancer and be aged between 18-99. At the moment, our team is looking to recruit 20 patients for this study."

Answered by AI

Is eligibility for this medical study restricted to those under 35 years old?

"Eligible participants for this research must be between 18 to 99 years of age."

Answered by AI

Are recruitment efforts for this research ongoing?

"According to the details shared on clinicaltrials.gov, this study is actively recruiting participants. It was initially posted in February of 2023 and its most recent update took place in May 12th of that same year."

Answered by AI

Are there any other scientific studies involving individuals with metastatic or inoperable clear cell renal cell carcinoma?

"At present, 973 clinical trials are in progress that investigate treatments for metastatic or unresectable clear cell renal cell carcinoma. Of these experiments, 122 have progressed to the third phase. Primarily located in Pittsburgh, Pennsylvania there exists a total of 53455 medical sites conducting research on this illness."

Answered by AI

What conventional treatments are used to manage metastatic or unresectable clear cell renal cell carcinoma in patients?

"Clear cell renal carcinoma which is metastatic or non-operable can be cured using lenalidomide. Additionally, this treatment may also help patients suffering from squamous cell carcinoma, lung cancer and advanced carcinoid tumor."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

Che-Kai Tsao 2023. "Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05188118.

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