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Tyrosine Kinase Inhibitor

Sequential Therapy for Kidney Cancer

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.
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I am fully active or able to carry out light work.
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I can provide a tumor sample with a pathology report for testing.

Timeline

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
~1760
Ipilimumab
2014
Completed Phase 3
~2610
Nivolumab
2014
Completed Phase 3
~4750
Lenvatinib
2005
Completed Phase 4
~2690
Everolimus
2010
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,231 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
~10 spots leftby Dec 2025
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