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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

Must not have

Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment; ongoing clinically relevant complications from prior radiation therapy are not eligible

Inability to swallow tablets

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had recent radiation or radionuclide treatments and have no ongoing complications from them.

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I cannot swallow pills.

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I have had an autoimmune disease in the last 2 years.

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I have had cancer spread to the lining of my brain and spinal cord.

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I am currently taking blood thinners.

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I do not have any other cancer that needs treatment.

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I received my last cancer treatment less than 4 weeks ago or within five half-lives of the treatment.

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I had a severe reaction to previous immunotherapy, or I still have moderate side effects from it.

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I have previously received treatments like cabozantinib or nivolumab for advanced kidney cancer.

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I have not received a live vaccine within the last 30 days and do not plan to during the study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Overall Response Rate (ORR)

Secondary study objectives

Diagnostic Odds Ratio (DoR)

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

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Everolimus

2010

Completed Phase 4

~1510

Nivolumab

2015

Completed Phase 3

~4010