Tyrosine Kinase Inhibitor

Cabozantinib + Nivolumab +/- Ipilimumab for Genitourinary Cancers

Los Angeles, CA

Phase 1

Waitlist Available

Led By Andrea B Apolo

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients in the phase I portion must have histologically confirmed diagnosis of metastatic, genitourinary solid tumor with at least one evaluable site of disease or appearance of one new bone lesion

Patients in the expansion portion must have histologically confirmed diagnosis of specific types of metastatic genitourinary cancers and progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging

Must not have

Patients with certain medical history or conditions including active brain metastases, significant cardiovascular disorders, gastrointestinal disorders, and other clinically significant disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best doses of cabozantinib s-malate and nivolumab with or without ipilimumab to treat patients with genitourinary tumors.

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Who is the study for?

Adults with advanced genitourinary cancers, who are in good physical condition (Karnofsky performance status >= 70%), and have not recently received certain treatments. Women must test negative for pregnancy and agree to contraception. Participants need available tissue for PD-L1 testing and understand the study's consent.Check my eligibility

What is being tested?

The trial is examining the effectiveness of Cabozantinib S-malate combined with Nivolumab, an immunotherapy drug, with or without another immunotherapy called Ipilimumab in patients whose cancer has spread beyond its original location.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, digestive issues, skin problems, hormonal gland issues like thyroid dysfunction, and possible infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed metastatic genitourinary cancer with at least one measurable tumor or a new bone lesion.

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I have a confirmed diagnosis of a specific type of metastatic genitourinary cancer with new or worsening lesions.

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I am 18 years old or older.

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My cancer tissue is available for PD-L1 testing.

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I am able to care for myself but may not be able to do active work.

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My recent lab tests show my organs are functioning well.

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Exclusion Criteria

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

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I do not have active brain tumors, serious heart, stomach, or other major health issues.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events (Phase I)

Recommended phase II dose (Phase I)

Secondary study objectives

Clinical response rate

Fraction of patients who have been identified as being alive and progression free at two months

PDL-1 and MET expression

Other study objectives

Overall response rate in patients receiving ipilimumab challenge/re-challenge

Progression free survival in bone-only urothelial carcinoma

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: Part II (cabozantinib s-malate, nivolumab, ipilimumab)Experimental Treatment8 Interventions

See detailed description.

Group II: Part I (cabozantinib s-malate, nivolumab)Experimental Treatment7 Interventions

Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 21 cycles, patients receive nivolumab IV over 30 minutes every 4 weeks in the absence of disease progression or unacceptable toxicity. After progression, patients may receive cabozantinib s-malate PO, nivolumab IV, and ipilimumab IV at the part II RP2D for 4 cycles followed by cabozantinib s-malate PO QD and nivolumab IV every 2 weeks or 4 weeks if post-cycle 21 in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography or magnetic resonance imaging and collection of blood samples throughout the trial. Patients may also undergo echocardiography at baseline and biopsies throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2020

Completed Phase 3

~1180

Biopsy

2014

Completed Phase 4

~1210