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Tyrosine Kinase Inhibitor

Cabozantinib + Nivolumab +/- Ipilimumab for Genitourinary Cancers

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.

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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (Phase I)
Recommended phase II dose (Phase I)
Secondary outcome measures
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 outcome measures
Overall response rate in patients receiving ipilimumab challenge/re-challenge
Progression free survival in bone-only urothelial carcinoma

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
Echocardiography
2013
Completed Phase 4
~11670
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1920
Cabozantinib S-malate
2013
Completed Phase 2
~470
Computed Tomography
2017
Completed Phase 2
~2790
Ipilimumab
2014
Completed Phase 3
~2640
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,494 Total Patients Enrolled
21 Trials studying Urethral Cancer
2,171 Patients Enrolled for Urethral Cancer
Andrea B ApoloPrincipal InvestigatorNational Cancer Institute LAO
3 Previous Clinical Trials
1,113 Total Patients Enrolled

Media Library

Cabozantinib S-malate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02496208 — Phase 1
Urethral Cancer Research Study Groups: Part II (cabozantinib s-malate, nivolumab, ipilimumab), Part I (cabozantinib s-malate, nivolumab)
Urethral Cancer Clinical Trial 2023: Cabozantinib S-malate Highlights & Side Effects. Trial Name: NCT02496208 — Phase 1
Cabozantinib S-malate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02496208 — 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 total capacity of participants in this clinical trial?

"This research is not currently enrolling patients. According to the data posted on 7/9/2015 and updated 10/1/2022, this trial has concluded participant recruitment. Although, there are 5,621 trials actively recruiting participants with metastatic sarcomatoid renal cell carcinoma and 840 studies for Ipilimumab seeking volunteers."

Answered by AI

How many health-care settings are conducting this research?

"This clinical trial is currently enrolling patients at 8 different sites, such as the Ohio State University Comprehensive Cancer Center in Columbus, City of Hope Comprehensive Cancer Centre in Duarte and Los Angeles County-USC Medical Centre in LA. Additionally there are 5 further locations where participants may be recruited."

Answered by AI

Has Ipilimumab earned clearance from the FDA?

"Due to the limited evidence of safety and efficacy, Ipilimumab was assigned a score of 1."

Answered by AI

Has there been any other research conducted on Ipilimumab's efficacy?

"Presently, 94 Phase 3 studies for Ipilimumab are underway with a total of 840 trials being conducted globally. Of those, several are located near Pittsburgh in Pennsylvania and the remaining 46020 locations span across the entire world."

Answered by AI

Are there still opportunities to join this clinical research initiative?

"This medical research is no longer recruiting individuals. It was first posted on July 9th 2015 and last amended October 1st 2022. Patients with metastatic sarcomatoid renal cell carcinoma should look into the 5621 clinical trials that are actively seeking participants, while those looking for Ipilimumab treatment can explore 840 studies currently enrolling patients."

Answered by AI

What maladies has Ipilimumab been used to address?

"Ipilimumab may be used to combat the development of unresectable melanoma, squamous cell carcinoma, and to prevent a relapse in high-risk patients."

Answered by AI
~8 spots leftby Sep 2024