Study Details

Open

Phase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors

This study is being done to test the good and bad effects of the drugs called cabozantinib, nivolumab and ipilimumab, when given in combination. This combination of drugs may or may not shrink your cancer, but it could also cause side effects, which are described in the risks section below. The study doctors hope to learn if the study drugs will stabilize or shrink your cancer. All these drugs, cabozantinib, nivolumab and ipilimumab have already been approved by the FDA to treat other cancers individually but not in combination.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Orange)

What will be asked of you

The study involves physical exams, EKGs, vital signs, blood draws for labs and research, urinalysis, a variety of imaging procedures that include CT or MRI and bone scans, submission of biopsy tissue, paper questionnaires, adverse event assessments, and study drug treatment. For a certain number of patients, dental exams or echocardiograms may be required.

Incentives

Study medication

Total length of participation:
2yrs

Looking for Specific Volunteers

Able to participate:

Patient is willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information.
Patient has disease that has spread (metastatic), defined as new or progressive lesions on imaging scan.
Patient has measurable disease.
Patient has a confirmed diagnosis of one of the following metastatic cohorts (small cell/neuroendocrine carcinoma of bladder, adenocarcinoma of bladder, squamous cell carcinoma of bladder.
Patient may have received up to two anti-cancer treatments.

Not eligible if:

Patient received chemotherapy or other biologic agents within two weeks of first dose of study drug.
Patient has active autoimmune disease that requires continued therapy.
Patient has another active malignancy within two years of registration.
Patient has active hepatitis B/C.
Patient has active brain metastases (cancer spread to brain) although there are some exceptions.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Tracy Rose
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Bladder, Kidney)
Urinary and Bladder

IRB Number

19-1570

ClinicalTrials.gov

NCT03866382