Active — Not RecruitingPhase 1

Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors

United States152 participantsStarted 2015-07-22

Plain-language summary

This phase I trial studies the side effects and best doses of cabozantinib s-malate and nivolumab with or without ipilimumab in treating patients with genitourinary (genital and urinary organ) tumors that have spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving cabozantinib s-malate and nivolumab alone or with ipilimumab works better in treating patients with genitourinary tumors.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients in the phase I portion must have: * Histologically confirmed diagnosis of metastatic, genitourinary solid tumor * Metastatic disease defined as new or progressive lesions on cross-sectional imaging; patients must have 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 metastatic: * Urothelial carcinoma of the bladder, urethra, ureter, renal pelvis, OR * Clear cell renal cell carcinoma OR * Adenocarcinoma of the bladder OR * Non-resectable squamous cell carcinoma of the penis OR * Squamous or small cell carcinoma of the bladder, renal medullary carcinoma (RMC), sarcomatoid bladder and renal cell carcinomas, plasmacytoid carcinoma of the bladder or other rare bladder/kidney cancer histology AND * Patients with urothelial cancer or renal cell carcinoma must have progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging; patients must have at least: * One measurable site of disease (according to RECIST criteria) or bone disease by NaF PET/CT * Patients must have either progressed on at least one standard therapy or there must be no standard treatment that has been shown to prolong survival for the patient's disease (patients with urothelial carcinoma who are cisplatin-ineligible may receive protocol therapy as a first line therapy); patients may have …

What they're measuring

Recommended phase II dose (Phase I)

Timeframe: Up to 4-6 weeks

Incidence of adverse events (Phase I)

Timeframe: Up to 30 days post treatment

Trial details

NCT IDNCT02496208

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-09-30