CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Mark Stein
Study ID
NCT04322955
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    2 x 20 mg capsules taken orally daily
  • Nivolumab — DRUG
    480mg IV on first day of each 28-day cycle
  • Cytoreductive nephrectomy — PROCEDURE
    Surgery removing as much tumor tissue as possible, possibly including surrounding tissues.

Study Details

The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney, will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment.

Key Dates

Start date
Jun 22, 2020
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with cabozantinib and nivolumab with nephrectomy
    All study participants will receive the same study medications, cabozantinib and nivolumab. The study drug, nivolumab, will be administered through an IV infusion every 4 weeks and cabozantinib will be administered orally daily. Initially participants will receive study treatment for 12 weeks. The cabozantinib will then be stopped prior to the nephrectomy. Initially patients enrolled on the study will be assigned to cohort 1. Patients who are assigned to cohort 1 will be treated with cabozantinib until 21 days prior to surgery. A patient in cohort 1 will be evaluable for assessment of the cabozantinib washout interval ("evaluable patients") if they 1. complete at least 10 of the 14 scheduled cabozantinib doses in the two week period prior to stopping cabozantinib AND 2. have surgical resection of the primary tumor. In cohort 2, subjects will receive cabozantinib until 14 days prior to nephrectomy.

Primary Outcome Measure

Percentage of Participants with a Complete Response [ Time Frame: Up to 5 years after completion of treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
The Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Columbia University Irving Medical CenterNew YorkNew York10032-
Cleveland ClinicClevelandOhio44012-
Ohio State University Wexner Medical CenterColumbusOhio43221-

Find similar trials in New Brunswick, NJ

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
The Rutgers Cancer Institute of New Jersey· New Brunswick, NJColumbia University Irving Medical Center· New York, NYCleveland Clinic· Cleveland, OHOhio State University Wexner Medical Center· Columbus, OH

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