SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidney Cancer Patients
NCT03065179 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2021-03-30
Summary
This is a multi-institution, single-arm phase II study to determine the safety and efficacy of SBRT (up to 2 metastatic sites preferentially lung, mediastinum or bone in combination of nivolumab and ipilimumab in patients with metastatic renal cell carcinoma(with a clear-cell component and at least 1 measurable metastatic lesion that is not being irradiated).
Conditions
- Kidney Cancer Metastatic
- Kidney Cancer
- Kidney Cancer, Stage IV
Interventions
- DRUG
-
Nivolumab/Ipilimumab
IV immunotherapy
- RADIATION
-
SBRT
SBRT will be delivered in conjunction with immunotherapy
Sponsors & Collaborators
-
University of Texas Southwestern Medical Center
lead OTHER
Principal Investigators
-
Hans Hammers, MD, PhD · UT Southwestern Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-01
- Primary Completion
- 2020-02-20
- Completion
- 2020-11-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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