SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidney Cancer Patients

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03065179
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab/Ipilimumab — DRUG
    IV immunotherapy
  • SBRT — RADIATION
    SBRT will be delivered in conjunction with immunotherapy

Study Details

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).

Key Dates

Start date
Mar 1, 2017
Status verified
Mar 2021
Primary completion
Feb 20, 2020
Completion
Nov 17, 2020

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab/Ipilimumab plus SBRT
    Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy

Primary Outcome Measure

Number of Participants With Treatment-related Adverse Events Grade 3 or Higher as Assessed by CTCAE v4.0 [ Time Frame: up to 35 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
UT SouthwesternDallasTexas75390-

Find similar trials in Baltimore, MD

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MDUT Southwestern· Dallas, TX

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