SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

January 29, 2020

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Metastatic Renal Cell Carcinoma
Interventions
DRUG

Ipilimumab/ Nivolumab

induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for cycles 1-4 followed by maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression

RADIATION

SBRT + Ipilimumab/Nivolumab

SBRT to the primary disease in-situ, prior to cycle 2-4 of I/N. Patients randomized to SBRT will undergo radiation planning during the first cycle of I/N to their primary kidney mass, and then the radiation will be delivered between cycles 1 and 2 to a dose of 30-40 Gy in 5 fractions every other day over 1.5 weeks.

Trial Locations (7)

3000

Peter MacCallum Cancer Centre, Melbourne

T6G 1Z2

Cross Cancer Institute, Edmonton

Unknown

Juravinski Cancer Centre, Hamilton

N2G1G3

Grand River Regional Cancer Centre, Kitchener

London Regional Cancer Centre, London

K1H8L6

The Ottawa Regional Cancer Centre, Ottawa

M4N3M5

Sunnybrook Health Sciences Centre- Odette Cancer Centre, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Ontario Clinical Oncology Group (OCOG)

OTHER