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ACTIVE NOT RECRUITING
NCT04090710
PHASE2

SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

Sponsor: Ontario Clinical Oncology Group (OCOG)

View on ClinicalTrials.gov

Summary

This trial will evaluate the addition of cytoreductive stereotactic body radiation therapy (SBRT) to standard of care combination ipilimumab and nivolumab (I/N) versus I/N alone for the treatment of metastatic kidney cancer.

Official title: Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2020-01-29

Completion Date

2026-04-30

Last Updated

2025-08-03

Healthy Volunteers

No

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.

Locations (7)

Peter MacCallum Cancer Centre

Melbourne, Australia

Cross Cancer Institute

Edmonton, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Grand River Regional Cancer Centre

Kitchener, Ontario, Canada

London Regional Cancer Centre

London, Ontario, Canada

The Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre- Odette Cancer Centre

Toronto, Ontario, Canada