Status:
ACTIVE_NOT_RECRUITING
SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 m...
Detailed Description
This is a multi-centre, open label, phase II randomized clinical trial evaluating SBRT as upfront cytoreductive therapy to the primary renal mass along with combination I/N therapy in patients with in...
Eligibility Criteria
Inclusion
- Biopsy proven renal cell carcinoma of any histology.
- Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.
- Intermediate/poor risk disease based on IMDC criteria (see Appendix II).
- Primary kidney lesion amenable to SBRT.
- Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph.
Exclusion
- A maximum primary renal lesion size of 20 cm or greater.
- Candidate for cytoreductive nephrectomy, unless a patient has refused cytoreductive nephrectomy (in this case, a discussion of cytoreductive nephrectomy and patient refusal must be documented).
- Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma.
- Previous abdominal radiation precluding SBRT.
- Kanofsky Performance (KPS) score below 60 (see Appendix III).
- History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.
- History of ataxia telangiectasia or other radiation sensitivity disorders.
- Chronic corticosteroid use or other chronic immune suppressive therapy. (Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses of prednisone ≤ 10 mg daily are permitted).
- Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician.
- Inability to lie flat for at least 30 minutes without moving.
- Pregnant or lactating women.
- Geographic inaccessibility for follow-up.
- Inability to provide informed consent.
Key Trial Info
Start Date :
January 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04090710
Start Date
January 29 2020
End Date
April 30 2026
Last Update
August 3 2025
Active Locations (7)
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1
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
3
Juravinski Cancer Centre
Hamilton, Ontario, Canada
4
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G1G3