SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Bristol-Myers Squibb
• Treatments: Ipilimumab; Nivolumab

Criteria

Inclusion Criteria:

1. Biopsy proven renal cell carcinoma of any histology.

2. Imaging proven metastatic disease based on CT or MRI within 10 weeks of screening.

3. Intermediate/poor risk disease based on IMDC criteria (see Appendix II).

4. Primary kidney lesion amenable to SBRT.

5. Eligible for standard of care delivery of ipilimumab and nivolumab (I/N) according to approved product monograph.

Exclusion Criteria:

1. A maximum primary renal lesion size of 20 cm or greater.

2. 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).

3. Treatment with prior systemic therapy in the adjuvant or metastatic setting for renal cell carcinoma.

4. Previous abdominal radiation precluding SBRT.

5. Kanofsky Performance (KPS) score below 60 (see Appendix III).

6. History of auto-immune disorder precluding treatment with ipilimumab or nivolumab.

7. History of ataxia telangiectasia or other radiation sensitivity disorders.

8. 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).

9. Use of medicinal herbal preparations (not including medical cannabis) unless prescribed by a treating physician.

10. Inability to lie flat for at least 30 minutes without moving.

11. Pregnant or lactating women.

12. Geographic inaccessibility for follow-up.

13. Inability to provide informed consent.