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RecruitingLast updated: 5 February 2024

CYTOSHRINK: This phase II trial is assessing the effect of adding radiotherapy (stereotactic body radiation therapy - SBRT) to the standard of care treatment immunotherapy (ipilimumab/nivolumab), compared with immunotherapy as a standard alone treatment, in people with metastatic kidney cancerCytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

Clinical summary

Summary

This is a randomised trial with active comparator and experimental arms. Participants in the Active Comparator arm will receive the standard of care treatment of ipilimumab/nivolumab alone. 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 (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Participants in the Experimental Arm will receive the standard of care treatment if I/N plus primary disease SBRT. Induction ipilimumab 1 mg/kg combined with nivolumab 3 mg/kg (I/N) every 3 weeks for one cycle, followed by 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. Approximately one week following completion of SBRT, patients will start cycle 2 of immunotherapy as per standard of care. The total time elapsed between the start of cycle 1 and 2 of I/N should be no more than 6 weeks. After completion of up to four cycles of I/N, patients will proceed to standard of care maintenance treatment with nivolumab 240mg every 2 weeks or 480mg every 4 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment.

Conditions

This trial is treating patients with metastatic renal cell cancer

Cancer

Urinary System Cancers Genitourinary

Phase

II

Trial Acronym

CYTOSHRINK

More information

Trial Identifiers

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Trial sponsor

Ontario Clinical Oncolgy Group (OCOG)

Scientific Title

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

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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