Clinical trial · Interventional
SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
Cytoreductive Stereotactic Hypofractionated Radiotherapy With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer
NCT04090710CI-TRIAL-00124575CYTOSHRINKcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab/ Nivolumab | Drug | Ipilimumab/Nivolumab Regimen | ALIAS |
| SBRT + Ipilimumab/Nivolumab | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care I/N alone
- description
- 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.
- interventionNames
- Drug: Ipilimumab/ Nivolumab
- type
- EXPERIMENTAL
- label
- Standard of Care I/N plus primary disease SBRT
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.