At a glance
ClinicalIndex Comparison Record- ✓Histologically proven clear cell or non-clear cell renal cell carcinoma (excluding collecting duct)
- ✓Primary tumor must be in place
- ✓Clinical evidence of measurable or non-measurable metastatic disease on imaging
- ✓CT chest and CT/MRI abdomen-pelvis within 90 days prior to registration/first dose
- ✕Collecting duct carcinoma histology
- ✕Solitary kidney or transplanted kidney
- ✕Treatment-naive: any prior systemic therapy for metastatic RCC
- ✕Previously treated: >1 prior systemic therapy regimen for metastatic RCC
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
In Brief
A Phase 3 clinical trial evaluating Cytoreductive Nephrectomy and Active Comparator for Metastatic Clear Cell Renal Cell Carcinoma and 2 related conditions. Currently recruiting, targeting 364 participants across 387 sites.
Detailed Summary
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Study Details
Timeline
Interventions
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization
Nivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID