Table 2.
Key Inclusion Criteria | Key Exclusion Criteria |
•Clinical T2 or any node positive RCC | •No active or suspected autoimmune disorders |
•No evidence of metastatic disease (M0) | - Exceptions: vitiligo, diabetes type 1, hypothyroid on stable hormone |
•Clear cell or non-clear cell histology | replacement, psoriasis, conditions not expected to recur |
- Non-clear cell will be limited to 15% | •No disorders requiring steroids >10 mg prednisone or its equivalent daily |
•Planned for nephrectomy (partial or radical) | |
•ECOG performance status 0 or 1 | •Limitations on prior cancers |
•Adequate end organ function—hematologic, hepatic, renal, neurologic |
*See www.clincialtrials.gov for full listing.