PDIGREE / A031704 — Response-adaptive nivolumab/ipilimumab then nivolumab, with or without cabozantinib, in advanced RCC
Phase 3 · Renal Cell Carcinoma, Kidney Cancer
Population
Previously untreated metastatic clear cell renal cell carcinoma.
Primary Endpoint
Overall survival
Rationale
Front-line ipilimumab-nivolumab produces some complete responses, but many patients progress. PDIGREE uses an adaptive design — intensifying with cabozantinib for non-responders while sparing responders extra toxicity — to personalize therapy based on early response.
What It Could Change
Could establish a response-guided treatment algorithm for advanced kidney cancer.