A phase II study assessing the feasibility and clinical efficacy of adaptive immunotherapy combination with VEGFR-TKI in patients with advanced renal cell carcinoma.

Cancer research · Renal cell carcinoma

The study will evaluate whether an adaptive multi‑drug therapy approach using pembrolizumab and axitinib is feasible, safe, and acceptable to patients with metastatic or unresectable locally advanced clear‑cell renal‑cell carcinoma.

A phase‑II trial evaluating the feasibility, patient acceptability, safety and preliminary efficacy of response‑based adaptive therapy using pembrolizumab + axitinib in patients with metastatic or unresectable locally advanced clear‑cell renal‑cell carcinoma (ccRCC). The study will monitor patients’ tolerability, quality of life, adverse events, economic burden and duration of disease control, and determine whether adaptive dosing is safe and well tolerated.| In this early‑phase design, patients start on standard dosing of pembrolizumab + axitinib; if tumour shrinkage ≥20 % is observed the therapy is paused until tumour progression, then recommenced. The trial aims to inform whether a larger comparative study is justified.

Clear‑cell RCC has high morbidity and mortality, and current first‑line combination immunotherapy/VEGFR‑TKI regimens are associated with significant toxicity and cost. Adaptive therapy, which modulates drug exposure based on tumour response, may reduce cumulative toxicity while maintaining disease control, potentially improving patient quality of life and lowering treatment costs.

Evidence level: Feltételezés / hírjelzés. Nincs önálló tudományos bizonyíték.

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