This is a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.
Male or female, age ≥ 18 years old
Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.
Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.
Expected survival period is at least 3 months.
Documented central nervous system metastases.
Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment.
Has received major surgery (grade 3 or 4 as defined in the Measures for the Administration of Clinical Application of Medical Technology) within 28 days before the first dose of study treatment and has not yet recovered from which; or any planned curative surgery for renal cell carcinoma during the study.
History of another malignancy within 5 years before the first dose of study treatment, except for Lung carcinoma in situ, low-risk early-stage prostate cancer, or cured basal-cell carcinoma, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.
Parallel
IBR854
DrugEvery 21 days is one cycle, and IBR854 will be dosed in a route of intravenous infusion on day 1 and day 8 of each cycle with a fixed dose of 9.0×10\^9 cells.
Pazopanib
DrugPazopanib will be dosed orally once daily without food (at least 1 hour before or 2 hours after a meal) with a fixed dose of 800mg.
Progression-free Survival (PFS)
The time from randomization to the first radiologically confirmed disease progression or death from any cause (whichever occurs first).
Overall Survival (OS)
The time from randomization to death from any cause (whichever occurs first).
Objective Response Rate (ORR)
Proportion of participants who have a CR or PR per RECIST 1.1.
Disease Control Rate (DCR)
Proportion of participants who have a CR, PR or SD per RECIST 1.1.
Duration of Response (DoR)
The time from the date of first response until date of the first radiologically confirmed disease progression per RECIST 1.1.
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