Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Suni… (NCT04394975) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer
China421 participantsStarted 2020-08-20
Plain-language summary
This is a randomized, open-label, controlled, multicenter, phase III trial to compare the efficacy and safety of Toripalimab in combination with axitinib to sunitinib monotherapy as a first-line therapy for advanced RCC. Eligible patients will be randomized 1:1 to receive the combination therapy of Toripalimab and axitinib or sunitinib monotherapy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Fully understand and be willing to provide written informed consent.
✓. Male or female with age ≥ 18 years and \<80 years.
✓. Have received no prior systemic therapy after previous metastasis for RCC, histologically confirmed diagnosis of unresectable, recurrent or metastatic RCC with clear cell component with or without sarcomatoid features,Prior cytokine therapy was allowed.
✓. The IDMC score was medium to high risk.
✓. Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression has been demonstrated.
✓. Provide archival tumor tissues or newly obtained biopsies if patients participate in the exploratory study.
✓. ECOG PS 0 or 1.
✓. Adequate function of vital organs:
Exclusion criteria
✕. PriorAnti-PD-1, PD-L1 or CTLA-4 agents ).
✕. Prior systemic anti-cancer therapy after metastasis (e.g., VEGF/VEGFR or mTOR targeting agents, including (but not limited to) sunitinib, axitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, bevacizumab or everolimus.
✕. Progression or recurrence during neoadjuvant/adjuvant therapy for renal cell cancer or within 12 months after the last dose treatment.
. Has participated or is currently participating in a trial of investigational agent within 4 weeks prior to the first dose of study treatment, unless observational (non-interventional) clinical study or follow-up period of interventional study.
✕. Had major surgery (judged by investigators) within 4 weeks prior to the first dose of study treatment or has not recovered from prior surgery.
✕. Has traditional Chinese medicine or Chinese patent medicine preparation with anti-cancer indication within 2 weeks prior to the first dose of study treatment.
✕. Requiring corticosteroids (Prednisone \>10 mg/day or equivalent analogue) or other immunosuppressive agents within 2 weeks prior to the first dose of study treatment. Patients without active autoimmune disease using inhaled prednisone \>10 mg/day will not be excluded from the study.
✕. Has a history of organ transplantation or required long-term treatment with corticosteroids.