Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer
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ClinicalTrials.gov Identifier: NCT04394975 |
Recruitment Status :
Active, not recruiting
First Posted : May 20, 2020
Last Update Posted : April 26, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | May 12, 2020 | ||||
First Posted Date ICMJE | May 20, 2020 | ||||
Last Update Posted Date | April 26, 2023 | ||||
Actual Study Start Date ICMJE | August 20, 2020 | ||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PFS assessed by IRC per RECIST 1.1. [ Time Frame: 3 years ] To compare the progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by independent review committee (IRC) in subjects treated with Toripalimab plus axitinib vesus sunitinib monotherapy as a first-line treatment for advanced RCC.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
Biomarker [ Time Frame: 2 years ] Correlation between biomarker (PD-L1) and the efficacy of Toripalimab
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Axitinib Versus Sunitinib Monotherapy in Advanced Renal Cell Cancer | ||||
Official Title ICMJE | A Phase III, Randomized, Open-label, Active Controlled, Multicenter Study on Toripalimab Combined With Axitinib Versus Sunitinib Monotheraphy as a First-Line Treatment for Unresectable or Metastatic Renal Cell Carcinoma (RCC) | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Primary Disease: Unresectable or Metastatic Renal Cell Carcinoma Focus of the Study:PFS Assessed by IRC Per RECIST 1.1 | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
421 | ||||
Original Estimated Enrollment ICMJE |
560 | ||||
Estimated Study Completion Date ICMJE | June 30, 2023 | ||||
Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion criteria:
Bone marrow function (without blood or blood products transfusion, without hematopoietic stimulating factor or other medication to improve blood cell count within 2 days prior to first dose of study drug): Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelets ≥ 100×109/L. Hemoglobin ≥ 9.0g/dL or ≥ 5.6mmol/L. Renal function: Serum creatinine ≤ 1.5×ULN Hepatic function: Serum total bilirubin ≤1.5×ULN or total bilirubin levels >1.5×ULN with direct bilirubin ≤ ULN. AST and ALT ≤2.5 × ULN, ≤5×ULN in those with hepatic metastasis. Endocrine function: Normal thyroid stimulating hormone, or abnormal TSH whilst normal FT3 and FT4. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, Subjects receiving anticoagulant therapy (e.g., heparin or warfarin) may participate in the study with PT or aPTT levels within the scope of the proposed therapy and monitored during study treatment.Left ventricular ejection fraction (LVEF) ≥ 50%. 8. Being willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 10. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first treatment dose. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use a highly effective methods of contraceptive throughout the study and for 180 days after the last dose of study therapy. Exclusion criteria:Bone marrow functiPatients with any of the following conditions will not be included in the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04394975 | ||||
Other Study ID Numbers ICMJE | JS001-036-Ⅲ-RCC | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Shanghai Junshi Bioscience Co., Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Shanghai Junshi Bioscience Co., Ltd. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Shanghai Junshi Bioscience Co., Ltd. | ||||
Verification Date | April 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |