Tokyo, Jan. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060476) titled 'A Multicenter Retrospective Study on the Efficacy and Safety of First-Line Treatments (Nivolumab plus Cabozantinib and Pembrolizumab plus Lenvatinib) for Advanced/Metastatic Renal Cell Carcinoma' on Jan. 27.
Study Type:
Observational
Primary Sponsor:
Institute - Institute of Science Tokyo
Condition:
Condition - Renal Cell Carcinoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To explore the efficacy and safety of nivolumab plus cabozantinib and pembrolizumab plus lenvatinib as optimal first-line treatments for patients with advanced or metastatic renal cell carcinoma.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Patients aged 18 years or older at the initiation of first-line treatment for advanced or metastatic renal cell carcinoma
2.Patients who have not refused to participate in the study following disclosure of study information via an opt-out method
3.Patients with histologically diagnosed renal cell carcinoma
4.Patients who initiated IO+TKI combination therapy (nivolumab plus cabozantinib or pembrolizumab plus lenvatinib) as first-line treatment for advanced or metastatic renal cell carcinoma between April 1, 2022, and September 30, 2023
Key exclusion criteria - 1.Patients who had malignancies other than renal cell carcinoma within 2 years prior to the initiation of first-line treatment for advanced or metastatic renal cell carcinoma. However, patients with carcinoma in situ or intramucosal carcinoma that have been curatively treated by local resection or are considered curable are excluded from this restriction.
2.Patients with a history of treatment with immune checkpoint inhibitors prior to the first-line treatment for advanced or metastatic renal cell carcinoma.
3.Patients deemed inappropriate for the study by the principal investigator or investigator due to reasons such as insufficient medical records.
Target Size - 400
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 14 Day
Date of IRB - 2026 Year 01 Month 23 Day
Anticipated trial start date - 2026 Year 01 Month 27 Day
Last follow-up date - 2026 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069060
Disclaimer: Curated by HT Syndication.