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

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 - FIRST-RCC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060476

Enrollment

400

Registered

2026-01-27

Start date

2026-01-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
PFS(Progression-free Survival) in first-line treatment	—

Secondary

Measure	Time frame
Outcomes in the first-line setting OS(Overall Survival), PFS-2(Progression-free Survival-2), ORR(Overall Response Rate), DOR(Duration of Overall Response), DCR(Disease Control Rate), TTF(Time to Treatment Failure), BOR(Best Overall Response), TTR(Time to Response), DOT(Duration of Therapy), TTNT(Time to Next Treatment), Reasons for treatment discontinuation, RDI(Relative Dose Intensity), Rate of dose modifications(reduction, interruption, discontinuation), Safety Outcomes in second-line treatment and beyond PFS by line of therapy, BOR by line of therapy, DOT by line of therapy, TTNT, Reasons for treatment discontinuation Treatment sequence	—

Measure

Time frame

Outcomes in the first-line setting OS(Overall Survival), PFS-2(Progression-free Survival-2), ORR(Overall Response Rate), DOR(Duration of Overall Response), DCR(Disease Control Rate), TTF(Time to Treatment Failure), BOR(Best Overall Response), TTR(Time to Response), DOT(Duration of Therapy), TTNT(Time to Next Treatment), Reasons for treatment discontinuation, RDI(Relative Dose Intensity), Rate of dose modifications(reduction, interruption, discontinuation), Safety Outcomes in second-line treatment and beyond PFS by line of therapy, BOR by line of therapy, DOT by line of therapy, TTNT, Reasons for treatment discontinuation Treatment sequence

—

Countries

Japan

Contacts

Public ContactHajime Tanaka

Institute of Science Tokyo Department of Urology

hjtauro@tmd.ac.jp03-3813-6111

Outcome results