JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF CABOZANTINIB PLUS NIVOLUMABIN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC RENAL CELL CARCINOMA

JAPANESE PROSPECTIVE REAL WORLD REGISTRY OF CABOZANTINIB PLUS NIVOLUMABIN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC RENAL CELL CARCINOMA - JACUMET study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050778

Enrollment

200

Registered

2023-04-06

Start date

2023-04-30

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

advanced or metastatic renal cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with histologically confirmed ccRCC(Cohort A) or nccRCC(Cohort B). Includes patients with sarcomatoid features in both cohorts 2)Advanced (not amenable to curative surgery) or metastatic RCC 3)Plan to receive cabozantinib + nivolumab combination therapy 4) No prior systemic therapy for RCC 5) Karnofsky Performance Status (KPS) grade >= 70% 6) Measurable disease as per RECIST v1.1 per investigator. 7)Signed Written Informed Consent

Exclusion criteria

Exclusion criteria: 1)Synchronous or metachronous (within 3 years) malignancies. 2)Surgery prior to initiation of cabozantinib + nivolumab combination therapy with incomplete wound healing or continued postoperative complications 3) Radiotherapy within 14 days before starting cabozantinib + nivolumab combination therapy. Must be fully recovered from radiotherapy

Design outcomes

Primary

Measure	Time frame
ORR by cohort	—

Countries

Japan

Contacts

Public ContactKazunori Fujita

Kindai University School of Medicine Urology

kfujita@med.kindai.ac.jp072-366-0221

Outcome results