NCT05239533

Study of Nivolumab in Combination With 177Lu-girentuximab for Kidney Cancer

A Phase 2 Open-label Study of Nivolumab Combined With Lutetium 177-Labeled Anti-Carbonic Anhydrase IX Monoclonal Antibody Girentuximab in Patients With Clear Cell Advanced Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the combination of 177Lu-girentuximab and nivolumab is a safe and effective treatment for advanced clear cell renal cell carcinoma/ccRCC that has the CAIX protein.

Conditions

• Clear Cell Renal Cell Carcinoma
• Kidney Cancer
• Advanced Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	177Lu-labeled-girentuximab	The initial starting dose/Dose Level 1 of 177Lu-labeled-girentuximab is 1804 MBq/m2. if 0/3 or 1/6 DLTs, participants will be treated at Dose Level 2 177Lu-girentuximab 2405 MBq/m2. \>/= 2/6 DLTs, Dose Level -1 is 177Lu-girentuximab 1353 MBq/m2 Once the MTD is established, a Simon two-stage optimal design will commence.
DRUG	Nivolumab	Nivolumab 240mg q2wk
DIAGNOSTIC_TEST	89Zr-girentuximab PET/CT	All patients will undergo a 89Zr-girentuximab PET/CT scan prior to every 177Lu-girentuximab administration
DIAGNOSTIC_TEST	177Lu whole body (WB) planar and SPECT/CT scans	177Lu whole body (WB) planar and SPECT/CT scans will be performed after each administration of 177Lu-girentuximab

Timeline

• Start date: 2022-02-16
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2022-02-15
• Last updated: 2026-01-14

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study