NCT05663710

Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).

Detailed description

Primary Objectives: * To determine safety of combination 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC. * To evaluate CR rate in the combination of 177Lu girentuximab with nivolumab plus cabozantinib in subjects with previously untreated ccRCC. 2. CR rate by RECIST 1.1 by investigator Secondary Objectives: * To evaluate ORR of 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC. * To evaluate PFS of 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC.

Conditions

• Advanced Cancer
• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	177Lu girentuximab	Given by IV (vein)
DRUG	Nivolumab	Given by IV (vein)
DRUG	Cabozantinib	Given by PO
DRUG	ArabinoFuranosylGuanine [18F]F-AraG	Given by IV (vein)

Timeline

• Start date: 2023-06-30
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2022-12-23
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study