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

NCT05239533 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	9
Start date	2022-02-16
Completion	2027-03

Conditions

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

Interventions

• 177Lu-labeled-girentuximab
• Nivolumab
• 89Zr-girentuximab PET/CT
• 177Lu whole body (WB) planar and SPECT/CT scans

Primary outcomes

• Maximal tolerated dose (MTD) of 177Lu-girentuximab — 24 (+/- 2) weeks
  To determine the maximal tolerated dose (MTD) of 177Lu-girentuximab when given in combination with nivolumab (safety lead-in)
• Overall Response Rate/ORR — 24 (+/- 2) weeks
  efficacy of the combination at the MTD of 177Lu-labelled girentuximab in patients with advanced ccRCC as assessed by best ORR by 24 (+/- 2) weeks by Response Evaluation Criteria In Solid Tumors (RECIST v1.1).

Countries

United States