NCT05239533View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

February 16, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Clear Cell Renal Cell CarcinomaKidney CancerAdvanced Renal Cell Carcinoma
Interventions
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

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activites), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER