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

NCT05239533 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-01-14

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Darren Feldman, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05239533 on ClinicalTrials.gov