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

RECRUITINGPHASE1/PHASE2

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

NCT05663710•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515
•2. Age ≥ 18 years
•3. Has locally advanced or metastatic RCC with predominantly clear cell subtype
•4. Has at least one measurable lesion as defined by RECIST version 1.1
•5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
•6. Has adequate organ function defined as follows:
•a. Absolute neutrophil count ≥ 1,500/µL, Hgb level ≥ 9 g/dL and platelet count (Plt) i. ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; b. Creatinine clearance ≥ 40 mL/min/1.73m2 c. Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin i. (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease
•7. Women of child beariring potential must have a negative serum preganancy test within 7 days before first study drug administration
•8. Female patients of child bearing potential, or a male patients with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use a highly effective method of contraception during screening, during the period of drug administration and for 120 days after stopping study drug administration. Highly effective contraception methods include the following:
•1. Total abstinence (defined as refraining from heterosexual intercourse during the entire period outlined above),
+6 more criteria

Exclusion Criteria

•1. Has received treatment with any frontline systemic therapy for metastatic RCC
•2. Has a history of leptomeningeal disease or spinal cord compression
•3. Has a history of autoimmune disease requiring active therapy
•4. Has a history of brain metastases except:
•1. Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND
•2. Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs
•6. Has uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure (BP) \> 140/90 with or without antihypertensive treatment
•7. Has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure
•8. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor
•9. Has an active infection requiring systemic treatment
+13 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

June 30, 2023

Primary Completion Date

October 30, 2027

Completion Date

October 30, 2027

Last Updated

October 6, 2025

Enrollment

100

ESTIMATED participants

Conditions

Advanced CancerClear Cell Renal Cell Carcinoma

Interventions

177Lu girentuximab

DRUG

Nivolumab

DRUG

Cabozantinib

DRUG

ArabinoFuranosylGuanine [18F]F-AraG

DRUG

Contacts

Eric Jonasch, MD

CONTACT

(713) 563-7232 ejonasch@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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