Actively Recruiting
Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
100
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
T
Telix Pharmaceuticals (Innovations) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).
CONDITIONS
Official Title
Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Age 18 years or older
- Locally advanced or metastatic renal cell carcinoma with predominantly clear cell subtype
- At least one measurable tumor lesion by RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function including neutrophil count 1,500/bcL, hemoglobin 9 g/dL, platelet count 100,000/bcL, creatinine clearance 40 mL/min/1.73m2, liver enzymes 3 times upper limit of normal, total bilirubin 1.5 mg/dL
- Negative pregnancy test within 7 days before first study drug for women of childbearing potential
- Agreement to use effective contraception during screening, treatment, and for 120 days after treatment if of childbearing potential or partner with childbearing potential
- Able to swallow oral medications
- Able to provide tumor tissue sample (archival or recent)
- Brain metastases allowed if controlled for at least one month, not life threatening, and other measurable disease present
You will not qualify if you...
- Prior treatment with any frontline systemic therapy for metastatic renal cell carcinoma
- History of leptomeningeal disease or spinal cord compression
- History of autoimmune disease requiring active therapy
- History of brain metastases unless treated and stable without ongoing steroid or anti-epileptic treatment
- Recent radiation therapy for bone metastases within 2 weeks or other external radiation within 4 weeks before study treatment
- Uncontrolled hypertension with blood pressure above 140/90 mmHg
- Major cardiovascular event within 6 months before study drug administration
- Significant cardiac, respiratory, psychiatric, or other medical conditions interfering with study participation
- Active infection requiring systemic treatment
- Participation in another therapeutic clinical trial
- Chronic use of strong CYP3A4 inducers or inhibitors
- Malabsorption due to prior gastrointestinal surgery or disease
- Gastrointestinal disorders with high risk of perforation or fistula, recent GI perforation or abscess
- Tumor invading or encasing major blood vessels
- Serious non-healing wounds, moderate to severe liver impairment, need for dialysis, or organ transplant history
- Major surgery within 2 months before study drug administration without full recovery
- Other invasive malignancy except certain skin or cervical cancers treated and disease-free for over 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eric Jonasch, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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