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

  • STATUS
    Recruiting
  • End date
    Mar 24, 2024
  • participants needed
    29
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 24 March 2022
ct scan
platelet count
cancer
systemic therapy
carcinoma
serum bilirubin
bone metastases
nivolumab
kidney cancer
nephrectomy
clear cell renal cell carcinoma

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.

Details
Condition Clear Cell Renal Cell Carcinoma, Kidney Cancer, Advanced Renal Cell Carcinoma
Treatment Nivolumab, 177Lu-labeled-girentuximab, 89Zr-girentuximab PET/CT, 177Lu whole body (WB) planar and SPECT/CT scans
Clinical Study IdentifierNCT05239533
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Locally advanced unresectable or metastatic RCC with a component of clear cell histology i. Archival tumor tissue will be requested from patients who have undergone biopsy or tumor resection as part of routine clinical care prior to study participation to confirm diagnosis. Patients may undergo pre-treatment biopsy during the screening period if archival tissue is insufficient for baseline analysis
Tumor specimen may include nephrectomy or metastatic site specimen
At least one evaluable metastatic lesion as defined by RECIST 1.1 on zirconium-89 (89Zr)-girentuximab PET/CT
At least one prior line of systemic therapy, including at least one prior treatment with anti PD-1 or PD-L1antibody
Age ≥18 years
KPS ≥ 70
Adequate performance status and adequate organ function
ANC ≥ 1500 cells/μL
WBC ≥ 2500/μL
Lymphocyte count ≥ 500/μL
Platelet count ≥100,000/μL (without transfusion within 2 weeks prior to Cycle
Day 1; thrombopoietic agent use is allowed)
Hemoglobin ≥9.0 g/dL (patients may be transfused or receive erythropoietic treatment to meet this criterion)
AST, ALT, and alkaline phosphatase ≤ 2.5 x ULN, with the following exceptions
Patients with documented liver metastases: AST and/or ALT ≤ 5 x ULN
Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN
Serum bilirubin ≤ 2 x ULN
Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled
INR and aPTT ≤ 1.5 x ULN
This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose
Creatinine clearance ≥ 40mL/min, as measured by the Cockcroft-Gault formula
Women of childbearing potential and men are advised to practice double-barrier contraception until a minimum of 6 months after IV 89Zr-girentuximab or177Lu-girentuximab administration. Women of childbearing potential are advised to practice double-barrier contraception until a minimum of 5 months after nivolumab
Signed consent form by the participant or a legally authorized representative (LAR)

Exclusion Criteria

Renal cell carcinoma with no histological evidence of any component of clear cell features. Note: Unclassified RCC with clear cell features is eligible for inclusion
Prior treatment with 177Lu- girentuximab
Known hypersensitivity to girentuximab or DFO (desferoxamine)
Exposure to murine or chimeric antibodies within the last 5 years
Previous administration of any radionuclide within 10 half-lives of the same
Radiotherapy for RCC within 14 days prior to Cycle 1, Day 1 except for single-fraction radiotherapy given for the indication of pain control which should be given at least 48 hours prior to C1D1
Active untreated metastases to the brain >1cm or symptomatic (of any size)
Active untreated metastases to the spinal cord or leptomeningeal disease
Patients with uncontrolled pain who are not on a stable pain regimen
History of steroid requirement > 10 mg daily prednisone in the past 2 years for autoimmune comorbidities
Prior checkpoint inhibitor therapy discontinued due to immune related adverse events
Anti-cancer therapy within 2 weeks prior to enrollment
Uncontrolled hypercalcemia (≥ 1.5 mmol/L ionized calcium or Ca ≥ 12 mg/dL or corrected serum calcium ≥ ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
Malignancies other than RCC within 3 years prior to Cycle 1, Day 1, except for those with a negligible risk of metastasis or death, treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent, non-muscle-invasive urothelial carcinoma)
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
HIV infection if not well-controlled with antiretroviral therapy
Patients with active or chronic hepatitis B or hepatitis C infection
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina, or EF < 50%
Patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
History of stroke or transient ischemic attack within 6 months prior to Cycle 1, Day 1\
Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Cycle 1, Day 1
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Major surgery within 4 weeks prior to enrollment (biopsy or line placement can be performed up to 24 hours prior to enrollment)
Pregnant and lactating women
Patients in whom nivolumab treatment is not feasible for any reason (including financial/insurance)
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