Study on Kidney Cancer Surgery Combined with Immunotherapy and Targeted Therapy
Sponsor: Mark Stein
ClinicalTrials ID:NCT04322955
This clinical trial is exploring whether using the immunotherapy drug nivolumab and the targeted therapy drug cabozantinib before kidney removal surgery can help more patients achieve a state where no visible kidney cancer is detected during treatment.
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Program Overview
The aim of this study is to find out if combining the immunotherapy drug nivolumab with the targeted therapy drug cabozantinib before kidney removal surgery can help patients with metastatic kidney cancer. This surgery, known as cytoreductive nephrectomy, is performed to reduce the amount of cancer in the body. The study will involve patients who have not received prior treatment for metastatic clear cell renal cell carcinoma. Participants will receive cabozantinib and nivolumab for about three months before undergoing surgery. If the treatment is beneficial, they may continue with the medication after surgery. The study will help researchers understand how these drugs affect the immune system and the potential benefits of combining surgery with these treatments.
Description
People with metastatic kidney cancer often receive medications to slow cancer growth. If the kidney where the cancer started is still present, it may be removed to reduce the tumor burden, a procedure called cytoreductive nephrectomy. This study involves using nivolumab, an immune checkpoint inhibitor, and cabozantinib, a targeted therapy, both approved for treating metastatic kidney cancer. Participants will receive these drugs for about three months before surgery. If they benefit from the treatment, they may continue taking the drugs after surgery. The study aims to understand the immune effects of these drugs on kidney tumors and the potential benefits of combining surgery with these treatments.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent and authorization for the release of personal health information.
- Must be 18 years or older.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have a diagnosis of metastatic renal cell carcinoma with a clear cell component, confirmed by imaging or pathology.
- Must have a measurable tumor in the kidney.
- Must not have received prior therapy for metastatic renal cell carcinoma.
- Must have adequate organ function as determined by specific lab tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for six months after treatment.
- Must be able to understand and comply with study procedures.
Exclusion Criteria
- Previous kidney removal surgery for cancer.
- Uncontrolled bleeding, high blood pressure, or heart disease.
- Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.
- Active brain metastases or epidural disease.
- Recent radiation therapy for bone or other metastases.
- Abnormal blood clotting tests.
- Need for certain blood thinners.
- Recent significant gastrointestinal bleeding.
- Recent coughing up of blood.
- Lung lesions or tumors in the digestive tract.
- Active or history of autoimmune disease requiring treatment.
- Need for systemic steroids or immunosuppressive medications.
- Severe heart conditions or uncontrolled high blood pressure.
- Recent severe infection or non-healing wounds.
- Recent major surgery.
- History of organ transplant.
- Uncontrolled thyroid issues.
- Inability to swallow tablets.
- Active infection requiring treatment.
- Pregnant or breastfeeding women.
- Other active or progressive cancers requiring treatment.
- Active central nervous system metastases.
- Recent treatment with investigational drugs.
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