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Protocol No. EA8143

Principal Investigator Emamekhoo, Hamid

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Phase 3 Randomized Study Comparing Perioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

Objective The purpose of this study is to compare any good and bad effects of using nivolumab (also known as OPDIVO®), before and after the kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for kidney cancer that has been removed but is at risk for coming back.

Treatment Nivolumab is a drug that may help stimulate your immune system to attack any cancer cells that may remain after surgery. The study drug, nivolumab, is already FDA-approved for patients who have kidney cancer that has spread outside of the kidney to other organs or lymph nodes. The use of nivolumab in this study is investigational (not approved by the FDA) for your early stage of cancer where we do not know for sure if the disease has spread outside of the kidney.

Description This research study has two study groups. If you are assigned to Group 1, you will get the study drug, nivolumab before and after surgery for a total of 14 doses. Nivolumab is administered by an intravenous (IV) infusion over 30 minutes once every two weeks for two doses before surgery. After recovering from surgery, you will receive it every 2 weeks for 3 months then monthly for 6 more months for a total of 9 months of treatment after surgery. Treatment will continue for a maximum of 9 months after surgery (12 doses of nivolumab) or until you have side effects, your cancer returns, or you decide to stop. If you are assigned to Group 2, you will undergo surgery to remove the kidney cancer, followed by standard post-operative follow-up monitoring for return of the cancer with radiology scans, doctor’s visits, bloodwork and physical exams. You will not receive nivolumab. A computer will assign you by chance to one of the two groups in the research study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal (50%) chance of being placed in either group. You and your doctor will be informed of your group.

Key Eligibility
  • Preoperative biopsy for confirmation of RCC must be performed within four (4) months prior to randomization
  • Clinical stage ≥ T2NxM0 disease or TanyN+ disease for which radical or partial nephrectomy is planned
  • Patients must have no clinical or radiological evidence of distant metastases (M0)
  • No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
  • Age ≥ 18 years
  • Women must not be pregnant or breast-feeding, as the effects of nivolumab on the developing human fetus are unknown
  • Patient must have no prior history of RCC that was resected with curative intent within the past 5 years
  • Patients with active known or suspected autoimmune disease are excluded
  • Patients with ongoing condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications are excluded
  • Patients with uncontrolled adrenal insufficiency are excluded
  • Patients with known chronic active liver disease or evidence of acute or chronic Hepatitis B Virus (HBV) or Hepatitis C (HCV) are excluded
  • Patients must not have a serious intercurrent illness, including ongoing or active infection requiring parental antibiotics
  • No known evidence of HIV infection, since the effects of nivolumab on anti-retroviral therapy have not been studied
  • No major surgery within 28 days prior to randomization
  • Patients currently enrolled in other clinical trials testing a therapeutic intervention are excluded

Applicable Disease Sites Kidney

Therapies Involved Immunotherapy

Drugs Involved BMS-936558 (Nivolumab); Nivolumab; Opdivo (Nivolumab)

Status Open

Participating Institutions Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; UW Hospital and Clinics; UWCCC 1 South Park