BMS Checkmate: A Study for Kidney Cancer Patients after Nephrectomy

Lay title: BMS Checkmate: A Study for Kidney Cancer Patients after Nephrectomy

Technical Title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

Disease Type: Patients with renal cell carcinoma (a type of kidney cancer) who are planned to have a nephrectomy (surgical removal of the kidney)

Basic information: The purpose of this study is to compare the effectiveness, safety, and tolerability of an investigational drug combination in patients with localized kidney cancer that have had their tumors completely removed, but are at risk of having their cancer return. The drug combination includes two drugs: nivolumab (also known as OPDIVO) and ipilimumab (also known as Yervoy).

Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab is approved for the treatment of certain types of cancer, including skin, kidney, blood, and lung. Ipilimumab is approved for the treatment of metastatic melanoma. The combination of nivolumab and ipilimumab is also approved for the treatment of advanced kidney cancer that has spread to other parts of the body and metastatic melanoma.

The study has two parts. In Part A, patients will be randomized to one of two groups: (1) receive combination of nivolumab and ipilimumab, or (2) receive placebo.

In Part B, patients will randomized to one of three groups: (1) receive combination of nivolumab and ipilimumab, (2) receive placebo, or (3) receive nivolumab alone.

The study is blinded, which means that neither you nor your study doctor will know which study treatment you are receiving.

Research Procedures (not a complete list):
You will return to clinic every 2 weeks to receive study medication and complete study procedures. Procedures include questionnaires, a physical exam, blood test, and assessment of side effects. You will come to clinic for up to 12 cycles, or 6 months.

Eligibility Criteria (Not a complete list):
Inclusion Criteria:

• Diagnosis of renal cell carcinoma with mostly clear cell histology
• Nephrectomy within 4-12 weeks of first study treatment
• Able to provide 10-20 unstained kidney tumor slides, preferably from nephrectomy

Exclusion Criteria:

• No metastases
• No diagnosis of hepatitis B, hepatitis C, or HIV
• No prior treatment with anti-PD-1, anti-PD-L1m anti-PD-L2, or anti-CTLA-4 antibodies
• No prior systemic anti-cancer treatment (such as chemotherapy) for kidney cancer

For More Detailed Information, Contact:

• Brian Shuch, MD, Principal Investigator, Associate Professor of UCLA Urology
• Sara Rodriguez, Study Coordinator, (310) 794-2877

Read more about this study (NCT03138512) on ClinicalTrials.gov.