Nivolumab in Treating Patients With High-Risk Kidney Cancer Before Surgery

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02595918
Phase
PHASE1
Status
Terminated

Conditions

  • Clear Cell Renal Cell Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Stage I Renal Cell Cancer AJCC v6 and v7
  • Stage II Renal Cell Cancer AJCC v7
  • Stage III Renal Cell Cancer AJCC v7
  • Stage IV Renal Cell Cancer AJCC v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metastasectomy — PROCEDURE
    Undergo metastasectomy
  • Nephrectomy — PROCEDURE
    Undergo nephrectomy
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This pilot phase I trial studies the side effects of nivolumab and how well it works in treating patients with high-risk kidney cancer before surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
May 19, 2016
Status verified
Oct 2020
Primary completion
Aug 1, 2020
Completion
Aug 1, 2020

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab)
    Patients receive nivolumab IV over 30 minutes on days -56, -42, -28, and -14 in the absence of disease progression or unacceptable toxicity. Patients then undergo nephrectomy or metastasectomy on day 0.

Primary Outcome Measure

Feasibility of a patient to receive at least 3 doses of nivolumab and complete surgery without significant delay attributable to nivolumab therapy [ Time Frame: Up to 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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