Intermittent Therapy in Metastatic Renal Cell Carcinoma Patients Treated With Ipilimumab and Nivolumab

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT03126331
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab monotherapy will be administered dosed at 480mg IV over 30 minutes for all patients every 4 weeks, regardless of weight (when given in combination with ipilimumab, the dose of nivolumab is 3mg/kg every 3 weeks). Tumor assessed after 12 weeks If tumor decreases by 10% or more, then hold drug for 12 week and test tumor again. Continue treatment if tumor is not decreased by 10% or more.
  • Ipilimumab — DRUG
    Ipilimumab is dosed at 1mg/kg over 30 minutes every 3 weeks

Study Details

This study is being done with patients with advanced kidney cancer (also called renal cell carcinoma or RCC). This is a research study involving the use of the drug Nivolumab (also known as Opdivo®). Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing it to recognize and help destroy cancer cells. In many countries (including the United States, European Union and Japan) Nivolumab is approved to treat certain cancer types. The purpose of the study is to test the safety and effectiveness of nivolumab in patients with advanced RCC when given intermittently. Nivolumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced kidney cancer, non small cell lung cancer, classical Hodgkin Lymphoma and Metastatic Melanoma. Nivolumab is FDA-approved for advanced RCC because has been shown to shrink RCC tumors that have spread outside the kidney.

Key Dates

Start date
Aug 3, 2017
Status verified
Mar 2024
Primary completion
Oct 24, 2023
Completion
Oct 24, 2023

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I: Intermittent Nivolumab
    Nivolumab monotherapy. Participants who have initial 10% or greater tumor burden reduction will discontinue nivolumab until they experience a pre-specified disease progression at which time nivolumab will be restarted
  • Experimental: Cohort II: combination ipilimumab/nivolumab
    Combination of ipilimumab/nivolumab for previously untreated intermediate and poor risk mRCC Includes participants treated front-line ipilimumab/nivolumab. Participants with treatment-naïve mRCC who receive up to four doses of induction ipilimumab/nivolumab and 24 weeks (+/- 8 weeks; minimum 3 infusions) of maintenance nivolumab and achieve stable disease (SD), complete response (CR), or partial response (PR) will be eligible for inclusion. Participants who achieve SD will continue with nivolumab maintenance per standard of care while those who achieve a PR or CR will enter an observation period off therapy. Upon disease progression, participants will be re-challenged with combination ipilimumab/nivolumab.

Primary Outcome Measure

the proportion of patients who receive intermittent therapy [ Time Frame: Expected duration 5.5 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

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