Nivolumab and Ipilimumab With and Without Camu Camu for the Treatment of Patients With Metastatic Renal Cell Carcinoma

StatusSuspended
PhasePhase 1
Started

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Record History

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  1. Sponsor's reason: DSMC: Delinquent PMT report due 09/15/2026. Study was closed to accrual before suspension applied. to 09/29/2026 DSMC: Opened in order to apply suspension.
  2. Trial status changed: Active, Not Recruiting → Suspended Sponsor's reason: DSMC: Delinquent PMT report due 09/15/2026. Study was closed to accrual before suspension applied.
    • Eligibility criteria shortened, about 70 words
    • Secondary endpoints: details revised at 3 of 3 entries
  3. Primary and study completion pushed from Jun 23, 2026 to May 25, 2027v8
  4. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 31
    v7
  5. Primary and study completion dates: Mar 14, 2026 to Jun 23, 2026v6
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  1. Trial status: Recruiting to Suspended Sponsor's reason: met goal
    • Site details revised
    v5
  2. Trial status: Suspended to Recruiting
    • Site details revised
    v4
  3. Trial status: Recruiting to Suspended Sponsor's reason: DSMC
    • Site details revised
    v3
  4. Primary and study completion dates: Jan 8, 2025 to Mar 14, 2026
    • Start date changed from estimate of Sep 25, 2023 to Oct 6, 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I trial tests the safety, side effects, and best dose of camu camu when used in combination with nivolumab and ipilimumab in treating patients with kidney cancer that has spread to other places in the body. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Camu camu is a prebiotic that may have a beneficial effect on the immune system. Giving camu camu in combination with nivolumab and ipilimumab may kill more tumor cells than nivolumab and ipilimumab alone in patients with metastatic kidney cancer.
Trial Details
NCT Number NCT06049576
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
Related terms Carcinoma, Renal Cell
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov