The Impact of Time-of-day-Dependent Administration of Nivolumab-Ipilimumab (ICI/ICI) Combination on Overall Survival in Adults With Advanced Kidney Cancer: A Pragmatic Multicenter, Randomized Controlled Trial.

StatusNot Yet Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2030 → Dec 2031
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Record History

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  1. Primary completion pushed from Dec 2030 to Dec 2031 Show 7 more changesShow less
    • Start date: Apr 2026 to Feb 2027
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from Dec 2032 to Dec 2033
    • Interventions: Nivolumab & Ipilimumab (Drug), Nivolumab + Ipilimumab (Drug) to Nivolumab & Ipilimumab (Drug), Nivolumab + Ipilimumab (Drug)
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Publications: details revised at 9 of 9 entries
  2. Study First Submitted
  • 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.
Guliz Ozgun
2 trials monitored
See 1 trial at risk
Kidney Cancer
891 trials monitored
See 72 trials at risk
The goal of this clinical trial is to learn if the timing of treatments plays a role in how effective the standard-of-care drugs nivolumab/ipilimumab (ICI/ICI) works to treat adults with advanced kidney cancer. The trial will also learn if time-of-day reduces ICI/ICI side-effects. Researchers will compare ICI/ICI given in the morning (before 11:30am) vs in the afternoon (after 1:30pm), to see if circadian rhythm effects how ICI/ICI works to treat advanced kidney cancer. Participants will be randomized in Arm A or Arm B to receive drugs ICI/ICI either in the morning (Arm A) or afternoon (Arm B) as part of their standard-of-care treatment for advanced kidney cancer. Participants will: * Visit the clinic either in the morning (Arm A) or afternoon (Arm B) to receive ICI/ICI treatment as part of their regular medical care for advanced kidney cancer * Frequency of visits will follow standard-of-care guidelines
Trial Details
NCT Number NCT07338981
Lead Sponsor Guliz Ozgun
Collaborators: British Columbia Cancer Agency
Conditions
(from sponsor)		 Advanced Kidney Cancer
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov