NCT07338981
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.
Not Yet Recruiting · Phase 3 · Guliz Ozgun · registry updated 2026-01-14
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
Inclusion
- Participants must meet all of the following criteria to be eligible for participation in this trial. Waivers to the inclusion criteria will NOT be allowed.
- Age 18 or older
- Able to provide informed consent
- Histologically confirmed advanced clear cell kidney cancer
- Eligible for standard-of-care nivolumab/ipilimumab regimen
- Measurable disease per RECIST 1.1
Exclusion
- Participants are excluded from the trial if any of the following criteria apply. Waivers to the exclusion criteria will NOT be allowed.
- Non-clear cell RCC histology
- Concurrent malignancy requiring active systemic therapy, unless disease-free for at least 2 years
- Inability to comply with protocol-specified infusion timing for the first 4 cycles
- Night shift workers
- Clinical evidence of new or enlarging brain metastasis or carcinomatous meningitis