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.
Starting soon · Phase 3
Conditions studied: Advanced Kidney Cancer
In brief
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
Key facts
- Study ID
- NCT07338981
- Run by
- Guliz Ozgun
- People needed
- 142
- Starts
- 2026-04-01
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- ECOG performance status 0-2
- Ability to adhere to scheduled infusion times (Before 11:30 a.m. or after 1:30 pm)
You may not qualify if…
- 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
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- Patients who have traveled across ≥2 time zones within the past 14 days prior to randomization will be excluded, due to potential disruption of circadian rhythms (jet lag), which may affect chronotherapy-related endpoints.
- Patients with a clinically diagnosed sleep disorder, including but not limited to insomnia, obstructive sleep apnea, restless leg syndrome, or circadian rhythm sleep-wake disorders, that is moderate to severe, untreated, or poorly controlled, will be excluded.
Where it is running
- BC Cancer - Vancouver Cancer Centre — Vancouver, British Columbia, Canada
Full record on ClinicalTrials.gov
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