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.

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 be able to join if…

• 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 this trial is running

• BC Cancer - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

Who to contact

Dr. Guliz Ozgun, MD · 604-877-6000 · guliz.ozgun@bccancer.bc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07338981.