NCT07338981Not yet recruitingPhase 3
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.
(CHRONO-RCC) Time-of-day-Dependent Administration of Dual Immune Check Point Inhibitors (ICI) in Advanced Kidney Cancer
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- First submitted
- 5 Dec 2025
- Start date
- Feb 2027
- Primary completion date
- Dec 2031
- Lead sponsor
- Guliz Ozgun
- Diseases
- Kidney cancer
- NCT number
- NCT07338981
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 142
- From Feb 2027 to the primary completion date, Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent malignancy requiring active systemic therapy, unless disease-free for at least 2 years
- 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.
Other illness
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- 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.
Other
- 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
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Cancer - Vancouver Cancer Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.