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.

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuliz Ozgun

About this trial

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

Eligibility criteria

Qualifiers

Age 18 or older

Able to provide informed consent

Histologically confirmed advanced clear cell kidney cancer

Eligible for standard-of-care nivolumab/ipilimumab regimen

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nivolumab & Ipilimumab
  • Nivolumab + Ipilimumab

Treatment groups

142 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Guliz Ozgun

Lead sponsor

British Columbia Cancer Agency

Sponsor institution

British Columbia Cancer Agency

Collaborator