Nivolumab + Ipilimumab for Renal Cell Carcinoma

Overseen By Dr. Guliz Ozgun, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Guliz Ozgun

Must be taking: Nivolumab, Ipilimumab

Disqualifiers: Non-clear cell RCC, Brain metastasis, Sleep disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

Adults over 18 with advanced clear cell kidney cancer can join this trial. They must be able to consent, have measurable disease, and a performance status showing they're still active. Participants need to follow the infusion schedule either in the morning or afternoon.

Inclusion Criteria

I am eligible for the nivolumab/ipilimumab treatment.

My cancer can be measured by scans.

I meet all the required criteria for the trial without exceptions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard-of-care therapy (ICI/ICI) administered either in the morning or afternoon based on randomization

24 months

Frequency of visits will follow standard-of-care guidelines

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Ipilimumab
• Nivolumab

Trial Overview

The study tests if taking nivolumab-ipilimumab (ICI/ICI) for kidney cancer at different times of day affects its effectiveness or side effects. Patients will randomly receive treatment either before 11:30am or after 1:30pm as part of their standard care.

How Is the Trial Designed?

Group I: Arm B: Afternoon ICI/ICI Treatment Active Control 1 Intervention

Participants will receive standard-of-care therapy (ICI/ICI) administered in the afternoon (after 1:30pm).

Group II: Arm A: Morning ICI/ICI Treatment Active Control 1 Intervention

Participants will receive standard-of-care therapy (ICI/ICI) administered in the morning (before 11:30am).

Who Is Running the Clinical Trial?

Guliz Ozgun

Lead Sponsor

British Columbia Cancer Agency

Collaborator

Trials

181

Recruited

95,900+