Morning vs afternoon: can timing boost kidney cancer treatment?
NCT ID NCT07338981
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether getting standard immunotherapy drugs (nivolumab and ipilimumab) in the morning or afternoon makes a difference for people with advanced kidney cancer. About 142 adults will be randomly assigned to morning or afternoon infusions. Researchers will track survival, tumor response, and side effects to see if timing affects outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 142 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. 1. Age 18 or older 2. Able to provide informed consent 3. Histologically confirmed advanced clear cell kidney cancer 4. Eligible for standard-of-care nivolumab/ipilimumab regimen 5. Measurable disease per RECIST 1.1 6. ECOG performance status 0-2 7. Ability to adhere to scheduled infusion times (Before 11:30 a.m. or after 1:30 pm) Exclusion Criteria: Participants are excluded from the trial if any of the following criteria apply. Waivers to the exclusion criteria will NOT be allowed. 1. Non-clear cell RCC histology 2. Concurrent malignancy requiring active systemic therapy, unless disease-free for at least 2 years 3. Inability to comply with protocol-specified infusion timing for the first 4 cycles 4. Night shift workers 5. Clinical evidence of new or enlarging brain metastasis or carcinomatous meningitis 6. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial 7. 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. 8. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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BC Cancer - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
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