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TIME Trial: Immunotherapy Timing for Advanced Melanoma

This study, called the TIME Trial, is testing if giving immunotherapy drugs, ipilimumab and nivolumab, at specific times of day can improve treatment for advanced melanoma. Melanoma is a type of skin cancer. Researchers want to see if the timing affects how well the treatment works and if it's safe. You might be able to join if you have stage IV melanoma that cannot be removed by surgery, including cutaneous (skin), acral (hands/feet), or mucosal (mucous membranes) melanoma. The study will measure how long patients live without their cancer getting worse (progression-free survival) over up to 5 years. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 99 participants. Participants will be randomly assigned to one of three groups to receive immunotherapy at different times of day.
What's involved
You would receive nivolumab and ipilimumab intravenously (through a vein) every three weeks for four cycles, followed by maintenance nivolumab for up to two years. You would also undergo biopsies, blood and swab collections, CT scans, MRI scans, and wear an actigraphy device.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be assessed for up to 5 years after randomization.

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NCT07155317

Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial

Recruiting
PHASE2Ages 18+InterventionalTreatment
Emory University
~99 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyIpilimumabMagnetic Resonance ImagingMedical Device Usage and Evaluation

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) A versus (vs.) C and B vs. C
Measured over From randomization to progression or death, assessed up to 5 years

Conditions

Advanced Acral Melanoma
Advanced Cutaneous Melanoma
Advanced Mucosal Melanoma
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Acral Melanoma
Metastatic Cutaneous Melanoma
Metastatic Mucosal Melanoma
Unresectable Acral Melanoma
Unresectable Cutaneous Melanoma
Unresectable Mucosal Melanoma

Explore related trials

Acral MelanomaCutaneous MelanomaMelanomaMucosal Melanoma

Where it's being run

2 sites across 1 states
Georgia2

Study leadership

  • Michael Lowe, MD, MA · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Michael C. Lowe, MD, MA
[email protected]
404-778-0680
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pathologically confirmed American Joint Committee on Cancer (AJCC) 8th edition stage IV unresectable cutaneous, acral, or mucosal melanoma
No uveal melanoma
Patients with asymptomatic, non-hemorrhagic brain metastases \< 2 cm are eligible
No prior immunotherapy within 1 year, (serine/threonine-protein kinase B-raf \[BRAF\]/mitogen-activated protein kinase \[MEK\] inhibitors allowed)
Eastern Cooperative Oncology Group (ECOG) 0-1
Age ≥ 18
Adequate organ function to receive ipilimumab/nivolumab

Exclusion

Immunosuppression (\> 10mg prednisone daily)
Active autoimmune disease that would preclude the administration of immunotherapy
Active leptomeningeal disease

What this trial measures

  • Progression-Free Survival (PFS) A versus (vs.) C and B vs. CFrom randomization to progression or death, assessed up to 5 years

    Will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be compared between arms with a log rank test. The hazard ratio and the corresponding 95% confidence interval (CI) for the A vs. C and B vs. C comparisons will be estimated in a Cox proportional hazards model using the randomized arm as a single covariate. The PFS curves for each randomized arm will be estimated using the Kaplan-Meier (KM) method. In addition, PFS rates at specific time points will be estimated using KM estimates on the PFS curve for each randomized arm. Associated 2-sided 95% CIs will be calculated using the Greenwood formula (using log-log transformation).