OncoMatch/Clinical Trials/NCT07155317
Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
Is NCT07155317 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for advanced acral melanoma.
Treatment: Ipilimumab · Nivolumab — This phase II trial tests the safety and effectiveness of giving ipilimumab and nivolumab in the morning compared to other times of day in treating patients with melanoma that is stage IV or that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. While some patients have impressive outcomes with both of these drugs, over 40% of patients do not experience any clinical benefit. Studies have shown that the time of day that vaccines and other therapies are given have had an impact on response and survival. It is not known, however, whether time of day has an impact on response to immune checkpoint inhibitors, such as ipilimumab and nivolumab. Giving ipilimumab and nivolumab earlier in the day compared to later in the day may improve response to treatment and survival in patients with stage IV or unresectable melanoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy
Exception: immunotherapy > 1 year prior is allowed; BRAF/MEK inhibitors allowed
No prior immunotherapy within 1 year, (serine/threonine-protein kinase B-raf [BRAF]/mitogen-activated protein kinase [MEK] inhibitors allowed)
Lab requirements
Blood counts
adequate organ function to receive ipilimumab/nivolumab
Kidney function
adequate organ function to receive ipilimumab/nivolumab
Liver function
adequate organ function to receive ipilimumab/nivolumab
Adequate organ function to receive ipilimumab/nivolumab
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
- Emory Saint Joseph's Hospital · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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