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NCT07155317 · ClinicalTrials.gov registry record · Phase 2
Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
A Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Cutaneous Melanoma, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 2
- Study locations
NCT07155317: Recruiting Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Cutaneous Melanoma, sponsored by Emory University.
NCT07155317 is a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Cutaneous Melanoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 99 participants, below the 149-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (34% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07155317, a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Cutaneous Melanoma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Ipilimumab
Study Locations (2)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2025-10-29 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT07155317 shows while recruiting
NCT07155317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 149-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (34% lower).
The record links to 10 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07155317 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT07155317 about?
NCT07155317 is a clinical study titled "Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial". 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 ipilimuma...
What is the current status of trial NCT07155317?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2025-10-29. Estimated completion is 2027-12-31.
What conditions does trial NCT07155317 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma, Metastatic Acral Melanoma, Unresectable Cutaneous Melanoma.
What interventions are being tested in trial NCT07155317?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07155317?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07155317 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07155317's enrollment target sits among peer trials
99 11th of 32 higher than 22 of 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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