Time-of-day immunotherapy for advanced melanoma
Official title: The TIME Trial - Phase II Randomized Controlled Trial of Time-of-Day Specified Immunotherapy for Advanced Melanoma
Run by Emory University · NCT07155317 · Data updated 2026-11-12
This trial tests whether giving the immune drugs ipilimumab and nivolumab in the morning rather than later in the day helps people with unresectable or metastatic melanoma respond better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 99 (estimated) |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | ipilimumab, nivolumab, immunotherapy, prednisone |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | October 29, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | November 12, 2025 |
| Trial ID | NCT07155317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with pathologically confirmed AJCC v8 stage IV unresectable cutaneous, acral, or mucosal melanoma, ECOG 0-1, no prior immunotherapy within one year, and adequate organ function are ideal candidates.
✕Probably not a fit
Patients with uveal melanoma, active autoimmune disease that precludes immunotherapy, those on significant immunosuppression (>10 mg prednisone daily), or with active leptomeningeal disease are excluded and would not receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with unresectable or metastatic cutaneous, acral, or mucosal melanoma are randomized to one of three specified infusion time windows and receive combination ipilimumab plus nivolumab for four 3-week cycles followed by maintenance nivolumab for up to two years. The primary endpoint is progression-free survival, with secondary endpoints including adverse events, completion of scheduled doses, objective response rate, melanoma-specific and overall survival, and patient-reported quality of life. Participants wear actigraphy devices, provide blood and swab samples, and may opt into tumor biopsies to explore immune biomarkers associated with outcomes. Regular CT or MRI (including brain imaging) is used to monitor disease throughout the study.
Why it matters
Potential benefit: If successful, scheduling immunotherapy earlier in the day could improve progression-free survival and overall outcomes for patients with advanced melanoma.
How similar studies have gone: Some prior studies have shown time-of-day effects for vaccines and other therapies, but timing effects for immune checkpoint inhibitors like ipilimumab and nivolumab remain largely untested in melanoma.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Immunosuppression (\> 10mg prednisone daily) * Active autoimmune disease that would preclude the administration of immunotherapy * Active leptomeningeal disease
Where it's running
-
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States Recruiting -
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States Not yet recruiting
Study contacts
- Principal investigator: Michael Lowe, MD, MA — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Michael C. Lowe, MD, MA
- Email: mlowe3@emory.edu
- Phone: 404-778-0680
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.