Status:
RECRUITING
Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Acral Melanoma
Advanced Cutaneous Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 cann...
Detailed Description
PRIMARY OBJECTIVE: I. To compare the progression-free survival (PFS) following administration of immunotherapy at different time-of-day intervals for previously untreated unresectable or metastatic m...
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
Key Trial Info
Start Date :
October 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT07155317
Start Date
October 29 2025
End Date
December 31 2027
Last Update
November 12 2025
Active Locations (2)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342