Actively Recruiting
Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
Led by Emory University · Updated on 2025-11-12
99
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Pathologically confirmed AJCC 8th edition stage IV unresectable cutaneous, acral, or mucosal melanoma
- Patients with asymptomatic, non-hemorrhagic brain metastases smaller than 2 cm are eligible
- No prior immunotherapy within 1 year (BRAF/MEK inhibitors allowed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function to receive ipilimumab and nivolumab
You will not qualify if you...
- Current immunosuppression with more than 10 mg prednisone daily
- Active autoimmune disease that would prevent immunotherapy treatment
- Presence of active leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Not Yet Recruiting
Research Team
M
Michael C. Lowe, MD, MA
CONTACT
Z
Zachary Buchwald, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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