Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial

Recruiting now · Phase 2

Conditions studied: Advanced Acral Melanoma, Advanced Cutaneous Melanoma, Advanced Mucosal Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Acral Melanoma, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma, Unresectable Acral Melanoma, Unresectable Cutaneous Melanoma, Unresectable Mucosal Melanoma

In brief

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.

Key facts

Study ID

NCT07155317

Run by

Emory University

People needed

99

Starts

2025-10-29

Expected to finish

2027-12-31

Last updated by the study team

2025-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Immunosuppression (> 10mg prednisone daily)
• Active autoimmune disease that would preclude the administration of immunotherapy
• Active leptomeningeal disease

Where it is running

• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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