🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 2Ages 18 Years - anyAllEmory University
NCT07155317 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Ipilimumab
  • Magnetic Resonance Imaging
📍

Where

2 sites
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Emory Saint Joseph's Hospital
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy