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New treatment option for Advanced Acral Melanoma
Official title Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
ClinicalTrials.gov ID: NCT07155317
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced acral melanoma.
Also referred to as Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join if
- Immunosuppression (\> 10mg prednisone daily)
- Active autoimmune disease that would preclude the administration of immunotherapy
- Active leptomeningeal disease
See the full eligibility 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
- Immunosuppression (\> 10mg prednisone daily)
- Active autoimmune disease that would preclude the administration of immunotherapy
- Active leptomeningeal disease
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.