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

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 ti

Trial Details

NCT ID

NCT07155317

Phase

PHASE2

Sponsor

Emory University

Status

RECRUITING

Cancer Type

Mucosal Melanoma Melanoma

Interventions

Biopsy Procedure
Biospecimen Collection
Computed Tomography
Ipilimumab
Magnetic Resonance Imaging
Medical Device Usage and Evaluation

Locations (sample)

Atlanta, Georgia, United States|33.749,-84.38798
Atlanta, Georgia, United States|33.749,-84.38798

Key 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)

For full eligibility, visit ClinicalTrials.gov.

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