RecruitingPhase 2NCT07155317

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

The TIME Trial - Phase II Randomized Controlled Trial of Time-of-Day Specified Immunotherapy for Advanced Melanoma


Sponsor

Emory University

Enrollment

99 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether the time of day that immunotherapy is given affects how well it works for advanced melanoma. Researchers want to know if morning vs. evening dosing of the drugs ipilimumab and nivolumab makes a difference in outcomes. **You may be eligible if...** - You have been diagnosed with Stage IV melanoma of the skin, hands/feet, or mucous membranes that cannot be surgically removed - You are 18 or older - You have not received immunotherapy in the past year (targeted BRAF/MEK therapies are allowed) - You are in good physical condition (ECOG 0–1) - You have small, symptom-free brain tumors (less than 2 cm) — these are allowed **You may NOT be eligible if...** - You have eye (uveal) melanoma - You are taking high-dose steroids or other immune-suppressing medications (more than 10 mg prednisone daily) - You have an active autoimmune disease that would prevent immunotherapy - Cancer has spread to the membranes covering your brain (leptomeningeal disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo tumor tissue biopsy

PROCEDUREBiospecimen Collection

Undergo check swab and blood sample collection

PROCEDUREComputed Tomography

Undergo CT

BIOLOGICALIpilimumab

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERMedical Device Usage and Evaluation

Wear an actigraphy device

BIOLOGICALNivolumab

Given IV

OTHERQuestionnaire Administration

Ancillary studies


Locations(2)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT07155317


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