Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial
NCT ID: NCT07155317
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
99 participants
INTERVENTIONAL
2025-10-29
2027-12-31
Brief Summary
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Detailed Description
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I. To compare the progression-free survival (PFS) following administration of immunotherapy at different time-of-day intervals for previously untreated unresectable or metastatic melanoma.
SECONDARY OBJECTIVES:
I. To compare adverse events (AEs). II. Rate of receiving all immunotherapy doses as scheduled. III. Objective response rate. IV. Melanoma specific survival (MSS) and overall survival (OS). V. Patient-reported quality of life (QOL).
TERTIARY/EXPLORATORY OBJECTIVE:
I. To explore immune biomarkers associated with clinical efficacy (PFS, OS).
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes at 0800-1100 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, computed tomography (CT) or magnetic resonance imaging (MRI) and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.
ARM II: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 1100-1400 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.
ARM III: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 1400-1700 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.
After completion of study treatment, patients are followed up every 3 months for 12 months, then for up to year 5.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (nivolumab, ipilimumab)
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 0800-1100 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.
Biopsy Procedure
Undergo tumor tissue biopsy
Biospecimen Collection
Undergo check swab and blood sample collection
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Medical Device Usage and Evaluation
Wear an actigraphy device
Nivolumab
Given IV
Questionnaire Administration
Ancillary studies
Arm II (nivolumab, ipilimumab)
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 1100-1400 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.
Biopsy Procedure
Undergo tumor tissue biopsy
Biospecimen Collection
Undergo check swab and blood sample collection
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Medical Device Usage and Evaluation
Wear an actigraphy device
Nivolumab
Given IV
Questionnaire Administration
Ancillary studies
Arm III (nivolumab, ipilimumab)
Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes at 1400-1700 on day 1 of each cycle. Cycles repeat every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance nivolumab for up to a total of 2 years. Patients wear an actigraphy device for 5-7 days at enrollment prior to first infusion and for up to 4 weeks then over 3 weeks starting with visit 4. Patients also undergo check swab and blood sample collection, CT or MRI and MRI or CT of brain throughout the study. Additionally, patients may optionally undergo tumor tissue biopsy throughout the study.
Biopsy Procedure
Undergo tumor tissue biopsy
Biospecimen Collection
Undergo check swab and blood sample collection
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Medical Device Usage and Evaluation
Wear an actigraphy device
Nivolumab
Given IV
Questionnaire Administration
Ancillary studies
Interventions
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Biopsy Procedure
Undergo tumor tissue biopsy
Biospecimen Collection
Undergo check swab and blood sample collection
Computed Tomography
Undergo CT
Ipilimumab
Given IV
Magnetic Resonance Imaging
Undergo MRI
Medical Device Usage and Evaluation
Wear an actigraphy device
Nivolumab
Given IV
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active autoimmune disease that would preclude the administration of immunotherapy
* Active leptomeningeal disease
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Michael Lowe
Principal Investigator
Principal Investigators
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Michael Lowe, MD, MA
Role: PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Tiffaney Roundtree
Role: primary
Tiffaney Roundtree
Role: primary
Other Identifiers
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NCI-2025-03025
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00008806
Identifier Type: OTHER
Identifier Source: secondary_id
WINSHIP6451-24
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00008806
Identifier Type: -
Identifier Source: org_study_id