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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07155317
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Acral Melanoma
  • Advanced Cutaneous Melanoma
  • Advanced Mucosal Melanoma
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Acral Melanoma
  • Metastatic Cutaneous Melanoma
  • Metastatic Mucosal Melanoma
  • Unresectable Acral Melanoma
  • Unresectable Cutaneous Melanoma
  • Unresectable Mucosal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo check swab and blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Medical Device Usage and Evaluation — OTHER
    Wear an actigraphy device
  • Nivolumab — BIOLOGICAL
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Oct 29, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Progression-Free Survival (PFS) A versus (vs.) C and B vs. C [ Time Frame: From randomization to progression or death, assessed up to 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Tiffaney Roundtree
[email protected]
Michael C. Lowe, MD, MA (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Tiffaney Roundtree
[email protected]
Michael C. Lowe, MD, MA (PRINCIPAL_INVESTIGATOR)

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