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Clinical Trial NCT07155317 for 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 is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Emory UniversityTime-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial Phase 2 99 Immunotherapy Vaccine Study
Clinical Trial NCT07155317 is designed to study Treatment for 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. It is a Phase 2 interventional study that is recruiting, having started on October 29, 2025, with plans to enroll 99 participants. Led by Emory University, it is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on November 12, 2025.
Brief 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...Show More
Detailed Description
PRIMARY OBJECTIVE:
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...
Show MoreOfficial Title
The TIME Trial - Phase II Randomized Controlled Trial of Time-of-Day Specified Immunotherapy for Advanced Melanoma
Conditions
Advanced Acral MelanomaAdvanced Cutaneous MelanomaAdvanced Mucosal MelanomaClinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Acral MelanomaMetastatic Cutaneous MelanomaMetastatic Mucosal MelanomaUnresectable Acral MelanomaUnresectable Cutaneous MelanomaUnresectable Mucosal MelanomaOther Study IDs
- STUDY00008806
- NCI-2025-03025 (Registry Identifier) (CTRP (Clinical Trial Reporting Program))
- STUDY00008806 (Other Identifier) (Emory University Hospital/Winship Cancer Institute)
- WINSHIP6451-24 (Other Identifier) (Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (U.S. NIH Grant/Contract)
NCT ID Number
Start Date (Actual)
2025-10-29
Last Update Posted
2025-11-12
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
99
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 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 week...Show More | 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 |
ExperimentalArm 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 week...Show More | 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 |
Active ComparatorArm 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 week...Show More | 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression-Free Survival (PFS) A versus (vs.) C and B vs. C | Will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be compared between arms with a log rank test. The hazard ratio and the corresponding 95% confidence interval (CI) for the A vs. C and B vs. C comparisons will be estimated in a Cox proportional hazards model using the randomized arm as a single covariate. The PFS curves for each randomized arm will be estimated using the Kaplan-Meier (KM) method. In addition, PFS rates at specific time points will be estimated using KM estimates on the PFS curve for each randomized arm. Associated 2-sided 95% CIs will be calculated using the Greenwood formula (using log-log transformation). | From randomization to progression or death, assessed up to 5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of Treatment-Related Adverse Events (AE) | Will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Frequencies and percentages will be used to summarize safety events. All treatment-associated AE event rates, as well as treatment-associated grade 3 or higher AE event rates will be reported. Event rates will be compared between arms using a Chi-square test. Differences in event rates will be reported, and 95% CIs will be estimated. | Up to 100 days after last dose of study treatment |
Objective Response Rate (ORR) | Will be defined as complete response and/or partial response assessed using RECIST 1.1 criteria. Will be estimated as a proportion, with an exact 95% CI estimated using the Clopper-Pearson method. ORR will be compared between arms using a Chi-square test. | Up to 3 months |
Overall Survival (OS) | Will be compared between arms with a log rank test. The hazard ratio and the corresponding 95% CIs for the A vs. C and B vs. C comparisons will be estimated in a Cox proportional hazards model using the randomized arm as a single covariate. The OS curves for each randomized arm will be estimated using the KM method. In addition, OS rates at specific time points will be estimated using KM estimates on the OS curve for each randomized arm. Associated 2-sided 95% CIs will be calculated using the Greenwood formula (using log-log transformation). | From randomization to death from any cause, assessed up to 5 years |
PFS A vs. B | Will be determined using RECIST 1.1. PFS will be compared between arms with a log rank test. The hazard ratio and the corresponding 95% CI for the A vs. B comparison will be estimated in a Cox proportional hazards model using the randomized arm as a single covariate. The PFS curves for each randomized arm will be estimated using the KM method. In addition, PFS rates at specific time points will be estimated using KM estimates on the PFS curve for each randomized arm. Associated 2-sided 95% CIs will be calculated using the Greenwood formula (using log-log transformation). | From randomization to progression or death, assessed up to 5 years |
Disease Specific Survival | To explore immune biomarkers associated with clinical efficacy from the pre-treatment and post-treatment melanoma biopsy specimens and peripheral blood. | Up to 5 years |
Rate of Receiving all Immunotherapy Doses as Scheduled | To compare rate of receiving all immunotherapy doses as scheduled, of subjects with previously untreated unresectable or metasatic melanoma who receive immunotherapy infusions at different time-of-day intervals, and impact of quality of life on timing of infusion. | Up to 4 cycles (cycle length = 3 weeks) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
Emory UniversityNational Cancer Institute (NCI)3019 active studies to exploreStudy Responsible Party
Michael Lowe, Principal Investigator, Principal Investigator, Emory University
Study Central Contact
Contact: Michael C. Lowe, MD, MA, 404-778-0680, [email protected]
Contact: Zachary Buchwald, MD, PhD, [email protected]
2 Study Locations in 1 Countries
Georgia
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States
Tiffaney Roundtree, Contact, [email protected]
Michael C. Lowe, MD, MA, Principal Investigator
Recruiting
Emory Saint Joseph's Hospital, Atlanta, Georgia, 30342, United States
Tiffaney Roundtree, Contact, [email protected]
Michael C. Lowe, MD, MA, Principal Investigator
Not yet recruiting