NCT07155317 - Time-of-Day Specified Ipilimumab and Nivolumab for the Treatment of Stage IV Unresectable Melanoma, The TIME Trial | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 29, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

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 Melanoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo check swab and blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Medical Device Usage and Evaluation

Wear an actigraphy device

BIOLOGICAL

Nivolumab

Given IV

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (2)

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

Emory University

OTHER