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

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.

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Michael Lowe, MD, MA · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-29

Primary Completion

2026-12-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations