Study on Timing of Immunotherapy for Advanced Melanoma: The TIME Trial

Program Overview

The purpose of this study is to find out if giving the immunotherapy drugs ipilimumab and nivolumab at different times of the day can improve treatment outcomes for patients with advanced melanoma. These drugs help the immune system attack cancer cells, but not all patients benefit from them. Researchers want to see if administering these drugs earlier in the day can lead to better responses and longer survival for patients with stage IV or inoperable melanoma.

Description

The main goal of this study is to compare how long patients live without their melanoma getting worse when they receive immunotherapy at different times of the day. Researchers will also look at side effects, how many patients complete all their scheduled treatments, and overall survival rates. Patients will be randomly assigned to one of three groups, each receiving treatment at different times:

• Group 1: Receives nivolumab and ipilimumab in the morning (8:00-11:00 AM).
• Group 2: Receives nivolumab and ipilimumab around midday (11:00 AM-2:00 PM).
• Group 3: Receives nivolumab and ipilimumab in the afternoon (2:00-5:00 PM).

Each group will receive these treatments every three weeks for four cycles, as long as the cancer does not progress and side effects are manageable. After the initial treatment, patients will continue to receive nivolumab alone for up to two years. Throughout the study, patients will wear a device to monitor activity, provide blood and cheek swab samples, and undergo regular scans. Optional tumor biopsies may also be performed. After treatment, patients will have follow-up visits every three months for the first year, and then annually for up to five years.

Eligibility Criteria

Locations