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Timing of Immunotherapy in Melanoma

NCT07696715 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-08-13

No results posted yet for this study

Summary

The TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data from the randomized clinical trial will be combined with observational data.

Conditions

Interventions

OTHER

Timing of first administration (early morning)

The timing of the first administration of combination immunotherapy starting before 10am

OTHER

Timing of immunotherapy (afternoon)

The timing of the first administration of combination immunotherapy starting after 1pm

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2029-09-30
Completion
2033-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696715 on ClinicalTrials.gov