Timing of Immunotherapy in Melanoma

Sponsor
Radboud University Medical Center
Study ID
NCT07696715
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Timing of first administration (early morning) — OTHER
    The timing of the first administration of combination immunotherapy starting before 10am
  • Timing of immunotherapy (afternoon) — OTHER
    The timing of the first administration of combination immunotherapy starting after 1pm

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2033

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: A: early morning immunotherapy
    Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting before 10am
  • Active Comparator: B: afternoon immunotherapy
    Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting after 1pm

Primary Outcome Measure

Best overall response rate [ Time Frame: from enrollment to 1year ]

Central Contacts

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