MELCHRONO: A Prospective Randomized Study Investigating Chrono-immunotherapy for Advanced Melanoma.

Sponsor
Swiss Cancer Institute
Study ID
NCT07574047
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

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

Interventions

  • Immune Checkpoint Inhibitors — DRUG
    Morning administration of ICI per physician's choice, according to local practice: Nivolumab (Opdivo®) Monotherapy - 240 mg administered intravenously every 2 weeks (Q2W) Pembrolizumab (Keytruda®) Monotherapy \- 200 mg administered intravenously every 3 weeks (Q3W) Ipilimumab (Yervoy®) + Nivolumab (Opdivo®) Combination Therapy * Induction Phase: * Ipilimumab 3 mg/kg intravenously every 3 weeks (Q3W) * Nivolumab 1 mg/kg intravenously every 3 weeks (Q3W) * Administered for 4 cycles * Maintenance Phase: * Nivolumab 240 mg administered intravenously every 2 weeks (Q2W) Nivolumab + Relatlimab Fixed-Dose Combination (Opdualag®) Nivolumab 480 mg and relatlimab 160 mg administered intravenously every 4 weeks (Q4W)
  • Immune Checkpoint Inhibitors — DRUG
    Afternooon administration of ICI per physician's choice, according to local practice: Nivolumab (Opdivo®) Monotherapy - 240 mg administered intravenously every 2 weeks (Q2W) Pembrolizumab (Keytruda®) Monotherapy \- 200 mg administered intravenously every 3 weeks (Q3W) Ipilimumab (Yervoy®) + Nivolumab (Opdivo®) Combination Therapy * Induction Phase: * Ipilimumab 3 mg/kg intravenously every 3 weeks (Q3W) * Nivolumab 1 mg/kg intravenously every 3 weeks (Q3W) * Administered for 4 cycles * Maintenance Phase: * Nivolumab 240 mg administered intravenously every 2 weeks (Q2W) Nivolumab + Relatlimab Fixed-Dose Combination (Opdualag®) Nivolumab 480 mg and relatlimab 160 mg administered intravenously every 4 weeks (Q4W)

Study Details

Melanoma remains a common cancer with rising incidence, and despite significant improvements with immune checkpoint inhibitors (ICIs), clinical outcomes remain heterogeneous. Retrospective analyses across multiple tumor types, including melanoma, suggest that earlier daytime administration of ICIs may enhance therapeutic effectiveness, potentially due to circadian modulation of immune function. A pronounced survival benefit has been observed particularly among female patients receiving earlier infusions. This trial prospectively evaluates whether aligning ICI administration with circadian immune activity can improve outcomes in melanoma and support the development of sex-specific optimization of immunotherapy.

Key Dates

First listed
May 7, 2026
Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2032

Study Design

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

Arms

  • Experimental: ICI Infusions 8-12 h
    Participants will be randomized 1:1 to receive standard-of-care ICI therapy in an early (08:00 - 12:00) infusion time window.
  • Active Comparator: ICI Infusions 15-18 h
    Participants will be randomized 1:1 to receive standard-of-care ICI therapy in a late (15:00 - 18:00) infusion time window.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From randomization to Progressive Desease or death, up to 6 years ]

Central Contacts

Find similar trials

Nationwide
Melanoma trialsOncology trialsSkin cancer trialsDermatology trials

Related Studies