MelanomaTIME-NLNCT07696715
Timing of Immunotherapy in Melanoma
A study testing Timing of first administration (early morning) and Timing of immunotherapy (afternoon) in people with Melanoma, run by Radboud University Medical Center at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Timing of first administration (early morning) and Timing of immunotherapy (afternoon)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesNetherlands
- Study dates
- 10 Aug 2026to 30 Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease.
- At least 18 years of age.
- World Health Organization (WHO) Performance Status 0-1.
- Measurable disease according to RECIST 1.1.
- Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment.
- Signed informed consent form
Who cannot join
- Uveal or mucosal melanoma (unknown primary melanoma is allowed).
- Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.
- Use of adrenal replacement medications, e.g. hydrocortisone.
- Use of melatonin agonists.
- Prior systemic therapy for irresectable/metastatic melanoma (prior T-VEC is allowed)
- Prior systemic therapy for resectable melanoma in the last 6 months (neo-adjuvant and adjuvant treatment is allowed if at least 6 months ago).
- Use of investigational drugs.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mirte Meijerink contact
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Not yet recruiting
Amsterdam UMC
Amsterdam
Fons van den Eertwegh
- Not yet recruiting
Antoni van Leeuwenhoek
Amsterdam
Hans van Thienen
- Not yet recruiting
Leiden UMC
Leiden
Ellen Kapiteijn
- Recruiting
Radboudumc
Nijmegen
Kalijn Bol, MD/PhD, +31243618800, kalijn.bol@radboudumc.nl
Mirte Meijerink, studies.onco@radboudumc.nl
- Not yet recruiting
ErasmusMC
Rotterdam
Astrid van der Veldt
About this study
Official title: Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm
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
- Melanoma
- Being tested
- Timing of first administration (early morning), Timing of immunotherapy (afternoon)
- Keywords
- melanoma, chronoimmunotherapy, timing
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| A: early morning immunotherapy | Active comparator | Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting before 10am Receives: Other: Timing of first administration (early morning) |
| B: afternoon immunotherapy | Active comparator | Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting after 1pm Receives: Other: Timing of immunotherapy (afternoon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response rate
Best overall response rate (radiological complete or partial response according to RECIST 1.1)
Measured: from enrollment to 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start10 Aug 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696715
- Sponsor's protocol ID
- R0128980
- Other IDs
- NL-011107
- Acronym
- TIME-NL
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm
- ClinicalTrials.gov ID
- NCT07696715
- Acronym / sponsor ID
- TIME-NL / R0128980
- Conditions
- Melanoma
- Keywords
- melanoma, chronoimmunotherapy, timing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: early morning immunotherapy | Active comparator | Other: Timing of first administration (early morning)Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting before 10am |
| B: afternoon immunotherapy | Active comparator | Other: Timing of immunotherapy (afternoon)Standard-of-care immune checkpoint inhibition with ipilimumab + nivolumab with the first administration starting after 1pm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease.
- At least 18 years of age.
- World Health Organization (WHO) Performance Status 0-1.
- Measurable disease according to RECIST 1.1.
- Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment.
Key exclusion criteria (7 listed)
- Uveal or mucosal melanoma (unknown primary melanoma is allowed).
- Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.
- Use of adrenal replacement medications, e.g. hydrocortisone.
- Use of melatonin agonists.
- Prior systemic therapy for irresectable/metastatic melanoma (prior T-VEC is allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of first administration (early morning)The timing of the first administration of combination immunotherapy starting before 10am | Other | A: early morning immunotherapy |
| Timing of immunotherapy (afternoon)The timing of the first administration of combination immunotherapy starting after 1pm | Other | B: afternoon immunotherapy |
Primary outcome
Best overall response rate
Time frame: from enrollment to 1year
Best overall response rate (radiological complete or partial response according to RECIST 1.1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirte Meijerink contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of first administration (early morning) and Timing of immunotherapy (afternoon) in people with Melanoma, run by Radboud University Medical Center at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kalijn Bol, MD/PhD (+31243618800, kalijn.bol@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best overall response rate (time frame: from enrollment to 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.