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Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma
NCT04949113 · View on ClinicalTrials.gov ↗
Study Summary
This is an international (Australia, Europe, and USA) open-label two-arm randomized phase 3 trial including 420 stage III (≤3 resectable in-transit metastases allowed) cutaneous or unknown primary melanoma patients. Patients will be randomized 1:1 to receive either 2 cycles of neoadjuvant ipilimumab 80 mg + nivolumab 240 mg every 3 weeks followed by a total lymph node dissection (TLND) and, if applicable, resection of in-transit metastases (arm A) versus standard upfront TLND +/- resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks (arm B). Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks for 46 weeks (11 cycles). In case of BRAF V600E/K mutation-positivity, patients from arm A with a pathologic partial or non-response (\>10% viable tumor) will be treated with adjuvant dabrafenib plus trametinib for 46 weeks. Patients will be treated in the study in both arms until melanoma progression to irresectable stage III or stage IV disease, disease recurrence, unacceptable toxicity, subject withdrawal of consent or until end of study treatment. An interim analysis will be performed after 60 events have occurred. The data safety monitory board (DSMB) will be ad hoc consulted when unexpected toxicities are reported. Patients will be followed by 12 weekly CT scans until end of year 3 and then until year 5 according to the institute's standards.
Conditions Studied
Interventions
- DRUG Neoadjuvant ipilimumab + nivolumab
- DRUG Adjuvant nivolumab
Study Locations (20)
Other
- Princess Alexandra Hospital — Brisbane
- Lake Macquarie Private Hospital — Gateshead
- Alfred Health — Melbourne
- Peter MacCallum Cancer Center — Melbourne
- Fiona Stanley Hospital — Murdoch
- Tasman Oncology — Southport
- Westmead Hospital — Sydney
- Amsterdam University Medical Center - location VUmc — Amsterdam
- Amphia Ziekenhuis — Breda
- Maxima Medisch Centrum — Eindhoven
- Medisch Spectrum Twente — Enschede
- University Medical Center Groningen — Groningen
- Zuyderland Medisch Centrum — Heerlen
- Medisch Centrum Leeuwarden — Leeuwarden
- Leiden University Medical Center — Leiden
- Maastricht University Medical Center — Maastricht
California
- The Angeles Clinic — Los Angeles
Texas
- MD Anderson Cancer Center — Houston
New South Wales
- Melanoma Institute Australia (MIA) — Sydney
North Holland
- Netherlands Cancer Institute — Amsterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2028-12-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04949113
The ClinicalTrials.gov registry entry for NCT04949113 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 423 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Netherlands Cancer Institute, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Malignant Melanoma Stage III appearing as the primary indexed condition, and to 2 interventions — of which Neoadjuvant ipilimumab + nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04949113 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04949113 about?
NCT04949113 is a clinical study titled "Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma". This is an international (Australia, Europe, and USA) open-label two-arm randomized phase 3 trial including 420 stage III (≤3 resectable in-transit metastases allowed) cutaneous or unknown primary melanoma patients. Patients will be randomized 1:1 to receive either 2 cycles of neoadjuvant ipilimumab...
What is the current status of trial NCT04949113?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 423 participants. The study started on 2021-07-08. Estimated completion is 2028-12-19.
What conditions does trial NCT04949113 study?
This clinical trial studies the following conditions: Malignant Melanoma Stage III. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04949113?
The interventions under investigation include: Neoadjuvant ipilimumab + nivolumab (DRUG), Adjuvant nivolumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04949113?
This trial is sponsored by The Netherlands Cancer Institute, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04949113 being conducted?
This trial has 20 study locations across California, Texas, New South Wales, North Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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