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NCT04949113 · ClinicalTrials.gov registry record · Phase 3
Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma
A Phase 3 study of Malignant Melanoma Stage III, sponsored by The Netherlands Cancer Institute.
- Active
- Registry status
- Phase 3
- Development phase
- 423
- Enrollment target
- 20
- Study locations
NCT04949113: Active Phase 3 study of Malignant Melanoma Stage III, sponsored by The Netherlands Cancer Institute.
NCT04949113 is a Phase 3 study of Malignant Melanoma Stage III that is active but no longer recruiting, run by The Netherlands Cancer Institute. The registered enrollment target is 423 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04949113, a Phase 3 study of Malignant Melanoma Stage III, is active but no longer recruiting, sponsored by The Netherlands Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 423 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
EFS is defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, treatment-related death, or melanoma-related death, whichever occurs first. Occurrence of a new primary melanoma during treatment/follow-up is also regarded as an event. Presurgical resectable progression to stage III disease in arm A is not defined as an event, even as death to another reason than melanoma or the study treatment.
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 |
What the registry record for NCT04949113 still lists
NCT04949113 is an interventional study that assigns participants to a tested intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
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.
NCT04949113 names 20 study sites across 5 states, led by Other, California, Texas.
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.
What interventions are being tested in trial NCT04949113?
The interventions under investigation include: Neoadjuvant ipilimumab + nivolumab (DRUG), Adjuvant nivolumab (DRUG).
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.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04949113's enrollment target sits among peer trials
423 886th of 2000 higher than 1,115 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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