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NCT03698019 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
A Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 313
- Enrollment target
- 20
- Study locations
NCT03698019: Active Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT03698019 is a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 313 participants, above the 142-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03698019, a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 313 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.
Primary Outcome
Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Therapeutic Conventional Surgery
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Banner Boswell Medical Center - Sun City
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2019-02-15 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 2 |
What the registry record for NCT03698019 still lists
NCT03698019 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, above the 142-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (120% higher).
The record links to 4 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03698019 names 20 study sites across 4 states, led by Alaska, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03698019 about?
NCT03698019 is a clinical study titled "A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma". This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor ce...
What is the current status of trial NCT03698019?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 313 participants. The study started on 2019-02-15. Estimated completion is 2026-10-30.
What conditions does trial NCT03698019 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Mucosal Melanoma, Acral Lentiginous Melanoma.
What interventions are being tested in trial NCT03698019?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Therapeutic Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03698019?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03698019 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03698019's enrollment target sits among peer trials
313 4th of 32 higher than 29 of 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage IV Cutaneous Melanoma AJCC v8 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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