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NCT03757689 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant PD-1 Blockade in Patients with Stage IIB/C Melanoma
A Phase 2 study of Melanoma, sponsored by Abramson Cancer Center at Penn Medicine.
- Active
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 3
- Study locations
NCT03757689 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 63 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03757689, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by Abramson Cancer Center at Penn Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 3
- Study locations
Study Summary
The main purpose of this study is to determine the rate of positive sentinel lymph nodes (i.e. the closest draining lymph node(s) to the primary melanoma site) and to test whether treatment with pembrolizumab before surgery to remove melanoma reduces the rate of positive sentinel lymph nodes in patients with Stage IIB/C melanoma. Subjects with stage II melanoma will receive one dose of pembrolizumab 200 mg, then undergo standard definitive surgery with wide excision and sentinel lymph node (SLN) biopsy approximately 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of adjuvant pembrolizumab 200 mg every 3 weeks.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- PROCEDURE Wide Excision and Sentinel Lymph Node (SLN) Biopsy
Study Locations (3)
Kentucky
- University of Louisville - Louisville
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-05-06 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03757689
The ClinicalTrials.gov registry entry for NCT03757689 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (91% lower). The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03757689 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Kentucky, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT03757689 about?
NCT03757689 is a clinical study titled "Neoadjuvant PD-1 Blockade in Patients with Stage IIB/C Melanoma". The main purpose of this study is to determine the rate of positive sentinel lymph nodes (i.e. the closest draining lymph node(s) to the primary melanoma site) and to test whether treatment with pembrolizumab before surgery to remove melanoma reduces the rate of positive sentinel lymph nodes in pati...
What is the current status of trial NCT03757689?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2019-05-06. Estimated completion is 2027-02.
What conditions does trial NCT03757689 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT03757689?
The interventions under investigation include: Pembrolizumab (DRUG), Wide Excision and Sentinel Lymph Node (SLN) Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03757689?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03757689 being conducted?
This trial has 3 study locations across Kentucky, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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