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NCT04462406 · ClinicalTrials.gov registry record · Phase 2
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
A Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Unresectable Melanoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT04462406 is a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Unresectable Melanoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 150 participants, roughly in line with the 147-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target. The trial reports 20 study locations across 5 states.
The verdict
NCT04462406, a Phase 2 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Unresectable Melanoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- OTHER Patient Observation
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Kaiser Permanente Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fremont - Fremont
- Fresno Cancer Center - Fresno
- Kaiser Permanente-Fresno - Fresno
- The Angeles Clinic and Research Institute - West Los Angeles Office - Los Angeles
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- CARTI Cancer Center - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-02-09 |
| Est. Completion | 2026-08-29 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04462406
The ClinicalTrials.gov registry entry for NCT04462406 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 147-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target. The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04462406 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT04462406 about?
NCT04462406 is a clinical study titled "Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial". This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable mela...
What is the current status of trial NCT04462406?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2021-02-09. Estimated completion is 2026-08-29.
What conditions does trial NCT04462406 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Advanced Melanoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT04462406?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Patient Observation (OTHER).
Who is sponsoring clinical trial NCT04462406?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04462406 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Clinical Stage IV Cutaneous Melanoma AJCC v8
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