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NCT04708418 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma
A Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT04708418: Active Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04708418 is a Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 240-participant average among 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04708418, a Phase 2 study of Clinical Stage III Cutaneous Melanoma AJCC v8 and Pathologic Stage IIIC 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
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). 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. Immunotherapy with CMP-001 may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. The addition of CMP-001 to pembrolizumab could improve the ability of the immune system to shrink tumors and to prevent them from returning.
Primary Outcome
Will be estimated by the percentage of patients who achieve complete response, partial response or stable disease by Response Evaluation Criteria in Solid Tumors (RECIST) and Immune-Modified RECIST criteria, with exact 90% confidence intervals.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- PROCEDURE Biopsy Procedure
Study Locations (20)
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Epic Care-Dublin - Dublin
- Bay Area Breast Surgeons Inc - Emeryville
- Epic Care Partners in Cancer Care - Emeryville
- Contra Costa Regional Medical Center - Martinez
- Alta Bates Summit Medical Center - Summit Campus - Oakland
- Bay Area Tumor Institute - Oakland
- Saint Joseph Hospital - Orange - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Alaska
- Anchorage Associates in Radiation Medicine - 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 University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04708418 still lists
NCT04708418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 240-participant average among 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (75% lower).
The record links to 6 conditions, with Clinical Stage III Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04708418 names 20 study sites across 4 states, led by California, Alaska, Arizona.
Frequently Asked Questions
What is clinical trial NCT04708418 about?
NCT04708418 is a clinical study titled "A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma". This phase II trial studies the effect of pembrolizumab alone or in combination with CMP-001 in treating patients with melanoma that can be treated by surgery (operable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may int...
What is the current status of trial NCT04708418?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-10-15. Estimated completion is 2026-06-30.
What conditions does trial NCT04708418 study?
This clinical trial studies the following conditions: Clinical Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Melanoma of Unknown Primary.
What interventions are being tested in trial NCT04708418?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT04708418?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04708418 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04708418's enrollment target sits among peer trials
60 14th of 23 higher than 10 of 23 other Clinical Stage III Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III 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.
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