CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
Public ClinicalTrials.gov record NCT04695977. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label, Active-control, Phase 2/3 Study of First-line Intratumoral CMP-001 in Combination With Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects With Unresectable or Metastatic Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma. The secondary objectives of Phase 3 are to: * To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. * To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
Study identification
- NCT ID
- NCT04695977
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 20 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2021 (Actual)
- Primary completion
- Jul 22, 2024 (Actual)
- Completion
- Jul 22, 2024 (Actual)
- Last update posted
- Jun 15, 2026
2021 – 2024
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Moores Cancer Center at UC San Diego Health | La Jolla | California | 92093 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| USC Norris Oncology/Hematology-Newport Beach | Newport Beach | California | 92663 | — |
| California Cancer Associates for Research & Excellence, Inc. | San Marcos | California | 92069 | — |
| Hartford Healthcare | Hartford | Connecticut | 06106 | — |
| Cleveland Clinic | Weston | Florida | 33331 | — |
| University Cancer & Blood Center | Athens | Georgia | 30607 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| University of Louisville Health Care | Louisville | Kentucky | 40202 | — |
| Atlantic Health | Morristown | New Jersey | 07960 | — |
| Duke University Cancer Institute | Durham | North Carolina | 27710 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center / Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Texas Oncology, Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04695977, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04695977 live on ClinicalTrials.gov.