CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT04633278. 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 Multicenter, Phase 2, Open-label Study of Intratumoral CMP-001 in Combination With Intravenous Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to: * To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC * To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC * To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached.
Study identification
- NCT ID
- NCT04633278
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 24 participants
Conditions and interventions
Conditions
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
- Jan 20, 2021
- Primary completion
- Jan 18, 2024
- Completion
- Jan 18, 2024
- Last update posted
- May 10, 2025
2021 – 2024
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| University of California - San Diego | La Jolla | California | 92093 | — |
| University of Southern California - Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UCLA Hematology-Oncology | Los Angeles | California | 90095 | — |
| University of Southern California: Norris Oncology/Hematology - Newport Beach | Newport Beach | California | 92663 | — |
| University Cancer & Blood Center | Athens | Georgia | 30607 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Atlantic Health | Morristown | New Jersey | 07960 | — |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Bon Secours St. Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| University of Tennessee | Knoxville | Tennessee | 37920 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Houston Methodist Hospital/Cancer Center | Houston | Texas | 77030 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
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 NCT04633278, 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 May 10, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04633278 live on ClinicalTrials.gov.