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NCT03082534 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
A Phase 2 study of Oropharynx Cancer and HNSCC, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 4
- Study locations
NCT03082534 is a Phase 2 study of Oropharynx Cancer and HNSCC that has completed, run by University of California, San Diego. The registered enrollment target is 78 participants, below the 129-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (40% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT03082534, a Phase 2 study of Oropharynx Cancer and HNSCC, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1 inhibitor-naïve, cetuximab-naïve arm (Cohort 1), a PD-1/PD-L1 inhibitor-refractory, cetuximab-naïve arm (Cohort 2), a PD-1/PD-L1 inhibitor-refractory, cetuximab-refractory arm (Cohort 3), and a cutaneous HNSCC arm (Cohort 4). A total of 83 patients (33 in Cohort 1, 25 in Cohort 2, 15 in Cohort 3, and 10 in Cohort 4) will be eligible to enroll. Patients will be enrolled at 4 sites: UC San Diego Moores Cancer Center, UC Los Angeles Jonsson Comprehensive Cancer Center, University of Michigan Comprehensive Cancer Center, and University of Washington Siteman Cancer Center.
Conditions Studied
Interventions
- DRUG Pembrolizumab, Cetuximab
Study Locations (4)
California
- UCSD Moores Cancer Center - La Jolla
- University of California Los Angeles Cancer Center - Los Angeles
Michigan
- University of Michigan Cancer Center - Ann Arbor
Missouri
- Washington School of Medicine Cancer Center - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2017-03-28 |
| Est. Completion | 2025-09-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03082534
The ClinicalTrials.gov registry entry for NCT03082534 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (40% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Oropharynx Cancer appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab, Cetuximab is the first listed.
NCT03082534 reports 4 study locations spanning 3 distinct geographic areas - top geographies include California, Michigan, Missouri.
Frequently Asked Questions
What is clinical trial NCT03082534 about?
NCT03082534 is a clinical study titled "Pembrolizumab Combined With Cetuximab for Treatment of Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma". This is a prospective, multi-center, open-label, non-randomized, multi-arm phase II trial to evaluate the efficacy of combination therapy with pembrolizumab and cetuximab for patients with recurrent/metastatic HNSCC. There will be four patient cohorts, including a PD-1/PD-L1 inhibitor-naïve, cetuxim...
What is the current status of trial NCT03082534?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2017-03-28. Estimated completion is 2025-09-11.
What conditions does trial NCT03082534 study?
This clinical trial studies the following conditions: Oropharynx Cancer, HNSCC, Head and Neck Neoplasms, Cutaneous Squamous Cell Carcinoma, Oral Cavity Cancer.
What interventions are being tested in trial NCT03082534?
The interventions under investigation include: Pembrolizumab, Cetuximab (DRUG).
Who is sponsoring clinical trial NCT03082534?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03082534 being conducted?
This trial has 4 study locations across California, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.