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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: Completed Phase 2 study of Oropharynx Cancer and HNSCC, sponsored by University of California, San Diego.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of patients with partial or complete response in tumor burden as defined by RECIST
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 |
What the finished NCT03082534 record still lists
NCT03082534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 129-participant average among 26 other Oropharynx Cancer trials with a reported enrollment target (40% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03082534's enrollment target sits among peer trials
78 8th of 26 higher than 19 of 26 other Oropharynx Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oropharynx Cancer 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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