A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Public ClinicalTrials.gov record NCT06385080. 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 Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Study identification
- NCT ID
- NCT06385080
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 287 participants
Conditions and interventions
Conditions
Interventions
- Amivantamab Biological
- Pembrolizumab Biological
- Paclitaxel Drug
- Carboplatin Drug
Biological · Drug
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
- Apr 21, 2024
- Primary completion
- Dec 26, 2032
- Completion
- Jul 27, 2033
- Last update posted
- Aug 27, 2026
2024 – 2033
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Diego Moores Cancer Center | La Jolla | California | 92093 | Completed |
| University of Colorado Denver Anschultz Medical Campus | Aurora | Colorado | 80045 | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | 06520 | Recruiting |
| The University of Chicago Medical Center (UCMC) | Chicago | Illinois | 60637 | Recruiting |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 2013 | Recruiting |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22903 | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06385080, 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 Aug 27, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06385080 live on ClinicalTrials.gov.