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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-28)

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

๐ŸŸข Recruiting Phase 1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

๐Ÿฉบ Protocol Summary

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).

Primary Research Facility: University of California at San Diego Moores Cancer Center (La Jolla, California)

๐Ÿ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

๐Ÿ“ Primary Site Map

Site: University of California at San Diego Moores Cancer Center โ€” La Jolla, California

๐Ÿ“ All Participating Trial Locations (56 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. University of California at San Diego Moores Cancer Center โ€” La Jolla, California
2. University of Colorado Denver Anschultz Medical Campus โ€” Aurora, Colorado
3. Yale Cancer Center โ€” New Haven, Connecticut
4. The University of Chicago Medical Center (UCMC) โ€” Chicago, Illinois
5. University of Maryland School of Medicine โ€” Baltimore, Maryland
6. Dana Farber Cancer Institute โ€” Boston, Massachusetts
7. University of Michigan Rogel Cancer Center โ€” Ann Arbor, Michigan
8. Karmanos Cancer Institute โ€” Detroit, Michigan
9. Washington University School Of Medicine โ€” St Louis, Missouri
10. Rutgers Cancer Institute of New Jersey โ€” New Brunswick, New Jersey
11. University of North Carolina at Chapel Hill โ€” Chapel Hill, North Carolina
12. Cleveland Clinic โ€” Cleveland, Ohio
13. University of Utah Huntsman Cancer Institute โ€” Salt Lake City, Utah
14. University of Virginia โ€” Charlottesville, Virginia
15. Virginia Cancer Specialists โ€” Fairfax, Virginia
16. Beijing Cancer Hospital of Peking University โ€” United States
17. West China School of Medicine/West China Hospital, Sichuan University โ€” United States
18. Linyi Cancer Hospital โ€” United States
19. Fudan Cancer Hospital โ€” United States
20. Shanghai East Hospital โ€” United States
21. Union Hospital Tongji Medical College of Huazhong University of Science and Technology โ€” United States
22. Institut Sainte Catherine โ€” United States
23. Centre Oscar Lambret โ€” United States
24. CHU Nantes โ€” United States
25. Institut Curie โ€” United States

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๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06385080 โ€ข Last Synced: 2026-08-28
View on ClinicalTrials.gov โ†—
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