A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer (NCT06385080)

🧪 Interventions in This Study

• Amivantamab (BIOLOGICAL)
• Pembrolizumab (BIOLOGICAL)
• Paclitaxel (DRUG)
• Carboplatin (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L/A) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease
2. Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1.
3. Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes \[any grade\], Grade less than or equal to \[\<=\]2 peripheral neuropathy and Grade \<=2 hypothyroidism stable on hormone replacement)
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
5. Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test. Participants should have: a) Hemoglobin \>=9 grams per deciliter (g/dL); b) Neutrophils \>=1.5 x 10\^3/mcg; c) Platelets \>=100 x 10\^3/mcg

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (56 Sites)

Showing the first 25 of 56 sites.

• University of California at San Diego Moores Cancer Center — La Jolla, California
• University of Colorado Denver Anschultz Medical Campus — Aurora, Colorado
• Yale Cancer Center — New Haven, Connecticut
• The University of Chicago Medical Center (UCMC) — Chicago, Illinois
• University of Maryland School of Medicine — Baltimore, Maryland
• Dana Farber Cancer Institute — Boston, Massachusetts
• University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
• Karmanos Cancer Institute — Detroit, Michigan
• Washington University School Of Medicine — St Louis, Missouri
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
• Cleveland Clinic — Cleveland, Ohio
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah
• University of Virginia — Charlottesville, Virginia
• Virginia Cancer Specialists — Fairfax, Virginia
• Beijing Cancer Hospital of Peking University — Beijing,
• West China School of Medicine/West China Hospital, Sichuan University — Cheng Du Shi,
• Linyi Cancer Hospital — Linyi,
• Fudan Cancer Hospital — Shanghai,
• Shanghai East Hospital — Shanghai,
• Union Hospital Tongji Medical College of Huazhong University of Science and Technology — Wuhan,
• Institut Sainte Catherine — Avignon,
• Centre Oscar Lambret — Lille,
• CHU Nantes — Nantes,
• Institut Curie — Paris,

📞 Contact the Study Coordinator

Phone: (844) 434-4210

Email: Participate-In-This-Study1@its.jnj.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Squamous Cell Carcinoma of Head and Neck

• Pembrolizumab Plus Olaparib in LA-HNSCC — Indianapolis, Indiana
• TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC — Tampa, Florida
• Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas — Philadelphia, Pennsylvania
• 5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC — New Haven, Connecticut
• HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer — Dallas, Texas

Explore by condition: All Squamous Cell Carcinoma of Head and Neck clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.