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Led by Janssen Research & Development, LLC · Updated on 2026-07-06
287
Participants Needed
56
Research Sites
N/A
Total Duration
This research aims to evaluate the safety and preliminary effectiveness of amivantamab alone and combined with other treatments in participants with recurrent or metastatic head and neck squamous cell carcinoma HNSCC and in those with locally advanced HNSCC who can undergo surgery. The study also seeks to establish the recommended Phase 2 combination dose of amivantamab when given with paclitaxel. Additionally, the safety and effectiveness of amivantamab combined with pembrolizumab will be assessed before and after surgery in participants with resectable locally advanced HNSCC. Participants will receive subcutaneous injections of amivantamab at doses adjusted by body weight on specific schedules, either alone or combined with intravenous pembrolizumab, paclitaxel, or carboplatin, depending on their assigned cohort. Dose confirmation and expansion cohorts will help determine the appropriate dosing. For those in the perioperative setting, amivantamab and pembrolizumab will be given in both neoadjuvant before surgery and adjuvant after surgery phases with specific dosing schedules extending up to 15 cycles. Participants will be assessed for tumor response, treatment-related toxicities, and survival outcomes over a period extending up to about two years. Researchers will monitor treatment-emergent adverse events, dosing tolerability, and measure outcomes such as objective response rate, duration of response, progression-free survival, overall survival, and major pathologic response. Laboratory tests, imaging, and clinical evaluations will be performed to evaluate safety and efficacy throughout the study duration.
CONDITIONS
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
S
Study Contact
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Janssen Research & Development, LLC
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Amivantamab‑based regimens (various combinations) | Pembrolizumab‑based systemic therapy (current standard) |
|---|---|---|
| What it is | Investigational amivantamab‑based regimens (monotherapy or combinations with pembrolizumab, paclitaxel, carboplatin) evaluated across multiple dose‑expansion cohorts | Pembrolizumab alone or combined with platinum‑based chemotherapy represents current standard systemic therapy for recurrent or metastatic HNSCC |
| Role in study | Participants receive amivantamab, either alone or in combination with other agents, across sequential investigational cohorts | Used as comparator standard of systemic care outside the trial |
| Primary use | Treatment of recurrent/metastatic or locally advanced resectable HNSCC in different investigational regimens | Approved as frontline or subsequent systemic therapy in R/M HNSCC based on PD‑1 immune checkpoint blockade |
| Administration | Amivantamab is given subcutaneously alone or with intravenous agents (e.g., pembrolizumab, paclitaxel, carboplatin) per cohort | Pembrolizumab is given intravenously, sometimes with intravenous platinum‑based chemotherapy |
| Evidence status | OrigAMI‑4 early data show objective responses after prior platinum and immunotherapy in heavily pretreated R/M HNSCC | Pembrolizumab with or without chemotherapy improves survival outcomes compared to prior regimens in R/M HNSCC |
| Important risks | Risks include EGFR/MET‑related rash, hypoalbuminemia, administration reactions observed in cohort 1 | Immune‑related adverse events can occur with pembrolizumab, including rash, fatigue, endocrinopathies |
| Important limitations | Single‑group, non‑randomized early‑phase data; efficacy and safety not yet compared against standard care | Benefit may vary by PD‑L1 expression and patient fitness; not evaluable in post‑immunotherapy setting |
| Patient impact | Early responses may offer benefit to heavily pretreated patients, but clinical impact remains exploratory | Pembrolizumab‑based treatments have demonstrated survival benefit and quality‑of‑life maintenance in trials |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years and 2 months
Participants receive subcutaneous amivantamab alone or combined with intravenous pembrolizumab, paclitaxel, or carboplatin according to their assigned cohort. Dosing schedules include weekly injections during the first cycle, then every three weeks thereafter. Some participants receive neoadjuvant and adjuvant treatments around surgery.
Regular visits every 1 to 3 weeks depending on treatment schedule
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
Have more questions? Get in touch with our team for quick support
Barbara Burtness, Ari J Rosenberg, Benoit Calderon...
https://pubmed.ncbi.nlm.nih.gov/42218660/Janssen Research & Development, LLC
Lead Sponsor
