Clinical trial · no report yet · Phase 1/Phase 2
OrigAMI-4
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
- NCT06385080 ↗
- Recruiting
- Janssen Research & Development, LLC
- 30 commentary sources found
- Standard
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| YouTube | 16 | |
| Podcasts | 7 | |
| X threads | 6 | |
| X videos | 1 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 1/Phase 2
- Status
- Recruiting
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- Amivantamab; Pembrolizumab; Paclitaxel; Carboplatin
- Arms
- Cohort 1: Amivantamab Monotherapy (Dose Expansion) · Experimental
- Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in) · Experimental
- Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel · Experimental
- Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel · Experimental
- Cohort 4: Amivantamab Monotherapy · Experimental
- Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion) · Experimental
- Cohort 6: Amivantamab + Pembrolizumab · Experimental
- Enrollment
- 287 (estimated)
- Primary outcomes
- Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate
- Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)
- Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
- Cohort 6: Major Pathologic Response (MPR)
- Sponsor
- Janssen Research & Development, LLC
- Start
- Apr 22, 2024
- Primary completion
- Dec 27, 2032 (estimated)
- Results posted
- No
- Registry record
- NCT06385080 · updated Sep 25, 2026
Publications
linked from the registry- Burtness B, Rosenberg AJ, Calderon B, Lim SM, Yang MH, Li SH, Kadowaki S, Swiecicki PL, Geiger JL, Ince W, Hahn D, Guo Y, Adkins D, Metcalf R, Ahn MJ, Sukari A, Brana I, Keam B, Tanaka H, Sheth S, Oliva M, Lyu X, Curtin JC, Toyoizumi K, Xie J, Wade M, Diorio B, Kapoor A, Yilmaz E, Baig M, Kim P, Verheijen RB, Shah S, Harrington KJ; OrigAMI-4 Cohort 1 Investigators. Amivantamab in Recurrent/Metastatic Head and Neck Squamous Cell Cancer After Checkpoint Inhibitor and Chemotherapy: Pivotal Results From the Phase Ib/II OrigAMI-4 Study. J Clin Oncol. 2026 May 31:JCO2601042. doi: 10.1200/JCO-26-01042. Online ahead of print. PubMed 42218660