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 OrigAMI-4

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508418-40-00

Acronym

61186372HNC2002

Enrollment

Registered

2024-06-07

Start date

2024-12-16

Completion date

Unknown

Last updated

2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

Brief summary

Cohorts 1, 2, 3b and 5: ORR, according to RECIST v1.1. Cohort 3A: - Incidence of DLTs - Incidence and severity of TEAEs Cohort 6: - MPR

Interventions

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGJNJ-61186372

DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cohorts 1, 2, 3b and 5: ORR, according to RECIST v1.1. Cohort 3A: - Incidence of DLTs - Incidence and severity of TEAEs Cohort 6: - MPR	—

Countries

France, Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026