A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma - OrigAMI-5

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011250045

Enrollment

500

Registered

2025-11-25

Start date

2026-01-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Experimental: Arm A: Pembrolizumab, Amivantamab, Carboplatin Participants will receive pembrolizumab, amivantamab and carboplatin. Biological/Vaccine: Amivantamab Amivantamab will be administered. Oth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Be more than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) - Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative - Be treatment-naive for systemic therapy in the R/M setting - Have an ECOG performance status of 0 or 1 - Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1

Exclusion criteria

Exclusion criteria: - Have an uncontrolled illness - Have untreated brain metastases or history of known presence of leptomeningeal disease - Have a history of clinically significant cardiovascular disease - Inadequate organ or bone marrow function - Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase

Design outcomes

Primary

Measure	Time frame
1. Overall Survival (OS) OS is defined as time from the date of randomization to the date of death due to any cause. [Time Frame: Up to approximately 3 years 7 months] 2. Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) ORR is defined as the percentage of randomized participants achieving a confirmed best overall response (BOR) of partial response (PR) or complete response (CR) by BICR using RECIST version 1.1 . [Time Frame: Up to approximately 3 years 7 months]	—

Measure

Time frame

1. Overall Survival (OS) OS is defined as time from the date of randomization to the date of death due to any cause. [Time Frame: Up to approximately 3 years 7 months] 2. Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) ORR is defined as the percentage of randomized participants achieving a confirmed best overall response (BOR) of partial response (PR) or complete response (CR) by BICR using RECIST version 1.1 . [Time Frame: Up to approximately 3 years 7 months]

—

Secondary

Measure	Time frame
3. Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, based on BICR assessment using RECIST v1.1, regardless of treatment discontinuation or start of subsequent anticancer therapy. [Time Frame: Up to approximately 3 years 7 months] 4. Duration of Response (DOR) As Assessed by BICR DOR as assessed by BICR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as best response. [Time Frame: Up to approximately 3 years 7 months] 5. ORR as Assessed by Investigator ORR as assessed by the investigator is defined as the percentage of randomized participants achieving CR or PR, as defined by investigator assessment using RECIST v1.1 criteria. [Time Frame: Up to approximately 3 years 7 months] 6. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event. [Time Frame: Up to approximately 3 years 7 months] 7. Number of Participants with Laboratory Abnormalities Blood samples will be collected to determine the laboratory (serum chemistry and hematology) abnormalities. [Time Frame: Up to approximately 3 years 7 months] 8. Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life	—

Measure

Time frame

3. Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, based on BICR assessment using RECIST v1.1, regardless of treatment discontinuation or start of subsequent anticancer therapy. [Time Frame: Up to approximately 3 years 7 months] 4. Duration of Response (DOR) As Assessed by BICR DOR as assessed by BICR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR as best response. [Time Frame: Up to approximately 3 years 7 months] 5. ORR as Assessed by Investigator ORR as assessed by the investigator is defined as the percentage of randomized participants achieving CR or PR, as defined by investigator assessment using RECIST v1.1 criteria. [Time Frame: Up to approximately 3 years 7 months] 6. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent therapy or any AE that is considered treatment-related regardless of the start date of the event. [Time Frame: Up to approximately 3 years 7 months] 7. Number of Participants with Laboratory Abnormalities Blood samples will be collected to determine the laboratory (serum chemistry and hematology) abnormalities. [Time Frame: Up to approximately 3 years 7 months] 8. Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life

—

Contacts

Public ContactMedical Information Center

Janssen Pharmaceutical K.K.

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com+81-120-183-275

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026