Skip to content
DataLookout
Start free
Menu

OrigAMI-5NCT07276399

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 500 → 600 participants
    • Study completion pushed from Jun 18, 2029 to Jul 18, 2029
    • Study sites: 203 to 205
  2. Study sites: 201 to 203
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 12 entries
  3. Trial sites expanded: 198 → 201 locationsv10
  4. Study sites: 196 to 198v9
  5. Trial sites expanded: 186 → 196 locationsv8
  6. Trial sites expanded: 177 → 186 locationsv7
  7. Trial sites expanded: 160 → 177 locationsv6
  8. Trial sites expanded: 137 → 160 locationsv5
  9. Study sites: 99 to 137v4
  10. Study sites: 22 to 99v3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 22
    • Start date changed from estimate of Dec 29, 2025 to Dec 3, 2025
    v2
  12. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Overall Survival (OS)
Timeframe: Up to approximately 3 years 7 months
Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Timeframe: Up to approximately 3 years 7 months

Secondary (12)

Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR
Duration of Response (DOR) As Assessed by BICR
ORR as Assessed by Investigator
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Number of Participants with Laboratory Abnormalities
Show 7 moreShow less
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 Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score
Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score
Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30
Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30
Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores
Serum Concentration of Amivantamab
Number of Participants with Serum Anti-Amivantamab Antibodies

Arms and interventions

Arm A: Pembrolizumab, Amivantamab, CarboplatinExperimental

Participants will receive pembrolizumab, amivantamab and carboplatin.

Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or CisplatinActive comparator

Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).

Biologicals: Amivantamab, Pembrolizumab

Drugs: Carboplatin, 5-Flurouracil, Cisplatin

Sites

205 sites in 22 countries

United States 51, China 25, United Kingdom 11, France 9, Germany 9, Spain 9, Japan 8, Italy 7, Taiwan 7, Brazil 6, Czechia 6, Hungary 6, India 6, Mexico 6, Poland 6, Romania 6, Australia 5, Austria 5, Belgium 5, Portugal 5, South Korea 4, Netherlands 3