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A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Squamous Cell Carcinoma of Head and Neck
Clinicaltrials.gov:
EU CTIS:
#2023-508418-40-00
Other:
#61186372HNC2002
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Trials at a glance
Status
Enrolling
Condition
Squamous Cell Carcinoma of Head and Neck
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
Amivantamab
Carboplatin
Paclitaxel
Pembrolizumab
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
April 22, 2024
Trial end date
December 27, 2032
CT.gov ID
#NCT06385080
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Primary outcome measures
- 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)
Secondary outcome measures
- Cohorts 1, 2, 3B, 4 and 5: Duration of Response (DoR)
- Cohorts 1, 2, 3B, 4 and 5: Clinical Benefit Rate (CBR)
- Cohorts 1, 2, 3B, 4 and 5: Progression-free Survival (PFS)
- Cohorts 1, 2, 3B, 4, 5 and 6: Overall Survival (OS)
- Cohorts 1, 2, 3B, 4, 5 and 6: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
- Cohort 1 and 4: Maximum Observed Serum Concentration (Cmax) of Amivantamab
- Cohort 1 and 4: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab
- Cohort 1 and 4: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab
- Cohort 1 and 4: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab
- Cohort 1 and 4: Trough Serum Concentration (Ctrough) of Amivantamab
- Cohort 1 and 4: Accumulation Ratio (R) of Amivantamab
- Cohort 6: Event-Free Survival (EFS)
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