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NCT06385080 · ClinicalTrials.gov registry record · Phase 1

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

A Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 1
Development phase
287
Enrollment target
20
Study locations

NCT06385080: Recruiting Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Janssen Research & Development.

NCT06385080 is a Phase 1 study of Squamous Cell Carcinoma of Head and Neck that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 287 participants, above the 163-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06385080, a Phase 1 study of Squamous Cell Carcinoma of Head and Neck, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 1
Development phase
287 participants
Enrollment target
20
Study locations

Study Summary

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

ORR is defined as the proportion of participants who achieve either a partial response (PR) or complete response (CR), as defined by investigator assessment using Response Criteria in Solid Tumors (RECIST) version 1.1.

Conditions Studied

Squamous Cell Carcinoma of Head and Neck

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Carboplatin
  • DRUG Paclitaxel
  • BIOLOGICAL Amivantamab

Study Locations (20)

Other

  • Beijing Cancer Hospital of Peking University - Beijing
  • West China School of Medicine/West China Hospital, Sichuan University - Cheng Du Shi
  • Linyi Cancer Hospital - Linyi
  • Fudan Cancer Hospital - Shanghai
  • Shanghai East Hospital - Shanghai
  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology - Wuhan

Michigan

  • University of Michigan Rogel Cancer Center - Ann Arbor
  • Karmanos Cancer Institute - Detroit

Virginia

  • University of Virginia - Charlottesville
  • Virginia Cancer Specialists - Fairfax

California

  • University of California at San Diego Moores Cancer Center - La Jolla

Colorado

  • University of Colorado Denver Anschultz Medical Campus - Aurora

Connecticut

  • Yale Cancer Center - New Haven

Illinois

  • The University of Chicago Medical Center (UCMC) - Chicago

Maryland

  • University of Maryland School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 287 participants
Start Date 2024-04-22
Est. Completion 2032-12-27
Phase Phase 1
Janssen Research & Development

593 total trials

What NCT06385080 shows while recruiting

NCT06385080 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, above the 163-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (76% higher).

The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT06385080 names 20 study sites across 13 states, led by Other, Michigan, Virginia.

Frequently Asked Questions

What is clinical trial NCT06385080 about?

NCT06385080 is a clinical study titled "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 c...

What is the current status of trial NCT06385080?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 287 participants. The study started on 2024-04-22. Estimated completion is 2032-12-27.

What conditions does trial NCT06385080 study?

This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.

What interventions are being tested in trial NCT06385080?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Paclitaxel (DRUG), Amivantamab (BIOLOGICAL).

Who is sponsoring clinical trial NCT06385080?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06385080 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Squamous Cell Carcinoma of Head and Neck

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06385080's enrollment target sits among peer trials

287 6th of 37 higher than 32 of 37 other Squamous Cell Carcinoma of Head and Neck trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06385080

Source: ClinicalTrials.gov NCT06385080, the US trial registry maintained by the National Library of Medicine. NCT06385080 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.