NCT07015333

Brief Summary

Chart review of records of patients treated for betel nut-induced oral cancer with pembrolizumab and cetuximab.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

4.7 years

First QC Date

May 25, 2025

Last Update Submit

June 7, 2025

Conditions

Oral Squamous Cell Carcinoma (OSCC)

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    Assessed by clinical measurement of largest tumor size

    From date first treatment received until 3 months later

Interventions

pembrolizumab and cetuximabDRUG

Treatment of betel nut-induced oral cancer with pembrolizumab and cetuximab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced betel nut-induced oral cancer

You may qualify if:

  • Advanced betel nut-induced oral cancer

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHCC

Saipan, MP, 96950, Northern Mariana Islands

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumabCetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Medical Oncology

Study Record Dates

First Submitted

May 25, 2025

First Posted

June 11, 2025

Study Start

March 1, 2020

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

June 11, 2025

Record last verified: 2025-06

Locations

NO(1)