Oral Squamous Cell Carcinoma (OSCC)NCT07015333
Case Review of Patients With Betel Nut-induced Oral Cancer Treated With Pembrolizumab and Cetuximab
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by Commonwealth Healthcare Corporation at 1 site in Northern Mariana Islands.
Trial summary
Chart review of records of patients treated for betel nut-induced oral cancer with pembrolizumab and cetuximab. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- pembrolizumab and cetuximab
- Type of treatment
- Pill or oral medicine
- How many people
- 31 participants
- Where
- 1 siteNorthern Mariana Islands
- Study dates
- 1 Mar 2020to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced betel nut-induced oral cancer
Who may be able to join
- Advanced betel nut-induced oral cancer
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Northern Mariana Islands1 site
CHCC
Saipan, MP, 96950
About this study
Chart review of records of patients treated for betel nut-induced oral cancer with pembrolizumab and cetuximab.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- pembrolizumab and cetuximab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pembrolizumab and cetuximabDrug
Treatment of betel nut-induced oral cancer with pembrolizumab and cetuximab
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Assessed by clinical measurement of largest tumor size
Measured: From date first treatment received until 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Mar 2020
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Commonwealth Healthcare Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Brett, MD, Commonwealth Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015333
- Sponsor's protocol ID
- 5-2025 Oral Cancer
- Status last verified
- Jun 2025
- First submitted
- 25 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Review of Patients With Betel Nut-induced Oral Cancer Treated With Pembrolizumab and Cetuximab
- ClinicalTrials.gov ID
- NCT07015333
- Acronym / sponsor ID
- 5-2025 Oral Cancer
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Commonwealth Healthcare CorporationUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chart review of records of patients treated for betel nut-induced oral cancer with pembrolizumab and cetuximab.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced betel nut-induced oral cancer
Key inclusion criteria (1 listed)
- Advanced betel nut-induced oral cancer
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumab and cetuximabTreatment of betel nut-induced oral cancer with pembrolizumab and cetuximab | Drug | – |
Primary outcome
Objective Response Rate (ORR)
Time frame: From date first treatment received until 3 months later
Assessed by clinical measurement of largest tumor size
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma (OSCC), run by Commonwealth Healthcare Corporation at 1 site in Northern Mariana Islands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Northern Mariana Islands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From date first treatment received until 3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.