NCT07733466

Brief Summary

The goal of this clinical trial is to learn the overall response rate of giving immunothrapy before surgery in treatment-naive, advanced stage patients with Betal-nut-associated oral cavity cancer. The outcomes to be measured by CT scan are overall response rate of either partial or complete response.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
58mo left

Started Aug 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 27, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

3.9 years

First QC Date

June 27, 2026

Last Update Submit

July 23, 2026

Conditions

Betel-nut-associated Oral Carcinoma

Keywords

cetuximabpembrolizumabimmunotherapybetel-nut

Outcome Measures

Primary Outcomes (1)

  • 1.Overall Response Rate to neoadjuvant immunotherapy in patients with treatment naive Stage IIII-IV betal-nut-associated oral cavity carcinoma

    Assess ORR by CT scan using RECIST 1.1 in patients with treatment naive, advanced Stage III-IV Betel-Nut Associated oral cavity squamous cell carcinoma

    Baseline through 84 weeks

Secondary Outcomes (1)

  • 1. To evaluate median and 3-year disease-free survival (DFS) following treatment initiation

    Baseline to 36 months

Other Outcomes (12)

  • To evaluate overall survival

    Baseline to 36 months

  • To evaluate recurrence-free survival

    Baseline to 36 months

  • To characterize safety and tolerability of this neoadjuvant treatment regimen

    Baseline to 84 weeks

  • +9 more other outcomes

Study Arms (1)

Neoadjuvant pembrolizumab and cetuximab

OTHER

neoadjuvant treatment

Drug: Pembrolizumab and cetuximab

Interventions

Pembrolizumab and cetuximabDRUG

neoadjuvant immunotherapy using: 400 mg IV pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph 760 mg SQ given 2 times with cetuximab 500 mg/m2 IV every 2 weeks over a 12 week period.

Neoadjuvant pembrolizumab and cetuximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented history of betel-nut chewing
  • confirmed oral cavity squamous cell carcinoma
  • measurable disease via RECIST 1.1
  • Clinical stage III/IV per AJCC 8th edication
  • treatment-naive
  • ECOG 0-3

You may not qualify if:

  • Distant metastatic disease
  • prior treatment for current cancer
  • active immune diease or other condition requiring immunoupression or chronic corticosteroid use
  • active pneumonitis
  • known hypersensitivity to pembrolizumab or cetuximab
  • pregnant or breast-feeding
  • women of childbearing potential without willingness to use contraception during the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Marianas Oncology Center | Commonwealth Healthcare Corporation

Saipan, 96950, Northern Mariana Islands

Location

Related Publications (7)

  • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

    PMID: 2702835BACKGROUND

  • Yang J, Wang ZY, Huang L, Yu TL, Wan SQ, Song J, Zhang BL, Hu M. Do betel quid and areca nut chewing deteriorate prognosis of oral cancer? A systematic review, meta-analysis, and research agenda. Oral Dis. 2021 Sep;27(6):1366-1375. doi: 10.1111/odi.13456. Epub 2020 Jun 26.

    PMID: 32492239BACKGROUND

  • Narayanan AM, Finegersh A, Chang MP, Ogo J, Orosco RK, Moss WJ. The profound oral cavity cancer burden in the United States Commonwealth of the Northern Mariana Islands: A global health opportunity. Am J Otolaryngol. 2019 Nov-Dec;40(6):102267. doi: 10.1016/j.amjoto.2019.07.011. Epub 2019 Jul 19.

    PMID: 31351740BACKGROUND

  • Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.

    PMID: 31679945BACKGROUND

  • Rumgay H, Nethan ST, Shah R, Vignat J, Ayo-Yusuf O, Chaturvedi P, Guerra ENS, Gupta PC, Gupta R, Liu S, Magnusson C, Parascandola M, Paulino YC, Rezaei N, Siddiqi K, Warnakulasuriya S, Lauby-Secretan B, Soerjomataram I. Global burden of oral cancer in 2022 attributable to smokeless tobacco and areca nut consumption: a population attributable fraction analysis. Lancet Oncol. 2024 Nov;25(11):1413-1423. doi: 10.1016/S1470-2045(24)00458-3. Epub 2024 Oct 8.

    PMID: 39393386BACKGROUND

  • Sacco AG, Chen R, Worden FP, Wong DJL, Adkins D, Swiecicki P, Chai-Ho W, Oppelt P, Ghosh D, Bykowski J, Molinolo A, Pittman E, Estrada MV, Gold K, Daniels G, Lippman SM, Natsuhara A, Messer K, Cohen EEW. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):883-892. doi: 10.1016/S1470-2045(21)00136-4. Epub 2021 May 11.

    PMID: 33989559BACKGROUND

  • Yao Z, Wang J, Jiang Y, Zhang Y, Liu J, Dai L, Shen S, Zhou X, Liu Q, Zheng L, Qian M, Li J. Pembrolizumab plus cetuximab with neoadjuvant chemotherapy for head and neck squamous cell carcinoma. Head Neck. 2025 Jan;47(1):289-299. doi: 10.1002/hed.27915. Epub 2024 Aug 13.

    PMID: 39138647BACKGROUND

MeSH Terms

Interventions

pembrolizumabCetuximab

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Peter Brett, MD

CONTACT

(670) 234-8950peter.brett@chcc.health

Angela Figueroa, BSN, RN

CONTACT

(670) 234-8951angeela.figueroa@chcc.health

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: neoadjuvant
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2026

First Posted

July 29, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

June 1, 2031

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Patient data

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
From entry of 1st patient to last patient treated
Access Criteria
To be shared with surgeons at University of Southern California who will resect residual tumor 2-6 weeks following cessation of neoadjuvant treatment.

Locations

NO(1)