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Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC

NCT05726370 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-06-22

No results posted yet for this study

Summary

This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery.

The names of the study drugs involved in this research study are:

* pembrolizumab (a type of immunotherapy)
* docetaxel (a type of chemotherapy)
* cisplatin (a type of chemotherapy)
* carboplatin (a type of chemotherapy)

Conditions

Interventions

DRUG

Pembrolizumab

Immunoglobulin G4 monoclonal antibody, via IV infusion

DRUG

CISPLATIN

Platinum agent, via IV infusion

DRUG

Carboplatin

Platinum agent, via IV infusion

DRUG

Docetaxel

Antineoplastic agent, via IV infusion.

Sponsors & Collaborators

Principal Investigators

  • Kartik Sehgal, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-20
Primary Completion
2027-12-31
Completion
2030-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726370 on ClinicalTrials.gov