Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT05726370
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Immunoglobulin G4 monoclonal antibody, via IV infusion
  • CISPLATIN — DRUG
    Platinum agent, via IV infusion
  • Carboplatin — DRUG
    Platinum agent, via IV infusion
  • Docetaxel — DRUG
    Antineoplastic agent, via IV infusion.

Study Details

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)

Key Dates

Start date
May 20, 2023
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
May 20, 2030

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-Operative Treatment + Salvage Surgery + Adjuvant Treatment
    Participants will complete study procedures as outlined: Preoperative Phase: * Mandatory biopsy at baseline. * Neoadjuvant treatment (2 cycles): * Cycles 1 - 2 ---Day 1 of 21-day Cycle: Predetermined doses of Pembrolizumab, Cisplatin (or Carboplatin) and Docetaxel. Surgery: -Primary tumor resection and/or lymph node dissection surgery 3-6 weeks from cycle 2 day 1 Adjuvant Phase: -3-8 weeks post-surgery and upto a total of 15 cycles --Cycles 3 - 17 ---Day 1 of 21-day cycle: Predetermined dose of Pembrolizumab Follow up appointments

Primary Outcome Measure

Rate of Major Pathological Response (mPR) [ Time Frame: 2 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Kartik Sehgal, MD
[email protected]
617-632-3090
Kartik Sehgal, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Kartik Sehgal, MD
[email protected]
617-582-7322

Find similar trials in Boston, MA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

Related Studies