Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

  • Clinical Trial Information

    Trial Contact: Casillas, Bridey L; Ribacchi, Stephanie; Durand, Jennifer

  • IRB No: W22.116.05

    Protocol Abbrev: MK3475-689

    Principal Investigator: Jennifer E. Tseng, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: 689-06

    Treatment: Arm 1: Experimental: Pembro Neoadjuvant+Pembro SOC Adjuvant (Pembro 200mg) with Radiotherapy (day 60, 66, 70) and Cisplatin (100mg) Arm 2: No Neoadjuvant+SOC adjuvant with Radiotherapy (day 60, 66, 70) and Cisplatin (100mg)

    Therapies Involved: Chemotherapy; Oncology: Neo-adjuvant ID: NCT03765918

  • Objective

    This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

  • Key Eligibility

    -18 Years or older

    -Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries

    -Is eligible for primary surgery based on investigator decision and per local practice

    -Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy

    -Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy

    -Female participant that is not pregnant or breastfeeding

    -Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST version 1.1

    -Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

    -Has results from testing of HPV status for oropharyngeal cancer defined as p16

    -Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization