Clinical Trials Logo

Clinical Trial Summary

This is a phase II study for patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation (with or without systemic therapy). Patients must be diagnosed with residual disease within 24 weeks of completion of radiation therapy. Residual disease must be biopsy proven before the patient can consent to the trial, and can be either from lymph nodes in the neck, or from the primary tumor site. Prior to beginning study therapy patients are evaluated by an ENT to determine if they have disease amenable to surgical resection. Both resectable and unresectable patients will be eligible for participation in the study.


Clinical Trial Description

The primary objective is to determine the overall response rate based on the immune related response criteria (irRC) to pembrolizumab for patients with residual disease following radiation with or without systemic therapy for squamous cell carcinoma of the head and neck.

Hypothesis: The use of pembrolizumab in patients with residual disease following radiation with or without systemic therapy will lead to an enhanced overall response rate due to chemoradiation-related priming of the immune response. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02892201
Study type Interventional
Source Yale University
Contact Tara McPartland
Phone 293-737-7173
Email tara.mcpartland@yale.edu
Status Recruiting
Phase Phase 2
Start date November 2016
Completion date May 2019

See also
  Status Clinical Trial Phase
Recruiting NCT03317327 - REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors Phase 1/Phase 2
Recruiting NCT03247309 - TCR-engineered T Cells in NSCLC and HNSCC Patients (ACTengine) Phase 1
Recruiting NCT03070366 - Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC Phase 2
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Recruiting NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Terminated NCT02488629 - Study of SCB01A in Patient With Head and Neck Cancer Phase 2
Recruiting NCT01697800 - A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract Phase 2
Recruiting NCT01427478 - Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck Phase 3
Suspended NCT02567422 - VX-970, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced HPV-Negative Head and Neck Squamous Cell Carcinoma Phase 1
Recruiting NCT03260023 - Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers and Expansion Cohort to Oropharyngeal SCCHN Phase 1/Phase 2
Recruiting NCT03196843 - Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With HNSCC. Phase 4
Active, not recruiting NCT02538510 - Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery Phase 1/Phase 2
Recruiting NCT03022409 - A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Phase 1
Active, not recruiting NCT02255097 - Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055) Phase 2
Active, not recruiting NCT01711541 - Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer Phase 1/Phase 2
Recruiting NCT02639858 - Study to Evaluate the Efficacy and Safety of Docetaxel Polymeric Micelle (PM) in Recurrent or Metastatic HNSCC Phase 2
Recruiting NCT02576431 - Study of LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion Positive Solid Tumors (NAVIGATE) Phase 2
Recruiting NCT02678884 - Head and Neck Squamous Cell Carcinoma (HNSCC)PET-CT Pilot Study N/A
Active, not recruiting NCT02268695 - Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC Phase 2
Active, not recruiting NCT00957853 - Preoperative Treatment With Cetuximab and/or IMC-A12 Phase 2