Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
An Open-Label, Phase 2 Efficacy Study With Window of Opportunity Immune Assessment of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.
This is a prospective, multi-center, open label, phase II study with a window of opportunity component in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with adjuvant pembrolizumab following salvage surgery. Forty-five (45) patients will participate in this study to determine disease-free survival probability at 12 months. Secondary objectives include assessments of disease-free survival probability at 2 years, overall survival, adverse events and toxicity, and immune and molecular correlatives. For the window of opportunity component, patients will be randomized 3:1 in favor of receiving pembrolizumab 200 mg administered intravenously (IV) every three weeks for a maximum of two doses, versus placebo prior to salvage surgery. Approximately three to six weeks following the first dose of pembrolizumab, patients will undergo salvage surgery. Tumor tissue and blood will be collected at the time of surgery for immune correlative studies. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Recruiting |
NCT06236464 -
Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas
|
||
| Terminated |
NCT04659369 -
Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
|
Phase 1 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT02572778 -
Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer
|
||
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 | |
| Terminated |
NCT01488318 -
Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT00999700 -
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
|
Phase 3 | |
| Completed |
NCT02565758 -
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02543476 -
SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
|
N/A | |
| Recruiting |
NCT03938012 -
Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma
|
||
| Terminated |
NCT02124850 -
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
|
Phase 1 | |
| Active, not recruiting |
NCT03313804 -
Priming Immunotherapy in Advanced Disease With Radiation
|
Phase 2 | |
| Recruiting |
NCT05208762 -
A Study of SGN-PDL1V in Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT04453046 -
Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
|
N/A | |
| Completed |
NCT01758731 -
Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History
|
Phase 1 | |
| Completed |
NCT02473731 -
A Window of Opportunity Study of KTN3379 in Surgically Resectable Head and Neck Cancer Patients
|
Phase 1 | |
| Completed |
NCT02022098 -
Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
|
N/A | |
| Completed |
NCT01458392 -
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
| Completed |
NCT02882308 -
Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.
|
Phase 2 |