Oropharyngeal Cancer Clinical Trial
Official title:
A Phase 2 Study to Assess the Effect of BALSTILIMAB (AGEN2034) on Viral Clearance in HPV-positive Oropharyngeal Cancer Patients With Persistent HPV Detection in Plasma cfDNA After Definitive Therapy
This study aims to leverage this unique property of HPV+ OPC to detect possible minimal residual disease represented by persistent viral detection after the completion of definitive treatment. The study will offer adjuvant immune therapy to patients with persistent viral detection and evaluate the clearance of viral load. It will evaluate the rate of viral clearance with immune therapy and establish the link between viral clearance and long-term disease control.
Objectives: Primary Objective: To assess whether anti-PD1 will lead to the clearance of the virus in the plasma cfDNA in HPV+ OPC patients with persistent cfDNA HPV following definitive therapy Secondary Objectives: - One-year recurrence-free survival (1-yr RFS), - 2-year RFS (2-yr RFS), - Overall survival (2-yr OS), - Safety and tolerability - Compliance - Quality of life (EORTC C30 will be utilized) Correlative/Exploratory Objectives: - Time to viral clearance in the oral rinse and plasma cfDNA with anti-PD1 treatment - The concordance between plasma HPV and oral rinse HPV at diagnosis, post-definitive treatment and during adjuvant treatment - The correlation between tumor mutations and persistence of HPV in oral rinse/cfDNA. - The correlation between recurrence site (loco-regional vs. distant metastasis) and oral rinse vs. plasma HPV detection ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03656133 -
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
|
N/A | |
| Terminated |
NCT02225496 -
Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
|
Phase 2 | |
| Withdrawn |
NCT01767961 -
Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer
|
N/A | |
| Completed |
NCT01695122 -
Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT01435252 -
A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab
|
Phase 2 | |
| Recruiting |
NCT04708470 -
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT00951470 -
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema
|
N/A | |
| Completed |
NCT01358097 -
Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy
|
N/A | |
| Completed |
NCT01342978 -
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
|
N/A | |
| Completed |
NCT00964977 -
Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
|
Phase 3 | |
| Completed |
NCT02280811 -
T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers
|
Phase 2 | |
| Active, not recruiting |
NCT03777384 -
EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
|
||
| Active, not recruiting |
NCT03729518 -
TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
|
N/A | |
| Recruiting |
NCT06121102 -
Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain
|
N/A | |
| Recruiting |
NCT02984410 -
Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma
|
N/A | |
| Recruiting |
NCT02960724 -
uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
|
Phase 2 | |
| Completed |
NCT02934724 -
Impact of HPV Vaccine On The Prevalence Of HPV In Norway
|
||
| Withdrawn |
NCT00928161 -
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
|
N/A | |
| Recruiting |
NCT02012699 -
Integrated Cancer Repository for Cancer Research
|
||
| Terminated |
NCT03555721 -
CytID Analysis of Oral Lesions
|