Neoplasms

All Conditions

Infections

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Virus Diseases

Papilloma

Extranodal Extension

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplasm Metastasis

Neoplastic Processes

Extranodal extension presence or absence on radiology and pathology assessment

Extranodal extension

Hisham Mehanna, PhD

Christina Henson, MD

Ahmad K. Abou-Foul, MD

Paul C Nankivell, PhD

Extranodal extension (ENE) refers to the spread of head and neck squamous cell carcinoma (HNSCC) outside the lymph nodes. It is a well-known factor that indicates a poorer prognosis and outcome for patients who have undergone surgical removal of the cancer. In such cases, it is recommended to combine chemotherapy with radiation therapy after surgery.

As the number of cases of HNSCC related to the human papillomavirus (HPV) is increasing, treatment approaches have shifted towards using radiation therapy as the primary treatment method instead of surgery. This raises an important question about the significance of ENE observed through imaging tests (referred to as iENE) and its impact on the prognosis. Unfortunately, this question remains unanswered.

The objective of this project is to conduct a comprehensive study across multiple medical institutions. The investigators will gather data including scan results, histopathology reports, and data from patient charts from individuals who have been treated for head and neck cancer. The aim is to analyze and correlate the findings between the pathological evidence of ENE and the imaging results, while also assessing the prognostic value of iENE. Additionally, the investigators will explore the influence of HPV status on these factors.

By collecting and analyzing this data, the investigators hope to establish standardized criteria that can assist radiologists in accurately identifying ENE through imaging tests. This research is essential for enhancing our understanding of HNSCC and improving the effectiveness of diagnostic procedures and treatment planning.

Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer

Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer Part of the Evaluation Prognostic and Predictive Indicators in Head and Neck Cancer (EPIC) Programme, Run Under the Auspices of the Head and Neck Inter Group (HNCIG, Www.Hncig.Org)

The data will bill kept in the HNCIG database, and might be shared with other researchers following a reasonable request (and following agreement by the HNCIG board)

Endpoints: Accuracy of a radiologic "call" of iENE (with pENE being the gold standard comparator) by radiologists not trained for any standardized diagnostic classification systems for iENE.

Endpoints: Overall survival rates based on presence of iENE and pENE

Endpoints: Recurrence rates based on presence of iENE and pENE

Endpoints: Overall survival rates based on presence of various degrees of iENE and pENE

Endpoints: Recurrence rates based on presence of various degrees of iENE and pENE

Endpoints: Diagnostic accuracy of various radiographic features of iENE with pENE.

Endpoints: Diagnostic accuracy of published standardized classification systems with pENE

Endpoints: Interobserver variability measured by Cohen's kappa

Head and Neck Cancer International Group

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Uterine Cervical Neoplasms

Penile Neoplasms

Neoplasms, Unknown Primary

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Male

Genital Diseases, Male

Penile Diseases

Male Urogenital Diseases

Penile Cancer

All Drugs and Chemicals

Vaccines

Arm 1A: 15 (6+9) patients with previously treated HPV16+ head and neck squamous cell carcinoma receiving increasing doses of HPV vaccine.

- COMPLETE no longer recruiting

Arm 1B: 29 (15+14) patients with HPV16+ advanced disease receiving increasing doses of HPV vaccine.

OPEN to recruitment

BNT113

Christian Ottensmeier, Prof

Ioannis Karydis, Dr

HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head \& Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine.

Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.

HARE-40 is a phase I/II vaccine dose escalation trial with two arms (Arm 1A and Arm 1B) in which we will test BNT113 as monotherapy. We will undertake a multi-centre phase I, open label trial in patients with previous HPV16+ HNSCC without current clinical evidence of disease (Arm 1A) and in patients with HPV16+ advanced disease (Arm 1B). The HPV16 antigen-specific immune response will be evaluated before and after treatment in circulating blood and, where samples have been collected, in tumour and skin biopsies.

Arms 1A and 1B will escalate BNT113 in each patient (intrapatient dose escalation) up to the specified target dose of the cohort to establish a safe, tolerable and recommended dose of BNT113 in patents who are disease free (Arm 1A) and those with advanced disease (Arm 1B).

Subset of patients in Arm 1B will also be assessed for response to the vaccine in terms of a significant increase of immune cells following BNT113 administration and according to irRECIST1.1 (all 29 patients including the expansion cohort) and other endpoints.

HARE-40: HPV Anti-CD40 RNA vaccinE

Therapeutic HPV Vaccine (BNT113) Trial in HPV16 Driven Carcinoma

Safe and tolerable dose of clinically disease free patients (Arm 1A) - Determination of a suitable dose of HPV RNA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer	NCT05936502	Head and Neck S... Extranodal Exte... Human Papilloma...	Extranodal exte...	18 Years -	Head and Neck Cancer International Group
HARE-40: HPV Anti-CD40 RNA vaccinE	NCT03418480	Human Papilloma... Head and Neck N... Cervical Neopla... Penile Neoplasm... Unknown Primary...	BNT113	18 Years -	University of Southampton
HARE-40: HPV Anti-CD40 RNA vaccinE	NCT03418480	Human Papilloma... Head and Neck N... Cervical Neopla... Penile Neoplasm... Unknown Primary...	BNT113	18 Years -	University of Southampton

Spots Global Cancer Trial Database for human papilloma virus related carcinoma