Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Paul Strauss

About this trial

This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with recurrent squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease

Tumor directly accessible to clinical examination (tumor of oral cavity and of oropharynx) and/or cervical lymphadenopathy accessible to echography allowing to realise biopsy under local anesthesia

Indication to treatment by anti-PD1 immunotherapy according to French competent authority recommendations

Performance status 0, 1 or 2

Disqualifiers

Head and neck squamous cell carcinoma accessible to a local treatment

Cancer of nasopharynx, sinus or nasal cavity

Other histology than epidermoid

Patients with contraindication for anti-PD1 immunotherapy

Trial population

Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease and with an indication to treatment by anti-PD1 immunotherapy

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Immunotherapy

    Drug

    anti-PD1

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Recurrent and/or metastatic head and neck carcinoma1 intervention

Trial outcomes

Primary outcomes

1

prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.

objective response according to RECIST v1.1 (response evaluation criteria in solid tumours)

Time frame
at 3 months after initiation of immunotherapy
2

prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.

objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)

Time frame
at 3 months after initiation of immunotherapy

Secondary outcomes

1

Prospective validation of the expression of interferon-gamma signature to predict progression free survival.

Time from date of inclusion to the event of tumor recurrence or clinical progression or radiological progression on primary tumor or on lymph nodes or on metastasis or death whatever the cause.

Time frame
at 3 years after inclusion
2

Prospective validation of the expression of interferon-gamma signature to predict overall survival.

Time from date of inclusion to death whatever the cause.

Time frame
at 3 years after inclusion
3

Prospective validation of the expression of interferon-gamma signature to predict duration of objective response.

Time from date of first observation of objective response to progressive disease according to RECIST v1.1 or death..

Time frame
at 3 years after inclusion
4

Exploratory outcome : investigation of the expression of other molecular signatures such as immune cells panel within the tumor microenvironment to predict anti-PD1 immunotherapy response.

objective response according to RECIST v1.1

Time frame
at 3 months after initiation of immunotherapy

Other outcomes

Sponsors and contacts

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Centre Paul Strauss

Lead sponsor

Centre National de la Recherche Scientifique, France

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator