Clinical trial · Observational
Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma
NCT05328024CI-TRIAL-00113756IPRICErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Drug | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Recurrent and/or metastatic head and neck carcinoma
- description
- Patients with indication of anti-PD1 immunotherapy according to recommendations
- interventionNames
- Drug: Immunotherapy
Primary outcomes (2)
- measure
- prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.
- timeFrame
- at 3 months after initiation of immunotherapy
- description
- objective response according to RECIST v1.1 (response evaluation criteria in solid tumours)
- measure
- prospective validation of the expression of interferon-gamma signature to predict anti-PD1 immunotherapy response.
- timeFrame
- at 3 months after initiation of immunotherapy
- description
- objective response according to iRECIST criteria (immune response evaluation criteria in solid tumours)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * At least one measurable lesion on RECIST V1.1 criteria Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDHelene C, Conrad O, Pflumio C, Borel C, Voegelin M, Bernard A, Schultz P, Onea MA, Jung A, Martin S, Burgy M. Dynamic profiling of immune microenvironment during anti-PD-1 immunotherapy for head and neck squamous cell carcinoma: the IPRICE study. BMC Cancer. 2023 Dec 8;23(1):1209. doi: 10.1186/s12885-023-11672-x. PMID 38066522