This is a prospective cohort study which aims to identify predictive factors of response to PD-1 and PD L1 antagonists authorised for use in France in treatment of melanoma, NSCLC, or HNSCC.
The study will include 670 patients with melanoma, NSCLC, or HNSCC who are set to receive treatment with a single-agent PD-1 or PD L1 antagonist regimen as indicated in the respective European MA or under the conditions of a TAU and according to the standard practices at the investigational site. Included patients will be followed for a total of 5 years. Prior to initiation of PD-1 or PD-L1 antagonist therapy, included patients will undergo a biopsy of a tumour lesion (unless suitable archived material is available) and provide a blood sample for immunohistochemistry and genomic studies. Patients at selected participating sites will also be asked to provide stool and saliva samples (optional). Additional optional biopsy samples may be collected from consenting patients after 42 (±3) days of PD-1 or PD-L1 antagonist treatment and in the event of disease progression or recurrence. Additional blood samples will also be collected at regular intervals throughout the observation period until disease progression, regardless of whether PD-1 or PD-L1 antagonist treatment is ongoing or has discontinued. Efficacy of treatment will be evaluated using both Response Evaluation Criteria in Solid Tumours (RECIST) and immune-related RECIST (iRECIST). Information regarding the PD-1 or PD-L1 antagonist related toxicities, subsequent antineoplastic treatments, and survival status will also be collected during the trial. An elastic-net approach will be used to identify correlations between different parameters and develop a signature of response to treatment. For each indication, the patients will be separated into two cohorts: a 'training' cohort and a 'validation' cohort. The 'training' cohort will be made up of the first patients included in the indication and will be used to develop a predictive response score. The 'validation' cohort will include all the remaining patients. The performance of the predictive score will be tested in this second cohort.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
670
Institut Bergonie
Bordeaux, France
Centre Hospitalier de Caen
Caen, France
Centre Jean Perrin
Sensitivity of response signature
The sensitivity is defined as the ratio of patients classified as responder by the signature to the number of patients presenting an objective response (CR or PR) according to centralized assessment of RECIST v1.1.
Time frame: 84 days
Frequency and severity of adverse events occuring during the observation period
Adverse events will be evaluated according to NCI-CTCAE v4
Time frame: Through treatment period
Objective response
Objective response as assessed by Investigators according to RECIST v1.1.
Time frame: 84 days
Objective response
Objective response as assessed centrally according to RECIST v1.1.
Time frame: 84 days
Progression-free survival
defined as the time from inclusion until documented disease progression (PD) according to RECIST v1.1, or death, whichever occurs first.
Time frame: 5 years
iProgression-free survival
defined as the time from inclusion until documented PD according to iRECIST or death, whichever occurs first.
Time frame: 5 years
Overall survival
defined as the time from inclusion until death due to any cause.
Time frame: 5 years
Duration of response
defined as the time from first observation of objective response according to RECIST v.1.1 until PD or death, whichever occurs first
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clermont-Ferrand, France
Centre Hospitalier Inter. de Creteil
Créteil, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar lambret
Lille, France
Centre Léon Bérard
Lyon, France
Institut Régional du Cancer de Montpellier
Montpellier, France
Institut de cancérologie de l'ouest
Nantes, France
Centre Antoine Lacassagne
Nice, France
...and 9 more locations
Time frame: 5 years
Treatment costs
including cost of antiPD-1/PD-L1 treatment and supportive care for antiPD-1/PD-L1 treatment-related adverse events
Time frame: 5 years
Tumour size
Changes in tumour size over time
Time frame: 5 years