Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists
NCT ID: NCT03412058
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
670 participants
INTERVENTIONAL
2018-06-27
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Melanoma
Biopsy and blood samples will be collected from patients treated with an antiPD-1 or antiPD-L1 antibody with marketing authorization for the indication, during the course of their treatment
Biopsy
To be performed prior to anti-PD1/PD-L1 treatment initiation
Biopsy
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
Biopsy
To be performed at disease progression if medically feasible
NSCLC
Biopsy and blood samples will be collected from patients treated with an antiPD-1 or antiPD-L1 antibody with marketing authorization for the indication, during the course of their treatment
Biopsy
To be performed prior to anti-PD1/PD-L1 treatment initiation
Biopsy
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
Biopsy
To be performed at disease progression if medically feasible
HNSCC
Biopsy and blood samples will be collected from patients treated with an antiPD-1 or antiPD-L1 antibody with marketing authorization for the indication, during the course of their treatment
Biopsy
To be performed prior to anti-PD1/PD-L1 treatment initiation
Biopsy
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
Biopsy
To be performed at disease progression if medically feasible
Interventions
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Biopsy
To be performed prior to anti-PD1/PD-L1 treatment initiation
Biopsy
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
Biopsy
To be performed at disease progression if medically feasible
Eligibility Criteria
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Inclusion Criteria
2. Histological confirmed diagnosis of one of the following:
* Non-resectable (stage III) or metastatic (stage IV) melanoma,
* Metastatic, EGFR- and ALK-negative, non-small cell lung cancer with a high level of PD-L1 expression (defined as a "tumour proportion score" of greater than or equal to 50%) which has not been previously treated with chemotherapy in the metastatic setting,
* Head and Neck squamous cell carcinoma that is that is recurrent or progressing following reference chemotherapy and that is not amenable to surgery or radiation therapy.
3. Indicated for treatment with a PD-1 or PD-L1 antagonist according to the European Marketing Authorisation or the conditions of a Temporary Authorisation of Use.
4. Estimated life expectancy ≥16 weeks.
5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
6. Presence of at least one tumour lesion (except bone lesions) accessible to biopsy, if a biopsy is required (see below).
7. Willing and able to provide a pre-treatment biopsy sample, if a biopsy is required.
Note: where an archived tumour sample is available, this archived sample can be used in place of a fresh biopsy sample, if the patient has not received any antineoplastic therapy since the collection date.
8. Measurable disease according to RECIST v1.1 (Eisenhauer, 2009).
9. Beneficiary of social insurance coverage.
10. Comprehension of French.
11. Provision of written informed consent (signed and dated) prior to the initiation of any protocol specific procedure.
Exclusion Criteria
2. Any contraindication to a biopsy including: platelets \<80 x 10⁹/L, International Normalised Ratio (INR) \>1.5 or prothrombin time (PT) \>1.5 x upper limit of normal range (ULN), prolonged partial thromboplastin time (PTT) in the absence of factor XII deficiency or antiphospholipid antibodies, ongoing treatment with anticoagulants.
3. Bone metastasis as the only disease site available for biopsy.
4. Previous treatment with a PD-1 or PD-L1 antagonist.
5. Individuals deprived of liberty or placed under the authority of a tutor.
6. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
18 Years
ALL
No
Sponsors
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Fondation ARC
OTHER
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Frédérique Penault-Llorca
Role: PRINCIPAL_INVESTIGATOR
Centre Jean Perrin
Locations
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Institut Bergonie
Bordeaux, , France
Centre Hospitalier de Caen
Caen, , France
Centre Jean Perrin
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
Institut Curie
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Eugène Marquis
Rennes, , France
Institut Curie - Hôpital René Huguenin
Saint-Cloud, , France
CHU Saint-Etienne, Hôpital Nord
Saint-Etienne, , France
Institut Claudius Regaud - IUCT- 0
Toulouse, , France
CHU de Tours
Tours, , France
Institut Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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UC-0108/1708
Identifier Type: -
Identifier Source: org_study_id
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