- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03412058
Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists (CHECK'UP)
Prospective Cohort Study to Identify the Predictive Factors of Response to PD-1 or PD-L1 Antagonists
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- Institut Bergonié
-
Caen, France
- Centre Hospitalier de Caen
-
Clermont-Ferrand, France, 63011
- Centre Jean Perrin
-
Créteil, France
- Centre Hospitalier Inter. de Creteil
-
Dijon, France
- Centre Georges Francois Leclerc
-
Lille, France
- Centre Oscar Lambret
-
Lyon, France
- Centre Leon Berard
-
Montpellier, France
- Institut Regional du Cancer de Montpellier
-
Nantes, France
- Institut de cancerologie de l'ouest
-
Nice, France
- Centre Antoine Lacassagne
-
Paris, France
- Institut Curie
-
Reims, France
- Institut Jean Godinot
-
Rennes, France
- Centre Eugene Marquis
-
Saint-Cloud, France
- Institut Curie - Hôpital René Huguenin
-
Saint-Étienne, France
- CHU Saint-Etienne, Hopital Nord
-
Toulouse, France
- Institut Claudius Regaud - IUCT- 0
-
Tours, France
- CHU de Tours
-
Vandœuvre-lès-Nancy, France
- Institut cancérologie de Lorraine
-
Villejuif, France
- Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years old.
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.
- 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.
- Estimated life expectancy ≥16 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
- Presence of at least one tumour lesion (except bone lesions) accessible to biopsy, if a biopsy is required (see below).
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.
- Measurable disease according to RECIST v1.1 (Eisenhauer, 2009).
- Beneficiary of social insurance coverage.
- Comprehension of French.
- Provision of written informed consent (signed and dated) prior to the initiation of any protocol specific procedure.
Exclusion Criteria:
- Any contraindication to treatment with a PD-1 or PD-L1 antagonist.
- 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.
- Bone metastasis as the only disease site available for biopsy.
- Previous treatment with a PD-1 or PD-L1 antagonist.
- Individuals deprived of liberty or placed under the authority of a tutor.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
To be performed prior to anti-PD1/PD-L1 treatment initiation
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
To be performed at disease progression if medically feasible
|
Experimental: 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
|
To be performed prior to anti-PD1/PD-L1 treatment initiation
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
To be performed at disease progression if medically feasible
|
Experimental: 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
|
To be performed prior to anti-PD1/PD-L1 treatment initiation
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
To be performed at disease progression if medically feasible
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of response signature
Time Frame: 84 days
|
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.
|
84 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and severity of adverse events occuring during the observation period
Time Frame: Through treatment period
|
Adverse events will be evaluated according to NCI-CTCAE v4
|
Through treatment period
|
Objective response
Time Frame: 84 days
|
Objective response as assessed by Investigators according to RECIST v1.1.
|
84 days
|
Objective response
Time Frame: 84 days
|
Objective response as assessed centrally according to RECIST v1.1.
|
84 days
|
Progression-free survival
Time Frame: 5 years
|
defined as the time from inclusion until documented disease progression (PD) according to RECIST v1.1, or death, whichever occurs first.
|
5 years
|
iProgression-free survival
Time Frame: 5 years
|
defined as the time from inclusion until documented PD according to iRECIST or death, whichever occurs first.
|
5 years
|
Overall survival
Time Frame: 5 years
|
defined as the time from inclusion until death due to any cause.
|
5 years
|
Duration of response
Time Frame: 5 years
|
defined as the time from first observation of objective response according to RECIST v.1.1 until PD or death, whichever occurs first
|
5 years
|
Treatment costs
Time Frame: 5 years
|
including cost of antiPD-1/PD-L1 treatment and supportive care for antiPD-1/PD-L1 treatment-related adverse events
|
5 years
|
Tumour size
Time Frame: 5 years
|
Changes in tumour size over time
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frédérique Penault-Llorca, Centre Jean Perrin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UC-0108/1708
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
-
H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
-
MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
-
National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
-
Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
Clinical Trials on Biopsy
-
UNICANCERNational Cancer Institute, FranceActive, not recruitingTriple-Negative Breast NeoplasmFrance
-
Postgraduate Institute of Medical Education and...CompletedLung Cancer | Endobronchial GrowthIndia
-
Chandan SenTerminatedWound Leg | Non-Diabetic Patients | Chronic Ulcer Leg/FootUnited States
-
Duke UniversityCompletedInterstitial Lung DiseaseUnited States
-
Centre Hospitalier Universitaire de NiceUnknownParodontitis Aggressive | Parodontitis ChronicFrance
-
Ardeshir RastinehadPhilips HealthcareRecruitingProstate Cancer | Prostate Disease | Elevated Prostate Specific Antigen | Family History of Prostate Cancer | Positive Digital Rectal ExamUnited States
-
Shandong Cancer Hospital and InstituteUnknownBreast Cancer | Sentinel Lymph NodeChina
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnCastration-Resistant Prostate Carcinoma | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer
-
Johns Hopkins UniversityCompleted
-
Odense University HospitalNot yet recruitingProstate Cancer (Diagnosis)