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Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists (CHECK'UP)

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ClinicalTrials.gov Identifier: NCT03412058
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Fondation ARC
Information provided by (Responsible Party):
UNICANCER

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Non Small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Procedure: Biopsy Not Applicable

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 RECIST and iRECIST criteria. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Cohort Study to Identify the Predictive Factors of Response to PD-1 or PD-L1 Antagonists
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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
Procedure: Biopsy
To be performed prior to anti-PD1/PD-L1 treatment initiation

Procedure: Biopsy
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients

Procedure: Biopsy
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
Procedure: Biopsy
To be performed prior to anti-PD1/PD-L1 treatment initiation

Procedure: Biopsy
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients

Procedure: Biopsy
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
Procedure: Biopsy
To be performed prior to anti-PD1/PD-L1 treatment initiation

Procedure: Biopsy
To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients

Procedure: Biopsy
To be performed at disease progression if medically feasible




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Objective response [ Time Frame: 84 days ]
    Objective response as assessed by Investigators according to RECIST v1.1.

  3. Objective response [ Time Frame: 84 days ]
    Objective response as assessed centrally according to RECIST v1.1.

  4. 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. iProgression-free survival [ Time Frame: 5 years ]
    defined as the time from inclusion until documented PD according to iRECIST or death, whichever occurs first.

  6. Overall survival [ Time Frame: 5 years ]
    defined as the time from inclusion until death due to any cause.

  7. 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

  8. 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

  9. Tumour size [ Time Frame: 5 years ]
    Changes in tumour size over time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old.
  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 (Appendix 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:

  1. Any contraindication to treatment with a PD-1 or PD-L1 antagonist.
  2. Any contraindication to a biopsy including: platelets < 80x109/L, International Normalised Ratio (INR) > 1.5 or prothrombin time (PT) > 1.5x 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412058


Contacts
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Contact: Daniel Couch 0180501296 d-couch@unicancer.fr

Locations
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France
Institut Bergonie Not yet recruiting
Bordeaux, France
Contact: Antoine Italiano         
Centre Hospitalier de Caen Not yet recruiting
Caen, France
Contact: Jeannick MADELAINE         
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Frédérique Penault-Llorca         
Centre Hospitalier Inter. de Creteil Not yet recruiting
Créteil, France
Contact: Isabelle MONNET         
Centre Georges François Leclerc Recruiting
Dijon, France
Contact: Nicolas Isambert         
Centre Oscar lambret Not yet recruiting
Lille, France
Contact: Eric Dansin         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Maurice Pérol         
Institut Régional du Cancer de Montpellier Not yet recruiting
Montpellier, France
Contact: QUANTIN Xavier         
Institut de cancérologie de l'ouest Not yet recruiting
Nantes, France
Contact: Judith Raimbourg         
Centre Antoine Lacassagne Not yet recruiting
Nice, France
Contact: Esma SAADA BOUZID         
Institut Curie Recruiting
Paris, France
Contact: Christophe Le Tourneau         
Institut Jean Godinot Not yet recruiting
Reims, France
Contact: Alain Prevost         
Centre Eugène Marquis Not yet recruiting
Rennes, France
Contact: Thierry Lesimple         
Institut Curie - Hôpital René Huguenin Not yet recruiting
Saint-Cloud, France
Contact: Christophe LE TOURNEAU         
CHU Saint-Etienne, Hôpital Nord Not yet recruiting
Saint-Étienne, France
Contact: Jean-Luc PERROT         
Institut Claudius Regaud - IUCT- 0 Not yet recruiting
Toulouse, France
Contact: Jean-Pierre Delord         
CHU de Tours Not yet recruiting
Tours, France
Contact: Sylvain MORINIERE         
Institut Cancérologie de Lorraine Not yet recruiting
Vandœuvre-lès-Nancy, France
Contact: Yolanda FERNANDEZ         
Gustave Roussy Not yet recruiting
Villejuif, France
Contact: Gilles Vassal         
Sponsors and Collaborators
UNICANCER
Fondation ARC
Investigators
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Principal Investigator: Frédérique Penault-Llorca Centre Jean Perrin

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03412058     History of Changes
Other Study ID Numbers: UC-0108/1708
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
PD-1
PD-L1
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Head and Neck Neoplasms