Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists

NCT03412058 | Active Not Recruiting

• 1 other identifier: UC-0108/1708
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 19

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.

Conditions

Melanoma; Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma

Keywords

PD-1; PD-L1

Outcome Measures

Primary Outcomes (1)

• 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.

  84 days

Secondary Outcomes (9)

• Frequency and severity of adverse events occuring during the observation period

  Through treatment period

• Objective response

  84 days

• Objective response

  84 days

• Progression-free survival

  5 years

• iProgression-free survival

  5 years

Study Arms (3)

Melanoma

EXPERIMENTAL

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

NSCLC

EXPERIMENTAL

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

HNSCC

EXPERIMENTAL

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

Interventions

Biopsy PROCEDURE

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

HNSCC; Melanoma; NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICANCER: lead
• Fondation ARC: collaborator

Study Sites (19)

Institut Bergonie

Bordeaux, France

Location

Centre Hospitalier de Caen

Caen, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Hospitalier Inter. de Creteil

Créteil, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Oscar lambret

Lille, France

Location

Centre Léon Bérard

Lyon, France

Location

Institut Régional du Cancer de Montpellier

Montpellier, France

Location

Institut de cancérologie de l'ouest

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Institut Curie

Paris, France

Location

Institut Jean Godinot

Reims, France

Location

Centre Eugène Marquis

Rennes, France

Location

Institut Curie - Hôpital René Huguenin

Saint-Cloud, France

Location

CHU Saint-Etienne, Hôpital Nord

Saint-Etienne, France

Location

Institut Claudius Regaud - IUCT- 0

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Institut Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

Gustave Roussy

Villejuif, France

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Frédérique Penault-Llorca

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: January 26, 2018
• Study Start: June 27, 2018
• Primary Completion: January 2, 2024
• Study Completion: December 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

FR (19)