Status:
ACTIVE_NOT_RECRUITING
Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Fondation ARC
Conditions:
Melanoma
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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 u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT03412058
Start Date
June 27 2018
End Date
December 1 2025
Last Update
February 20 2025
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Bergonie
Bordeaux, France
2
Centre Hospitalier de Caen
Caen, France
3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
4
Centre Hospitalier Inter. de Creteil
Créteil, France