Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists (NCT03412058) | Clinical Trial Compass
TerminatedNot Applicable
Identifying the Predictive Factors of Response to PD-1 or PD-L1 Antagonists
Stopped: The study was terminated prematurely due to insufficient patient recruitment
France152 participantsStarted 2018-06-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years old.
. Histological confirmed diagnosis of one of the following:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Measurable disease according to RECIST v1.1 (Eisenhauer, 2009).
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.