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MelanomaCHECK'UPNCT03412058

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

A study testing Biopsy in people with Melanoma and Non Small Cell Lung Cancer, run by UNICANCER at 19 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
19 sitesFrance
Study dates
27 Jun 2018to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • Institut Bergonie

    Bordeaux

  • Centre Hospitalier de Caen

    Caen

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Hospitalier Inter. de Creteil

    Créteil

  • Centre Georges François Leclerc

    Dijon

  • Centre Oscar lambret

    Lille

  • Centre Léon Bérard

    Lyon

  • Institut Régional du Cancer de Montpellier

    Montpellier

  • Institut de cancérologie de l'ouest

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • Institut Curie

    Paris

  • Institut Jean Godinot

    Reims

  • Centre Eugène Marquis

    Rennes

  • Institut Curie - Hôpital René Huguenin

    Saint-Cloud

  • CHU Saint-Etienne, Hôpital Nord

    Saint-Etienne

  • Institut Claudius Regaud - IUCT- 0

    Toulouse

  • CHU de Tours

    Tours

  • Institut Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

  • Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Prospective Cohort Study to Identify the Predictive Factors of Response to PD-1 or PD-L1 Antagonists

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.

Read the 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.

Being tested
Biopsy
Keywords
PD-1, PD-L1
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiopsyProcedure or surgery

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

  • BiopsyProcedure or surgery

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

  • BiopsyProcedure or surgery

    To be performed at disease progression if medically feasible

Study groups in NCT03412058
Study groupRoleWhat they receive
MelanomaExperimentalBiopsy 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
Receives: Procedure: Biopsy
NSCLCExperimentalBiopsy 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
Receives: Procedure: Biopsy
HNSCCExperimentalBiopsy 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
Receives: Procedure: Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 84 days

Secondary outcomes (9)

  1. Frequency and severity of adverse events occuring during the observation period

    Adverse events will be evaluated according to NCI-CTCAE v4

    Measured: Through treatment period

  2. Objective response

    Objective response as assessed by Investigators according to RECIST v1.1.

    Measured: 84 days

  3. Objective response

    Objective response as assessed centrally according to RECIST v1.1.

    Measured: 84 days

  4. Progression-free survival

    defined as the time from inclusion until documented disease progression (PD) according to RECIST v1.1, or death, whichever occurs first.

    Measured: 5 years

  5. iProgression-free survival

    defined as the time from inclusion until documented PD according to iRECIST or death, whichever occurs first.

    Measured: 5 years

  6. Overall survival

    defined as the time from inclusion until death due to any cause.

    Measured: 5 years

  7. Duration of response

    defined as the time from first observation of objective response according to RECIST v.1.1 until PD or death, whichever occurs first

    Measured: 5 years

  8. Treatment costs

    including cost of antiPD-1/PD-L1 treatment and supportive care for antiPD-1/PD-L1 treatment-related adverse events

    Measured: 5 years

  9. Tumour size

    Changes in tumour size over time

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2018
  2. Study start27 Jun 2018
  3. Primary completion2 Jan 2024
  4. Study completion1 Dec 2025

Why it stopped: The study was terminated prematurely due to insufficient patient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03412058
Sponsor's protocol ID
UC-0108/1708
Acronym
CHECK'UP
Status last verified
Jul 2026
First submitted
14 Nov 2017
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biopsy in people with Melanoma and Non Small Cell Lung Cancer, run by UNICANCER at 19 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was terminated prematurely due to insufficient patient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of response signature (time frame: 84 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03412058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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