Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy (MINER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514368
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:

This trial is a translational, open-label, multi-site, prospective cohort study of 440 patients aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.

The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.

Patients with any of the following tumor types may be enrolled in the trial:

  • Non-Small Cell Lung Cancer (NSCLC),
  • Head and neck cancer,
  • Melanoma,
  • Bladder cancer,
  • Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.

For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.

All included patients will be followed-up until progression. After this date, survival data will be collected.


Condition or disease Intervention/treatment Phase
Solid Cancers Other: Patients treated with immune checkpoint blockade Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Arm Intervention/treatment
Patients treated with immune checkpoint blockade Other: Patients treated with immune checkpoint blockade

Tumor biopsy specimens and blood samples will be collected at different time points:

  • Baseline
  • before the 3rd ICB administration (blood samples only)
  • before the 5th ICB administration (blood samples only)
  • at the time of treatment permanent discontinuation (blood samples only)
  • at the time of progression (tumor biopsy specimens only)
  • after the last dose of ICB treatment (blood samples only taken twice per year until study termination)




Primary Outcome Measures :
  1. Rate of objective response (complete or partial response) [ Time Frame: 18 months by patient ]
    Response will be assessed according to RECIST 1.1 / investigator judgment


Secondary Outcome Measures :
  1. Progression Free Survival defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first. [ Time Frame: 18 months by patient ]
  2. Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria [ Time Frame: 18 months by patient ]
  3. Immune related adverse event (irAE) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 [ Time Frame: 12 months by patient ]


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.


Layout table for eligibility information
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 at the time of study entry.
  2. Patient with histologically documented metastatic and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).
  3. Patient for which a treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination has been decided.
  4. Archived frozen tumor specimen available or feasible for pre-treatment tumor biopsy.
  5. Current treatment with ICB not yet started.
  6. Evaluable disease (measurable as per RECIST 1.1. or not).
  7. ECOG Performance status 0-2.
  8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
  9. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

  1. Patient pregnant, or breast-feeding.
  2. Uveal melanoma
  3. Any condition contraindicated with tumor /blood sampling procedures required by the protocol.
  4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.
  6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
  7. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

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): NCT03514368


Contacts
Layout table for location contacts
Contact: Jean-Pierre DELORD, MD 05 31 15 55 00 delord.jean-pierre@iuct-oncopole.fr

Locations
Layout table for location information
France
Hopital Larrey Recruiting
Toulouse, France, 31059
Contact: Julien MAZIERES, MD    05 67 77 18 37    mazieres.j@chu-toulouse.fr   
Institut Universitaire Du Cancer de Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Jean-Pierre DELORD, MD    05 31 15 55 00    delord.jean-pierre@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud

Layout table for additonal information
Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03514368     History of Changes
Other Study ID Numbers: 17 GENE 23
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Immune checkpoint modulation
Tumor antigens
Adaptive immune responses
Tumor molecular signature