Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE). (MOTIVATE)

April 9, 2026 updated by: Institut Claudius Regaud

This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.

The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

The study data (immune-related adverse events) will be collected during each administration of the treatment.

A questionnaire will be completed by the patient before the treatment administrations.

Patients will be followed until disease progression or up to 12 months of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albi, France
        • CH ALBI
      • Castres, France
        • Ch Castres
      • Montpellier, France, 34298
        • Institut Regional Du Cancer de Montpellier (Icm)
      • Paris, France, 75005
        • Institut Curie
      • Toulouse, France, 31059
        • Hôpital Larrey
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer de Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > or = 18 years old
  2. Patient with a solid tumor whatever the organ
  3. Patient receiving an Immune Checkpoint Inhibitor treatment
  4. Patient starting first cycle of Immune Checkpoint Inhibitor treatment whatever the treatment line
  5. Patient affiliated to the french social security system
  6. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure

Exclusion Criteria:

  1. Patient who must receive a treatment other than Immune Checkpoint Inhibitor
  2. Patient with contraindication to the use of a checkpoint inhibitor (e.g., auto immune disorders requiring an immunosuppressive therapy)
  3. Pregnant or breastfeeding women
  4. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  5. Patient protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort of patients starting a treatment by ICI
Other: Patients starting a treatment by ICI

Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30) before treatment administration and during the 12 months of treatment period, at the following time points:

  • every 6 weeks for treatment regimen administered every 2 or 3 weeks
  • at Weeks 6, 12, 20, 24 for treatment regimen administered every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Time Frame: 12 months by patient
12 months by patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to appearance of toxicity
Time Frame: 12 months by patient
12 months by patient
Rate of patients for which treatment was restarted among those who had stopped treatment for the management of an immune-related Adverse Event (irAE)
Time Frame: 12 months by patient
12 months by patient
Quality of life using the QLQ-C30 questionnaire
Time Frame: 12 months by patient
12 months by patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

June 18, 2020

Study Completion (Actual)

June 18, 2020

Study Registration Dates

First Submitted

February 21, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17GENE22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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