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Completed

NCT Number: NCT03447483

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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH ALBI, Albi, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Patients starting a treatment by ICI

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to appearance of toxicity

    Time frame: 12 months by patient

  2. 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

  3. Quality of life using the QLQ-C30 questionnaire

    Time frame: 12 months by patient

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: MOTIVATE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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