Clinical trial NCT03447483: Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).
Official title: Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor
Keywords: Solid tumor
Immune Checkpoint Inhibitor
immune-related Adverse Event
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
timeFrame: 12 months by patient
Secondary outcomes:
measure: Time to appearance of toxicity
timeFrame: 12 months by patient
measure: Rate of patients for which treatment was restarted among those who had stopped treatment for the management of an immune-related Adverse Event (irAE)
timeFrame: 12 months by patient
measure: Quality of life using the QLQ-C30 questionnaire
timeFrame: 12 months by patient
Other outcomes:
Locations:
city: Albi
country: France
facility: CH ALBI
city: Castres
country: France
facility: Ch Castres
city: Montpellier
country: France
facility: Institut Regional Du Cancer de Montpellier (Icm)
city: Paris
country: France
facility: Institut Curie
city: Toulouse
country: France
facility: Hopital Larrey
city: Toulouse
country: France
facility: Institut Universitaire Du Cancer de Toulouse - Oncopole
Study officials:
References:
citation: Cabarrou B, Gomez-Roca C, Viala M, Rabeau A, Paulon R, Loirat D, Munsch N, Delord JP, Filleron T. Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial. Invest New Drugs. 2020 Dec;38(6):1879-1887. doi: 10.1007/s10637-020-00938-x. Epub 2020 May 7.