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

Not Applicable

Completed

• Conditions: Solid Tumor
• Interventions: Other: Patients starting a treatment by ICI

• Registration Number: NCT03447483
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-27
• Study Start: 2018-04-20
• Primary Completion: 2020-06-18
• Study Completion: 2020-06-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort of patients starting a treatment by ICI	Patients starting a treatment by ICI	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Institut Regional Du Cancer de Montpellier (Icm); 🇫🇷 Montpellier, France

Institut Universitaire Du Cancer de Toulouse - Oncopole; 🇫🇷 Toulouse, France

CH ALBI; 🇫🇷 Albi, France

Ch Castres; 🇫🇷 Castres, France

Hopital Larrey; 🇫🇷 Toulouse, France

Institut Curie; 🇫🇷 Paris, France