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

Solid Tumor Clinical Trial

— MOTIVATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447483
• Other study ID #: 17GENE22
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: June 18, 2020

Study information

• Verified date: January 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
France	CH ALBI	Albi
France	Ch Castres	Castres
France	Institut Regional Du Cancer de Montpellier (Icm)	Montpellier
France	Institut Curie	Paris
France	Hopital Larrey	Toulouse
France	Institut Universitaire Du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to appearance of toxicity		12 months by patient
Secondary	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
Secondary	Quality of life using the QLQ-C30 questionnaire		12 months by patient