NCT03447483

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-04-20
• Primary completion: 2020-06-18
• Completion: 2020-06-18
• First posted: 2018-02-27
• Last updated: 2026-04-14

Locations

6 sites across 1 country: France