Clinical trial · Interventional
Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients starting a treatment by ICI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cohort of patients starting a treatment by ICI
- interventionNames
- Other: Patients starting a treatment by ICI
Primary outcomes (1)
- 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 (3)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDCabarrou 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. PMID 32383099
- RESULTMorisseau M, Gomez-Roca C, Viala M, Rabeau A, Loirat D, Munsch N, Thomas K, Pages C, Korakis I, Sibaud V, Delord JP, Filleron T, Cabarrou B. Modernizing the assessment and reporting of adverse events in oncology clinical trials using complementary statistical approaches: a case study of the MOTIVATE trial. Invest New Drugs. 2024 Dec;42(6):664-674. doi: 10.1007/s10637-024-01481-9. Epub 2024 Nov 4. PMID 39495388