NCT03447483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

February 21, 2018

Last Update Submit

April 9, 2026

Conditions

Solid Tumor

Keywords

Solid tumorImmune Checkpoint Inhibitorimmune-related Adverse Event

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time to appearance of toxicity

    12 months by patient

  • 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

Study Arms (1)

Cohort of patients starting a treatment by ICI

OTHER
Other: Patients starting a treatment by ICI

Interventions

Patients starting a treatment by ICIOTHER

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

Cohort of patients starting a treatment by ICI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years old
  • Patient with a solid tumor whatever the organ
  • Patient receiving an Immune Checkpoint Inhibitor treatment
  • Patient starting first cycle of Immune Checkpoint Inhibitor treatment whatever the treatment line
  • Patient affiliated to the french social security system

You may not qualify if:

  • Patient who must receive a treatment other than Immune Checkpoint Inhibitor
  • Patient with contraindication to the use of a checkpoint inhibitor (e.g., auto immune disorders requiring an immunosuppressive therapy)
  • Pregnant or breastfeeding women
  • Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  • Patient protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CH ALBI

Albi, France

Location

Ch Castres

Castres, France

Location

Institut Regional Du Cancer de Montpellier (Icm)

Montpellier, 34298, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Larrey

Toulouse, 31059, France

Location

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Location

Related Publications (2)

  • 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.

    PMID: 32383099BACKGROUND

  • Morisseau 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: 39495388RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 27, 2018

Study Start

April 20, 2018

Primary Completion

June 18, 2020

Study Completion

June 18, 2020

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

FR(6)