Solid TumorMOTIVATENCT03447483
Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).
A study testing Patients starting a treatment by ICI in people with Solid Tumor, run by Institut Claudius Regaud at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Patients starting a treatment by ICI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesFrance
- Study dates
- 20 Apr 2018to 18 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH ALBI
Albi
Ch Castres
Castres
Institut Regional Du Cancer de Montpellier (Icm)
Montpellier, 34298
Institut Curie
Paris, 75005
Hopital Larrey
Toulouse, 31059
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
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.
Read more
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
- Being tested
- Patients starting a treatment by ICI
- Keywords
- Solid tumor, Immune Checkpoint Inhibitor, immune-related Adverse Event
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort of patients starting a treatment by ICI | Other | Not described Receives: Other: Patients starting a treatment by ICI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Measured: 12 months by patient
Secondary outcomes (3)
Time to appearance of toxicity
Measured: 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)
Measured: 12 months by patient
Quality of life using the QLQ-C30 questionnaire
Measured: 12 months by patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start20 Apr 2018
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447483
- Sponsor's protocol ID
- 17GENE22
- Acronym
- MOTIVATE
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2018
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32383099Morisseau 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.
PubMed 39495388
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).
- ClinicalTrials.gov ID
- NCT03447483
- Acronym / sponsor ID
- MOTIVATE / 17GENE22
- Conditions
- Solid Tumor
- Keywords
- Solid tumor, Immune Checkpoint Inhibitor, immune-related Adverse Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients starting a treatment by ICI | Other | Other: Patients starting a treatment by ICI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients starting a treatment by ICICompletion 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 | Other | Cohort of patients starting a treatment by ICI |
Primary outcome
Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
Time frame: 12 months by patient
3 secondary outcomes
Time to appearance of toxicity
Time frame: 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)
Time frame: 12 months by patient
Quality of life using the QLQ-C30 questionnaire
Time frame: 12 months by patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 32383099Cabarrou 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.
- Results publication: PubMed 39495388Morisseau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients starting a treatment by ICI in people with Solid Tumor, run by Institut Claudius Regaud at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of toxicities evaluated according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03 (time frame: 12 months by patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447483, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.