Solid Tumor MalignanciesPREDICTONCT07192315
Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)
A study testing Bloodsampling, Pharyngeal swab sampling and Cuteanous swab sampling in people with Solid Tumor Malignancies and Solid Cancers, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (iRAE) that can be life-threatening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies, Solid Cancers
- What is being tested?
- Bloodsampling, Pharyngeal swab sampling and Cuteanous swab sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patient (≥18 years old)
- Patient presenting an histologically or cytologically confirmed solid tumour malignancy
- Patient scheduled to receive his/her first infusion of immunotherapy with anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3, alone or in combination, as part of standard care, in all validated solid oncology indications.
- Patient must have at least one measurable lesion according to RECIST 1.1 criteria
- Patient treated at AP-HM in one of the CEPCM-affiliated departments.
- Patient able to comply with study procedures and follow-up schedule
- Patient who has been informed about the study and signed the consent form
- Patient who is a beneficiary or entitled beneficiary of a social security scheme
Who cannot join
- Patient previously treated with ICIs
- Patient whose treatment plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI
- Patient included in a trial with an experimental molecule
- Patient has an active autoimmune disease or any other pathology requiring systemic corticosteroid therapy at more than 10 mg prednisone equivalent per day or any other immunosuppressive drug
- Patients with a history of organ transplantation, hematopathy or hematopoietic stem cell transplantation
- Patient with history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Patient in emergency situations, persons deprived of their liberty by judicial or administrative decision, adults subject to legal protection measures, or persons who are unable to give their consent, or pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de marseille
Marseille
Nausicaa Malissen, dr, 0491435817 ext. 33, promotion.interne@ap-hm.fr
About this study
Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (iRAE) that can be life-threatening. About 20% of patients treated with an ICI monotherapy, and up to 60% of patients treated with a combination of ICIs, experienced a severe iRAE. Most side effects are reversible if managed early, but can affect survival and quality of life, leading to treatment interruptions or hospitalization. Some of these irAEs, particularly those affecting hormonal functions, may be irreversible and persist even after treatment discontinuation.
The development of predictive biomarkers of such toxicities is an unmet medical need. The variety of mechanisms involved in iRAE, and the lack of effective animal models, could probably explain why the topic remains largely unexplored. To date, some biomarkers predictive of the occurrence of iRAE, irrespective of the type of organ affected, have been identified by state-of-the-art techniques on small cohorts prior to treatment initiation, but none is individually robust enough to be used in daily practice.
Read more
We hypothesize that a signature derived from the integrative analysis of various biological parameters (immunomonitoring, auto-immunity features, viral monitoring, microbiota monitoring, fragmentome analysis, pharmacokinetics, radiomics and genetics), available in routine hospital practice, could answer this question, and thus enable the development of specific prevention strategies
The objectives are :
Primary objective:
Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected.
Secondary objectives:
- Identify a predictive signature for severe iRAE including baseline and T1 data, irrespective of the type of organ affected.
- Identify a baseline predictive signature for organ-specific severe iRAE.
- Identify a predictive signature for organ-specific severe iRAE including baseline and T1 data.
- Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in monotherapy.
- Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in combination.
- Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for each specific immunotherapy received.
- Compare the predictive signatures between responders and non-responders according to RECIST 1.1 in order not to overlook the influence of clinical response on the variability observed.
- Describe the results obtained for each biological parameter between severe irAEs and non-severe irAEs patients.
- Describe patient-reported outcomes and quality of life parameters.
- Conditions
- Solid Tumor Malignancies, Solid Cancers
- Being tested
- Bloodsampling, Pharyngeal swab sampling, Cuteanous swab sampling, Stools sample collection
- Keywords
- immuno-induced adverse events, Immune checkpoint inhibitor, baseline predictive signature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BloodsamplingOther
Blood will be sampled At Visit 1, 2, 3 and 4. For patients presenting immuno-induced adverse events (iRAEs), an additionnal visit V tox will be planned will a blood sampling.
Pharyngeal swab samplingOther
Pharyngeal swab will be sampled at visit 4 for patients without immuno-induced adverse events (iRAEs) Pharyngeal swab will be sampled at visit Tox for patients presenting immuno-induced adverse events (iRAEs)
Cuteanous swab samplingOther
Cuteanous swab will be sampled at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs).
Cuteanous swab will be sampled at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs).
Stools sample collectionOther
Stools sample will be collected at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs).
Stools sample will be collected at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs).
| Study group | Role | What they receive |
|---|---|---|
| Blood, Throat and skin swabs and Stool additional samples | Experimental | Blood, Throat and skin swabs and Stool additional samples are collected in parallel of treatment administration throughout visits 1 to 4. Receives: Other: Bloodsampling; Other: Pharyngeal swab sampling; Other: Cuteanous swab sampling; Other: Stools sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a predictive baseline signature who maximize the rate of prediction of severe iRAE
The primary endpoint is the identification of a predictive baseline signature who maximize the rate of prediction of severe iRAE among patients who had a severe iRAE (iRAE + patients) and minimize the rate of prediction of severe iRAE among patients who had not a severe iRAE (iRAE- patients), we choose a minimum of 70% of prediction in iRAE + population and a maximum of 15% of prediction in iRAE- population.
Measured: From enrollment to the end of following after 12 months
Secondary outcomes (12)
Assesment of safety according to NCI-CTCAE v5.0 criteria
Measured: From enrollment to the end of following after 12 months
Identification of signatures for severe iRAEs
Predictive performance of baseline + T1 signatures for severe iRAEs
Measured: From enrollment to the end of following after 12 months
Identification of signatures for organ-specific severe iRAEs
Predictive performance of baseline signatures for organ-specific severe iRAEs using the same performance thresholds.
Measured: From enrollment to the end of following after 12 months
Identification of signatures for organ-specific severe iRAEs at baseline and T1
Predictive performance of baseline + T1 signatures for organ-specific severe iRAEs.
Measured: From enrollment to the end of following after 12 months
Identification of signatures for severe iRAEs in patients receiving anti-PD(L)1 monotherapy.
Performance of baseline signatures for severe iRAEs in patients receiving anti-PD(L)1 monotherapy.
Measured: From enrollment to the end of following after 12 months
Identification of signatures in patients receiving combination immunotherapy
Measured: From enrollment to the end of following after 12 months
Identification of baseline signatures for each specific immunotherapy class.
Measured: From enrollment to the end of following after 12 months
Comparison of predictive signatures between responders and non-responders (RECIST 1.1).
Measured: From enrollment to the end of following after 12 months
Rate of biological parameter variation between severe and non-severe iRAE patients
Measured: From enrollment to the end of following after 12 months
Assessment of PRO-CTCAE
NCI-PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events): which is a 81-item instruments designed to measure symptoms and side effects for patients through treatment for their cancer. Items are constructed on a 5-point Likert scale with the following response options: 1 "Not at all" / 2 "A little" / 3 "Quite a bit" / 4 "severe" / 5 "Extremely severe".
Measured: From enrollment to the end of following after 12 months
Evaluation of quality of life via EORTC QLQ-C30 questionnaire
EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, which is a 30-item instrument designed to measure quality of life in all cancer patients. 28 items are constructed on a 4-point Likert scale with the following response options: 1 "Not at all" / 2 "A little" / 3 "Quite a bit" / 4 "A lot." The last two items are constructed on a 7-point response scale.
These two items assess the patient's physical condition and overall quality of life, respectively, with response 1 corresponding to a "very poor" condition and response 7 to an "excellent".
Measured: From enrollement to the end of following after 12 months
Evaluation of quality of life via EQ-5D-5L questionnaire
EQ-5D-5L, which is descriptive system EuroQol comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scale frome 1 to 100, where 0 is the worst possible condition and 100 is the best.
Measured: From enrollement to end of the following after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start23 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192315
- Sponsor's protocol ID
- RCAPHM25_0294
- Other IDs
- 2025-A01531-48
- Acronym
- PREDICTO
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)
- ClinicalTrials.gov ID
- NCT07192315
- Acronym / sponsor ID
- PREDICTO / RCAPHM25_0294
- Conditions
- Solid Tumor Malignancies, Solid Cancers
- Keywords
- immuno-induced adverse events, Immune checkpoint inhibitor, baseline predictive signature
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 25 Sep 2025 (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.
Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (iRAE) that can be life-threatening. About 20% of patients treated with an ICI monotherapy, and up to 60% of patients treated with a combination of ICIs, experienced a severe iRAE. Most side effects are reversible if managed early, but can affect survival and quality of life, leading to treatment interruptions or hospitalization. Some of these irAEs, particularly those affecting hormonal functions, may be irreversible and persist even after treatment discontinuation.
The development of predictive biomarkers of such toxicities is an unmet medical need. The variety of mechanisms involved in iRAE, and the lack of effective animal models, could probably explain why the topic remains largely unexplored. To date, some biomarkers predictive of the occurrence of iRAE, irrespective of the type of organ affected, have been identified by state-of-the-art techniques on small cohorts prior to treatment initiation, but none is individually robust enough to be used in daily practice.
We hypothesize that a signature derived from the integrative analysis of various biological parameters (immunomonitoring, auto-immunity features, viral monitoring, microbiota monitoring, fragmentome analysis, pharmacokinetics, radiomics and genetics), available in routine hospital practice, could answer this question, and thus enable the development of specific prevention strategies
The objectives are :
Primary objective:
Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected.
Secondary objectives:
- Identify a predictive signature for severe iRAE including baseline and T1 data, irrespective of the type of organ affected.
- Identify a baseline predictive signature for organ-specific severe iRAE.
- Identify a predictive signature for organ-specific severe iRAE including baseline and T1 data.
- Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in monotherapy.
- Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in combination.
- Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for each specific immunotherapy received.
- Compare the predictive signatures between responders and non-responders according to RECIST 1.1 in order not to overlook the influence of clinical response on the variability observed.
- Describe the results obtained for each biological parameter between severe irAEs and non-severe irAEs patients.
- Describe patient-reported outcomes and quality of life parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood, Throat and skin swabs and Stool additional samples | Experimental | Other: Bloodsampling, Other: Pharyngeal swab sampling, Other: Cuteanous swab sampling, Other: Stools sample collectionBlood, Throat and skin swabs and Stool additional samples are collected in parallel of treatment administration throughout visits 1 to 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patient (≥18 years old)
- Patient presenting an histologically or cytologically confirmed solid tumour malignancy
- Patient scheduled to receive his/her first infusion of immunotherapy with anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3, alone or in combination, as part of standard care, in all validated solid oncology indications.
- Patient must have at least one measurable lesion according to RECIST 1.1 criteria
- Patient treated at AP-HM in one of the CEPCM-affiliated departments.
Key exclusion criteria (7 listed)
- Patient previously treated with ICIs
- Patient whose treatment plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI
- Patient included in a trial with an experimental molecule
- Patient has an active autoimmune disease or any other pathology requiring systemic corticosteroid therapy at more than 10 mg prednisone equivalent per day or any other immunosuppressive drug
- Patients with a history of organ transplantation, hematopathy or hematopoietic stem cell transplantation
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 |
|---|---|---|
| BloodsamplingBlood will be sampled At Visit 1, 2, 3 and 4. For patients presenting immuno-induced adverse events (iRAEs), an additionnal visit V tox will be planned will a blood sampling. | Other | Blood, Throat and skin swabs and Stool additional samples |
| Pharyngeal swab samplingPharyngeal swab will be sampled at visit 4 for patients without immuno-induced adverse events (iRAEs) Pharyngeal swab will be sampled at visit Tox for patients presenting immuno-induced adverse events (iRAEs) | Other | Blood, Throat and skin swabs and Stool additional samples |
| Cuteanous swab samplingCuteanous swab will be sampled at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs). Cuteanous swab will be sampled at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs). | Other | Blood, Throat and skin swabs and Stool additional samples |
| Stools sample collectionStools sample will be collected at visit 1, 2, 3 and 4 for patients without immuno-induced adverse events (iRAEs). Stools sample will be collected at visit 1, 2, 3 and tox for patients presenting immuno-induced adverse events (iRAEs). | Other | Blood, Throat and skin swabs and Stool additional samples |
Primary outcome
Identification of a predictive baseline signature who maximize the rate of prediction of severe iRAE
Time frame: From enrollment to the end of following after 12 months
The primary endpoint is the identification of a predictive baseline signature who maximize the rate of prediction of severe iRAE among patients who had a severe iRAE (iRAE + patients) and minimize the rate of prediction of severe iRAE among patients who had not a severe iRAE (iRAE- patients), we choose a minimum of 70% of prediction in iRAE + population and a maximum of 15% of prediction in iRAE- population.
12 secondary outcomes
Assesment of safety according to NCI-CTCAE v5.0 criteria
Time frame: From enrollment to the end of following after 12 months
Identification of signatures for severe iRAEs
Time frame: From enrollment to the end of following after 12 months
Identification of signatures for organ-specific severe iRAEs
Time frame: From enrollment to the end of following after 12 months
Identification of signatures for organ-specific severe iRAEs at baseline and T1
Time frame: From enrollment to the end of following after 12 months
Identification of signatures for severe iRAEs in patients receiving anti-PD(L)1 monotherapy.
Time frame: From enrollment to the end of following after 12 months
Identification of signatures in patients receiving combination immunotherapy
Time frame: From enrollment to the end of following after 12 months
Identification of baseline signatures for each specific immunotherapy class.
Time frame: From enrollment to the end of following after 12 months
Comparison of predictive signatures between responders and non-responders (RECIST 1.1).
Time frame: From enrollment to the end of following after 12 months
Rate of biological parameter variation between severe and non-severe iRAE patients
Time frame: From enrollment to the end of following after 12 months
Assessment of PRO-CTCAE
Time frame: From enrollment to the end of following after 12 months
Evaluation of quality of life via EORTC QLQ-C30 questionnaire
Time frame: From enrollement to the end of following after 12 months
Evaluation of quality of life via EQ-5D-5L questionnaire
Time frame: From enrollement to end of the following after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloodsampling, Pharyngeal swab sampling and Cuteanous swab sampling in people with Solid Tumor Malignancies and Solid Cancers, run by Assistance Publique Hopitaux De Marseille at 1 site 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nausicaa Malissen, dr (0491435817 ext. 33, NAUSICAA.MALISSEN@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a predictive baseline signature who maximize the rate of prediction of severe iRAE (time frame: From enrollment to the end of following after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.