Breast CancerPhase 2NCT05429866
Immunological Variables Associated to ICI Toxicity in Cancer Patients
A Phase 2 study testing Checkpoint Blockade, Immune in people with Breast Cancer and Melanoma, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Melanoma, Non Small Cell Lung Cancer
- What is being tested?
- Checkpoint Blockade, Immune
- How many people
- 441 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2022to 1 Dec 2024
- Phase
- Phase 2
- 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
- 1) Age ≥ 18 years old
- 2) ECOG performance status ≤ 1
- 3) Must have histologically or cytologically confirmed solid tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies
- 4) All prior anti-cancer treatment-related toxicities (except alopecia) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment
- 5) Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration.
- 6) Women of childbearing potential must agree to use one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatments.
Show all 9Show fewer
- 7) Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatments.
- 8) Completion of all necessary screening procedures within 14 days prior to enrolment.
- 9) Signed Informed Consent form (ICF) obtained prior to any study related procedure.
Who cannot join
- Subjects meeting one of the following criteria are not eligible for this study:
- Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
- Participation in another clinical trial.
- Pregnant and/or lactating women.
- Subjects already receiving ICI.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, Anderlecht, 1070
MIREILLE LANGOUO, MD, PhD, 0032(2)5413377, mireille.langouo@bordet.be
About this study
This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.
For enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points:
- Early (4-6 weeks after treatment start)
- Midtime (8-11 weeks after treatment start)
- Late (13-18 weeks after treatment start)
- At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points:
- For the 1st time of any grade 1 or 2 irAE if the subject developed it.
- For the 1st time of any grade 3 or 4 irAE if the subject developed it.
Read the detailed description
Advances in treating patients with immunotherapy has dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other drugs, are currently used both as standard of care or in experimental settings for various cancers. Currently, ICI treatment induces objective clinical responses in 20-40% of patients, which varies by tumour type. A significant risk of immune-related adverse events (irAE) is also associated with ICI treatment, including the onset of autoimmune diseases. While the incidence of irAE is highly variable and influenced by many factors, phase I and II trials reported rates from 10% to 80% for any grade irAE while an irAE of grade 3 or higher was observed in 2.5% to 18% of subjects. Despite the fact that older adults represent the growing majority of patients diagnosed with cancer, the efficacy and toxicity of ICI in older patients, alone or in combination with other agents, remains controversial. Presently, the specific immune mechanism(s) driving irAE are unknown and biomarkers that predict their onset, particularly high-grade irAE, are urgently needed. The identification of predictive clinical, laboratory and immunological biomarkers (blood and tissue) for toxicity will more accurately identify and quantify patients who are at risk for ICI therapy. Then, this will possibly allow better irAE management.
- Conditions
- Breast Cancer, Melanoma, Non Small Cell Lung Cancer, Non-melanoma Skin Cancer, Gastrointestinal Cancer, Head and Neck Cancer
- Being tested
- Checkpoint Blockade, Immune
- Medical subject headings
- Breast Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms, Head and Neck Neoplasms, Carcinoma, Renal Cell, Small Cell Lung Carcinoma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checkpoint Blockade, ImmuneDrug
Also called Ipililumab, Nivolumab, Pembrozilumab, atezolizumab
Immune checkpoint blockade drugs target the immune system by blocking control pathways regulating anti-tumor immunity and thereby reinvigorate their activities against cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification(s) in the immune blood markers of treated subjects on treatment.
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Measured: Assessment: between week 4 and 6 after the first dose of the treatment
Modification(s) in the immune blood markers of treated subjects on treatment.
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Measured: Assessment: between week 8 and 11 after the first dose of the treatment
Modification(s) in the immune blood markers of treated subjects on treatment.
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Measured: Assessment: between week 13-18 after the first dose of the treatment
Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 1 or 2 irAE.
Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: Assessment: Day1 after diagnostic of any grade 1 or 2 irAE
Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 3 or 4 irAE.
Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: Assessment: Day one after diagnostic of any grade 3 or 4 irAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.
- Masking
- None (open label)
- Enrolment
- 441 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireille Langouo Fontsa, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429866
- Sponsor's protocol ID
- IJB-IRAES-2020
- Status last verified
- Mar 2023
- First submitted
- 24 Apr 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Variables Associated to ICI Toxicity in Cancer Patients
- ClinicalTrials.gov ID
- NCT05429866
- Acronym / sponsor ID
- IJB-IRAES-2020
- Conditions
- Breast Cancer, Melanoma, Non Small Cell Lung Cancer, Non-melanoma Skin Cancer, Gastrointestinal Cancer, Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 441 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 Jun 2022 (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 is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.
For enrolled subjects, clinical and laboratory evaluations will be performed and reported at different time points:
- Early (4-6 weeks after treatment start)
- Midtime (8-11 weeks after treatment start)
- Late (13-18 weeks after treatment start)
- At the occurrence of immune-related adverse events (irAEs), clinical and laboratory evaluation will be performed at two principal time points:
- For the 1st time of any grade 1 or 2 irAE if the subject developed it.
- For the 1st time of any grade 3 or 4 irAE if the subject developed it.
Detailed description
Advances in treating patients with immunotherapy has dramatically changed cancer morbidity and mortality. Immune checkpoint inhibitors (ICI), alone or combined with other drugs, are currently used both as standard of care or in experimental settings for various cancers. Currently, ICI treatment induces objective clinical responses in 20-40% of patients, which varies by tumour type. A significant risk of immune-related adverse events (irAE) is also associated with ICI treatment, including the onset of autoimmune diseases. While the incidence of irAE is highly variable and influenced by many factors, phase I and II trials reported rates from 10% to 80% for any grade irAE while an irAE of grade 3 or higher was observed in 2.5% to 18% of subjects. Despite the fact that older adults represent the growing majority of patients diagnosed with cancer, the efficacy and toxicity of ICI in older patients, alone or in combination with other agents, remains controversial. Presently, the specific immune mechanism(s) driving irAE are unknown and biomarkers that predict their onset, particularly high-grade irAE, are urgently needed. The identification of predictive clinical, laboratory and immunological biomarkers (blood and tissue) for toxicity will more accurately identify and quantify patients who are at risk for ICI therapy. Then, this will possibly allow better irAE management.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This is a monocentric, prospective, pilot study that will enrol 435 subjects with solid tumours that are treated with immune checkpoint inhibitor(s) (ICI) alone or in combination with chemotherapy or targeted therapy.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1) Age ≥ 18 years old
- 2) ECOG performance status ≤ 1
- 3) Must have histologically or cytologically confirmed solid tumour, eligible for treatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies
- 4) All prior anti-cancer treatment-related toxicities (except alopecia) must be ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment
- 5) Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration.
Key exclusion criteria (5 listed)
- Subjects meeting one of the following criteria are not eligible for this study:
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 |
|---|---|---|
| Checkpoint Blockade, ImmuneAlso: Ipililumab, Nivolumab, Pembrozilumab, atezolizumabImmune checkpoint blockade drugs target the immune system by blocking control pathways regulating anti-tumor immunity and thereby reinvigorate their activities against cancer. | Drug | – |
Primary outcome
Modification(s) in the immune blood markers of treated subjects on treatment.
Time frame: Assessment: between week 4 and 6 after the first dose of the treatment
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Modification(s) in the immune blood markers of treated subjects on treatment.
Time frame: Assessment: between week 8 and 11 after the first dose of the treatment
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Modification(s) in the immune blood markers of treated subjects on treatment.
Time frame: Assessment: between week 13-18 after the first dose of the treatment
Modification(s) in the immune blood markers including cytokines, immune cells and serum autoantibody level of treated subjects.
Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 1 or 2 irAE.
Time frame: Assessment: Day1 after diagnostic of any grade 1 or 2 irAE
Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Modification(s) in the immune blood markers of treated subjects on treatment at the occurence of any grade 3 or 4 irAE.
Time frame: Assessment: Day one after diagnostic of any grade 3 or 4 irAE
Safety will be assessed and graded by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Checkpoint Blockade, Immune in people with Breast Cancer and Melanoma, run by Jules Bordet Institute at 1 site in Belgium.
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 9 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mireille Langouo Fontsa, MD (0032 (0) 484729928, mireille.langouo@bordet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modification(s) in the immune blood markers of treated subjects on treatment. (time frame: Assessment: between week 4 and 6 after the first dose of the treatment). The study lists 5 primary outcomes in all. 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 8 Mar 2023.