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Immunological variables associated to ICI toxicity in cancer patients
EU CTIS ID: 2023-505360-11-00
What this study is testing
The main objective of this pilot study is to explore the value of immune markers present in blood in the purpose of identifying biomarkers for immune-related toxicities of checkpoint inhibitors.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years old
- ECOG performance status ≤ 1
- Must have histologically or cytologically confirmed solid tumour, eligible fortreatment 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
- 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
- Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration
- 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
You likely can't join if
- 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
- Patients already receiving ICI
See the full eligibility criteria
- Age ≥ 18 years old
- ECOG performance status ≤ 1
- Must have histologically or cytologically confirmed solid tumour, eligible fortreatment 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
- 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
- Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration
- 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
- 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
- Completion of all necessary screening procedures within 14 days prior to enrolment
- Signed Informed Consent form (ICF) obtained prior to any study related procedure
- 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
- Patients already receiving ICI
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.