Status:
UNKNOWN
Immunological Variables Associated to ICI Toxicity in Cancer Patients
Lead Sponsor:
Jules Bordet Institute
Conditions:
Breast Cancer
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 bot...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT05429866
Start Date
September 1 2022
End Date
December 1 2024
Last Update
March 8 2023
Active Locations (1)
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1
Institut Jules Bordet
Brussels, Anderlecht, Belgium, 1070