Status:
COMPLETED
Gender Difference in sidE eFfects of ImmuNotherapy: a Possible Clue to Optimize cancEr tReatment
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborating Sponsors:
Karolinska University Hospital
St Vincent's University Hospital, Ireland
Conditions:
Melanoma
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The study aim is to investigate the differences between sex and gender in the immune-related adverse events (irAEs) development associated with immune checkpoint inhibitors (ICI) treatment. The study ...
Detailed Description
The study aim is to investigate the differences between sex and gender in the immune-related adverse events (irAEs) development associated with immune checkpoint inhibitors (ICI) treatment. In common...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Histologically confirmed diagnosis of one of the following cancers: melanoma, lung, head and neck, urogenital, breast cancer. In addition, other solid tumors characterized by the presence of microsatellite instability (MSI-high), treated with immunocheckpoint inhibitors (ICI) irrespective of treatment schedule. It is possible to include patients treated with Immunotherapy in a compassionate use setting.
- Any disease stage.
- Patients eligible for immune checkpoint inhibitors (ICI)-containing regimens: ICI single agent; Combination of ICIs; ICI-chemotherapy combination; ICI-radiotherapy combination.
- Any treatment setting (neoadjuvant, adjuvant, advanced disease, maintenance).
- Patient age ≥18 years
- ECOG Performance Status of 0-2.
- Adequate bone marrow, liver and renal function.
- Life expectancy of at least 12 weeks.
Exclusion
- Patients not eligible for ICI-containing regimens.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT04435964
Start Date
June 25 2020
End Date
February 28 2023
Last Update
March 24 2023
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133