Gender Difference in sidE eFfects of ImmuNotherapy: a Possible Clue to Optimize cancEr tReatment

NCT04435964 | Completed

• 1 other identifier: INT156-19
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

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 will be a multicenter prospective observational study focusing on biological differences between females and males, possibly affecting discrepant irAEs incidence.

Conditions

Melanoma; Lung Cancer; Head and Neck Cancer; Urogenital Neoplasms; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Immune-related severe (G≥ 2) adverse events (irAEs)

  The incidence of first severe (G≥ 2) irAEs of any type will be estimated in females and males

  1 year

Secondary Outcomes (1)

• Immune-related adverse events (irAEs)

  1 year

Study Arms (1)

Overall series

Patients treated with immunocheckpoint inhibitors (ICI) irrespective of treatment schedule. No limitations to previous lines of treatment. ICI therapy may be either as single agent or in combination. Concomitant chemotherapy (CT) and radiotherapy (RT) is allowed.

Drug: Immunotherapy

Interventions

Immunotherapy DRUG

Patients treated as per clinical prescription with immunocheckpoint inhibitors (ICI) irrespective of treatment schedule, either as single agent or in combination with chemotherapy and/or radiotherapy

Also known as: Chemotherapy, Radiotherapy

Overall series

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To allow for balanced sex groups, we will include patients according to the following stratification : ICI: 100 F/100 M; ICI+ CT/RT: 100 F/100 M. Due to the current ICI use in clinical practice we are expecting to mainly populate the ICI strata during the first recruitment period. As the recruitment progresses, the sample will be enriched of ICI+CT and ICI+RT treated patients, since combinations are expanding for many cancers such for instance melanoma, lung and head and neck

You may qualify if:

• 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.

You may not qualify if:

• Patients not eligible for ICI-containing regimens.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Karolinska University Hospital: collaborator
• St Vincent's University Hospital, Ireland: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Gene-expression analysis. Blood samples will be taken in order to identify immune-related genes in patients with various solid tumors treated with ICI associated with the development of irAEs. * SNPs analysis. Blood samples will be taken in order to perform a preliminary genome wide association study for the identification of germline variations associated with the development of irAEs. with the hypothesis that the individual's genetic makeup may be related to irAEs. * Microbiome analysis. Stool collection will be performed to analyze gut microbiota aiming at performing RNA/DNA sequencing analysis for identifying components associated with the development of irAEs.

MeSH Terms

Conditions

Melanoma; Lung Neoplasms; Head and Neck Neoplasms; Urogenital Neoplasms; Breast Neoplasms

Interventions

Immunotherapy; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Breast Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Rosalba Miceli, PhD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 17, 2020
• Study Start: June 25, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 24, 2023

Record last verified: 2021-09

Locations

IT (1)