The Gut Immune System During Immune Checkpoint Inhibitor Therapy (DEFENCE)

University Medical Center Groningen (UMCG)

Status: Active, not recruiting

Conditions: Cancer

Treatments: Procedure: sigmoidoscopies and and venous blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04600180

202000666

Details and patient eligibility

About

This exploratory study aims to gain insight in gut immune system phenotypes before and after immunotherapy. After informed consent is obtained, sigmoidoscopies at baseline and during treatment with immunotherapy will be performed, During the endoscopies, biopsies from the sigmoid and rectum will be obtained. Subsequent immune cell analyses in these biopsies will be performed. Parallel to the sigmoidoscopies, venous blood samples will be obtained to monitor inflammatory markers.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for treatment with anti PD1/PDL1 based immunotherapy
• Written informed consent
• Evaluable according to iRECIST v1.1

Exclusion criteria

• Concomitant, chronic or infectious illness in the past 6 months causing moderate to severe colitis
• Use of a medication in the past 6 months with an elevated risk of moderate to severe colitis
• Gastrointestinal resection or enterostomy
• Abdominal radiotherapy in the past 6 months

Trial design

38 participants in 1 patient group

Palliative treatment with immunotherapy

Treatment:

Procedure: sigmoidoscopies and and venous blood sampling