ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)

Indiana University

Status: Begins enrollment in 2 months

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06900296

PHARM-IUSCCC-0913

Details and patient eligibility

About

This is a prospective observational study that will collect blood samples at 1-10 timepoints related to initiation of immunotherapy. The study may collect samples before the start of immunotherapy and/or at clinically significant timepoints during immunotherapy treatment.

Full description

The long-term goal of this research is to identify immunologic and other blood-borne markers of immunotherapy efficacy and toxicity. The objective of this proposal is to identify associations between immunologic parameters and other blood-borne markers with treatment response, irAE development, or relevant biomarkers of both outcomes.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years old at the time of informed consent.
2. Have a diagnosis of cancer and initiating therapy with single agent or combination therapy that includes an immunotherapy (see Appendix 16.1 for list of immunotherapy classes).
3. Ability to provide written informed consent and HIPAA authorization.

Exclusion criteria

1. Not meeting any of the previously described inclusion criteria.