Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

Conditions

• Malignant Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood sample
• Questionnaire Administration — OTHER
  Complete questionnaires

Study Details

This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.

Key Dates

Start date

Sep 13, 2021

Status verified

Feb 2026

Primary completion

Sep 30, 2026

Completion

Mar 14, 2028

Study Design

Enrollment

2,062 participants (estimated)

Arms

• Arm: Observational (biospecimen collection, questionnaire)
  Patients undergo collection of a tissue sample at the start of their routine cancer treatment. Patients complete questionnaires at the start of cancer treatment, weeks 4, 12, 24, and 52. Patients will have the option of providing blood samples at several time points during the study.

Primary Outcome Measure

Occurrence of severe or worse non-hematological immune-related adverse event (irAE) [ Time Frame: 52 weeks ]

Locations (843)