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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

Active: Yes
Cancer Type: Solid Tumor NCT ID: NCT04871542
Trial Phases: Protocol IDs: S2013 (primary)
Eligibility: 18 Years and older, Male and Female Study Type: Other
Study Sponsor: SWOG
NCI Full 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.


I. To both develop and independently validate a risk prediction model for Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of immune checkpoint inhibitor (ICI)-based therapy for the treatment of solid tumors.

I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs on ICI-based therapy.
II. To observe the trajectory of patient-reported quality of life and health preferences over 12 months.
III. To observe the trajectory of patient-reported adverse events over 12 months using serial assessment with select Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures.
IV. To measure the burden of chronic, grade 1 and 2 toxicities using methods such as toxicity over time (ToxT).
V. To track patterns of treatment of irAEs and patterns of toxicity resolution.

I. To evaluate the cytokine toxicity (CYTOX) score, a composite measure derived from 11 different cytokine levels, both prior to ICI-based therapy and after 1 cycle of ICI-based therapy as a predictive signature for the development of irAEs.
II. To establish a repository of archival tissue and blood/serum specimens for potential predictive and/or prognostic markers of irAE risk.

I. To assess the feasibility of using electronic (e)PRO in a multi-center clinical trial setting.

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.

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.