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NCORP Trials

Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors

Status
Active
Cancer Type
Solid Tumor
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCD ID
NCT04871542
Protocol IDs
S2013 (primary)
S2013
S2013
NCI-2021-01262
Study Sponsor
SWOG
NCI Full Details
http://clinicaltrials.gov/show/NCT04871542

Summary

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.

Objectives

PRIMARY OBJECTIVE:
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.

SECONDARY OBJECTIVES:
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.

TRANSLATIONAL MEDICINE OBJECTIVES:
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.

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

OUTLINE:
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.
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