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 risk prediction models for development of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher non-hematological immune-related adverse events (irAEs) in the first year of treatment for two cohorts of patients with solid tumors: (Cohort 1) immune checkpoint inhibitor (ICI) therapy alone and (Cohort 2) ICI therapy in combination with chemotherapy (chemo-ICI).

SECONDARY OBJECTIVES:
I. To prospectively assess the incidence of any grade of non-hematological irAEs and grade 4 hematological irAEs over 12 months. (In each treatment setting [ICI alone and chemo-ICI])
II. To observe the trajectory of patient-reported quality of life and health preferences over 12 months. (In each treatment setting [ICI alone and chemo-ICI])
III. To observe the trajectory of patient-reported adverse events over 12 months using serial assessment with select Patient-Reported Outcomes versions of the CTCAE (Patient-Reported Outcomes [PRO]-CTCAE) measures. (In each treatment setting [ICI alone and chemo-ICI])
IV. To measure the burden of chronic, grade 1 and 2 toxicities using methods such as toxicity over time (ToxT). (In each treatment setting [ICI alone and chemo-ICI])
V. To track patterns of treatment of irAEs and patterns of toxicity resolution. (In each treatment setting [ICI alone and chemo-ICI])

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

ADDITIONAL OBJECTIVES:
I. To assess the feasibility of using electronic (e)PRO in a multi-center clinical trial setting.
II. To analyze correlations between weight-based prescription or fixed dose and incidence of adverse events and immune mediated adverse events.
III. To explore associations between incidences of grade 3 or higher irAEs over 12 months and self-reported dietary fiber intake assessed with dietary screener questionnaire at baseline and at 4 weeks (+/- 2 weeks). Self-reported dietary fiber will also be correlated with stool microbiome characteristics and the CYTOX score.

OUTLINE:
Patients may undergo collection of an archived 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 and stool samples at several time points during the study.