An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study

Study Overview
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Brief Summary
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This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Detailed Description
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PRIMARY OBJECTIVE: I. To compare incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs) between African American (AA) and European American (EA) patients within the first year of starting immune checkpoint inhibitor (ICI) treatment. SECONDARY OBJECTIVES: I. To compare objective response rate (ORR) to ICI treatment between AA and EA patients within the first year of starting ICI treatment. II. To compare health-related quality of life (HRQOL) measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Preference (Patient Reported Outcomes [PRO] Pr) summary score and Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) between AA and EA patients within 1 year of starting ICI treatment. EXPLORATORY OBJECTIVES: I. To compare AA and EA patients on severity (i.e., CTCAE grade) and timing of irAEs within 1 year of starting ICI treatment. II. To assess disease, treatment, individual, and behavioral factors as predictors of grade 2-5 irAEs, and as potential causes of racial differences in irAEs, within 1 year of starting ICI treatment. III. To compare AA and EA patients on long-term outcomes (e.g., progression-free survival [PFS], overall survival [OS], and HRQOL beyond the first year) at the end of the study period. IV. To assess the impact of irAEs and disease, treatment, behavioral, and individual factors on ICI outcomes (ORR, HRQOL, PFS, OS), and as potential causes of racial differences in outcomes, at the end of the study period. V. To compare ICI treatment patterns (e.g., delay and discontinuation of ICI treatment) between AA and EA patients within 1 year of starting ICI treatment. VI. To assess irAEs, treatment, disease, and individual factors, including healthcare barriers, as possible reasons for suboptimal treatment patterns, and as potential causes of racial differences, within 1 year of starting ICI treatment. OUTLINE: Patients complete questionnaires and undergo collection of blood and saliva samples before 1st and 2nd infusion of immunotherapy, 6 months after 1st infusion of immunotherapy, and then every year after 1st infusion of immunotherapy. Patients also undergo collection of saliva samples before 1st and 2nd infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed.

Official Title
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Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years of age or older Self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA) Patients may identify a Hispanic/Latino ethnicity in combination with an AA or EA racial identity Have a current diagnosis of invasive cancer at stage I-IV Patients may have a history of previous cancer diagnosis and cancer treatment not involving immunotherapy Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy according to Food and Drug Administration (FDA) labels or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A as standard of care treatment alone or in combination with co-treatments (including alternative ICIs) Be able to speak and read English or Spanish Be able to provide written or remote informed consent Exclusion Criteria: Identify as Asian, Pacific Islander, or American Indian/Alaskan Native Be diagnosed with melanoma (because melanoma is very rare in AAs) Currently participate or plan to participate in any other cancer treatment trials Have received prior immunotherapy for cancer, including checkpoint inhibitors, chimeric antigen receptor (CAR)-T therapy, and/or cytokine therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire, biospecimen, medical records))<br>Patients complete questionnaires and undergo collection of blood and saliva samples before 1st and 2nd infusion of immunotherapy, 6 months after 1st infusion of immunotherapy, and then every year after 1st infusion of immunotherapy. Patients also undergo collection of saliva samples before 1st and 2nd infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of immune-related adverse events (irAEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) | Rate of grade 2-5 immune-related adverse events (irAEs) will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Racial differences in irAE rates will be assessed in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests. | Within 1 year after starting immune checkpoint inhibitor (ICI) treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) to immune checkpoint inhibitors (ICIs) assessed by physician report | Overall response rate (ORR) to immune checkpoint inhibitors (ICIs) will be rated by physicians (complete response, partial response, stable disease, unconfirmed/confirmed progression, recurrence). Multivariable modeling will be conducted to adjust for covariates to establish racial differences in ORR. | Within 1 year after starting ICI treatment | 
| Health-related quality of life (HRQOL) measured using the PROMIS-Preference (PROPr) summary score | The PROMIS-Preference (PROPr) score is a summary score based on scores for Cognitive Function Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities indices from the PROMIS-29 profile. | Within 1 year after starting ICI treatment | 
| Health-related quality of life (HRQOL) measured using the Functional Assessment of Cancer Treatment - Immune Checkpoint Modulation (FACT-ICM) | The Functional Assessment of Cancer Treatment - Immune Checkpoint Modulation (FACT-ICM) contains 25 items. Participants rate severity of ICI-related symptoms on a scale from 0, not at all, to 4, very much. | Within 1 year after starting ICI treatment |