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

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.

VII. To collect optional stool samples and an additional blood sample at the time of the occurrence of grade 3-4 irAEs to strengthen the biobank for future research on ICI response and racial disparities.

OUTLINE: This is an observational study.

Patients complete questionnaires and undergo collection of blood, saliva, and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.

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 alone or in combination with co-treatments (including alternative ICIs)
• Be able to speak and read English or Spanish
• Be able to provide 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 in any trials of a cancer therapeutic nature; participation in noninterventional trial, or trials of symptom control or supportive nature is allowed; participation in future cancer therapeutic trials after completing the A2 assessment (e.g., after the second infusion of ICIs) is also allowed
• Have received prior immunotherapy for cancer, including checkpoint inhibitors, chimeric antigen receptor (CAR)-T therapy, cytokine therapy, and/or Bacillus Calmette-Guerin (BCG) for bladder cancer