Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/antiPD-L1 Immunotherapy in a Community Oncology Setting (URCC-21038)

Overview

This is a Prospective Observational Cohort Study, designed specifically to investigate racial differences in toxicities and treatment outcomes of cancer patients treated with immune checkpoint inhibitors (ICIs). ICIs are a powerful and innovative mode of cancer therapy. Their use has increased dramatically over the past 5 years. However, little data has been collected about ICI treatment response among patients of African ancestry (AA). In addition, little is known about the toxicities, treatment patterns, long-term outcomes, and post-treatment quality of life associated with ICIs outside the clinical trials setting. A prospective cohort study with a focus on this real-world question of racial differences between AA patients and patients of European ancestry (EA) in real-world community oncology
settings could address these knowledge gaps.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

• 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 FDA labels or
  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

Key Exclusion Criteria

A patient will not be eligible for this trial if any of the following criteria apply.

• 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, CAR-T therapy, and/or cytokine therapy

Sponsor(s)

University of Rochester Cancer Center