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)


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


University of Rochester Cancer Center


Gibbs Cancer Center
2759 Hwy 14 South
Greer, SC 29650

AnMed Cancer Center
2000 E. Greenville St.
Suite 5130
Anderson, SC 29621

St. Francis Cancer Center
104 Innovation Dr.
Greenville, SC 29607