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Comparing cancer treatment outcomes between African American and European American patients on immune checkpoint inhibitors

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

University of Rochester · NCT05364086

This study looks at how cancer treatment outcomes differ between African American and European American patients using immune checkpoint inhibitors to see if there are any racial disparities in side effects and overall health after treatment.

Quick facts

Study typeObservational
Enrollment2100 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Rochester (other)
Drugs / interventionschimeric antigen receptor, immunotherapy
Locations259 sites (Jonesboro, Arkansas and 258 other locations)
Trial IDNCT05364086 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare treatment outcomes between African American/Black (AA) and European American/White (EA) patients receiving immune checkpoint inhibitors (ICIs) for cancer. It will collect blood and saliva samples, along with health and treatment information, to analyze differences in immune-related adverse events (irAEs), objective response rates, and health-related quality of life within the first year of treatment. The study also seeks to identify factors that may contribute to racial disparities in treatment outcomes and long-term survival rates. By focusing on a racially diverse patient population, the study hopes to enhance understanding of healthcare disparities in cancer treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who self-identify as African American/Black or European American/White and are scheduled to receive immune checkpoint inhibitor therapy for invasive cancer.

Not a fit: Patients who identify as Asian, Pacific Islander, or American Indian/Alaskan Native, or those diagnosed with melanoma, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for racially diverse cancer patients receiving immune checkpoint inhibitors.

How similar studies have performed: While this study addresses a specific racial comparison in cancer treatment, similar studies have shown success in identifying disparities in treatment outcomes among different racial groups.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Jonesboro, Arkansas and 258 other locations

+209 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.