An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study
Hematopoietic Malignancies
Solid Tumor
18 Years and older, Male and Female
URCC21038 (primary)
URCC-21038
URCC-21038
NCI-2022-01426
Summary
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.
Objectives
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.
Eligibility
- 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
Treatment Sites in Georgia
1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com
1831 Fifth Avenue
Columbus, GA 31904
706-780-6201
2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org
960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342
404-303-3355
www.ugynonc.com
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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