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

Malignant Solid Neoplasm Clinical Trial

— DiRECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364086
• Other study ID #: URCC21038
• Secondary ID: NCI-2022-01426UR
• Status: Recruiting
• Start date: April 26, 2022
• Est. completion date: May 31, 2027

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: Micalah Klejment
• Phone: 585-273-2547
• Email: URCC_21038[@]urmc.rochseter.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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, saliva, stool, and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand healthcare disparities among all cancer patients.

Description:

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 will complete questionnaires and undergo collection of blood, saliva, and stool (optional) samples before the 1st and 2nd infusion of immunotherapy. Blood samples will be collected 6 months after 1st infusion of immunotherapy, and then every year after 1st infusion of immunotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 written or remote 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 non-interventional 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, CAR-T therapy, cytokine therapy, and/or Bacillus Calmette-Guerin (BCG) for bladder cancer

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Locations

Country	Name	City	State
United States	Saint Anthony's Health	Alton	Illinois
United States	SIH Cancer Institute	Carterville	Illinois
United States	Central Care Cancer Center - Garden City	Garden City	Kansas
United States	Capital Region Southwest Campus	Jefferson City	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Springfield Clinic	Springfield	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester NCORP Research Base	National Cancer Institute (NCI), Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity and timing of immune-related adverse events (irAEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE)	Severity and timing of grade 2-5 immune-related adverse events (irAEs) will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Racial differences in irAE rates will be assessed in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.	Within 1 year after starting ICI treatment
Other	Progression-free survival	Two sample t-test or Wilcoxon rank test will be conducted for continuous outcomes. Log-rank test will be used to evaluate between group (AA versus [vs.] AE) for time-dependent variables. Multivariable Cox regression will be conducted to adjust for imbalance in covariates.	Up to 4 years
Other	Health related quality of life (HRQOL) since ICI treatment at the end of the study periodHealth-related quality of life (HRQOL) measured using the PROMIS-Preference (PROPr) summary score at the end of the study period	Will be examined at the end of the study period (up to 4 years) using a two sample t-test to compare racial groups.	Up to 4 years
Other	Treatment delay and discontinuation	Treatment delay is defined as time lapse between two consecutive infusion cycles >4 weeks (yes/no), and discontinuation as permanently holding further administration of ICI immunotherapy due to toxicities or disease progression in the metastatic setting, or total infusion cycles of ICIs fewer than that recommended according to National Comprehensive Cancer Network (NCCN) guidelines as a result of premature termination due to toxicities in the adjuvant setting (yes/no).	Within 1 year after starting ICI treatment
Primary	Incidence of immune-related adverse events (irAEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE)	Rate of grade 2-5 immune-related adverse events (irAEs) will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Racial differences in irAE rates will be assessed in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.	Within 1 year after starting immune checkpoint inhibitor (ICI) treatment
Secondary	Overall response rate (ORR) to immune checkpoint inhibitors (ICIs) assessed by physician report	Overall response rate (ORR) to immune checkpoint inhibitors (ICIs) will be rated by physicians (complete response, partial response, stable disease, unconfirmed/confirmed progression, recurrence). Multivariable modeling will be conducted to adjust for covariates to establish racial differences in ORR.	Within 1 year after starting ICI treatment
Secondary	Health-related quality of life (HRQOL) measured using the PROMIS-Preference (PROPr) summary score	The PROMIS-Preference (PROPr) score is a summary score based on scores for Cognitive Function Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities indices from the PROMIS-29 profile.	Within 1 year after starting ICI treatment
Secondary	Health-related quality of life (HRQOL) measured using the Functional Assessment of Cancer Treatment - Immune Checkpoint Modulation (FACT-ICM)	The Functional Assessment of Cancer Treatment - Immune Checkpoint Modulation (FACT-ICM) contains 25 items. Participants rate severity of ICI-related symptoms on a scale from 0, "not at all," to 4, "very much."	Within 1 year after starting ICI treatment