Collection of Research Data and Samples from Patients Treated with Immunotherapy to Study Its Side Effects
This study collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.
Eligibility
Inclusion Criterea
- PRE-REGISTRATION ELIGIBILITY CRITERIA: Planning to receive a regimen containing one or more IO therapeutics
- PRE-REGISTRATION ELIGIBILITY CRITERIA: Has not previously been treated with CTLA-4, PD-1 or PD-L1 inhibitors
- PRE-REGISTRATION ELIGIBILITY CRITERIA: Willing and able to provide baseline blood and stool samples
- REGISTRATION ELIGIBILITY CRITERIA: Received a regimen containing one or more immuno-oncology therapeutics
* Must have received one or more IO therapeutics
* In addition to one or more IO therapeutics, patients may also have received other therapeutics such as chemotherapy, hormonal or targeted therapy, as long as these are reported
- REGISTRATION ELIGIBILITY CRITERIA: Must have experienced one or more of the following:
* One or more serious (grade 3–4) AEs that are likely immune-related. AEs included in Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 that may be immune-related
** Patients who experience only hematologic cytopenia(s) who have received cytotoxic therapies, e.g., chemotherapy, within 60 days prior to registration should be excluded
* One or more grade 2 dermatologic, endocrine (except diabetes/hyperglycemia) or rheumatologic AEs that are likely immune-related. AEs included in CTCAE v. 5.0 that may be immune-related
* Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment
** Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded
* Hyperprogression
** Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
- REGISTRATION ELIGIBILITY CRITERIA: Has not previously been registered to this study
* The same patient cannot be enrolled more than once to this study due to development of subsequent irAEs
Participating Clinics
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Kingman Regional Medical Center
Sunrise Hospital and Medical Center
Renown Regional Medical Center
Saint Mary's Regional Medical Center
University Medical Center of Southern Nevada
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Comprehensive Cancer Centers of Nevada - Central Valley
Cancer and Blood Specialists-Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Comprehensive Cancer Centers of Nevada
Radiation Oncology Associates
Radiation Oncology Centers of Nevada Central
Comprehensive Cancer Centers of Nevada - Northwest
Carson Tahoe Regional Medical Center
Comprehensive Cancer Centers of Nevada - Henderson
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
GenesisCare USA - Las Vegas
GenesisCare USA - Henderson
Las Vegas Cancer Center-Henderson
Las Vegas Cancer Center-Medical Center
Radiation Oncology Centers of Nevada Southeast
GenesisCare USA - Fort Apache
GenesisCare USA - Vegas Tenaya
Cancer and Blood Specialists-Shadow
OptumCare Cancer Care at Fort Apache
HealthCare Partners Medical Group Oncology/Hematology-San Martin
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Comprehensive Cancer Centers of Nevada-Summerlin
Summerlin Hospital Medical Center
Cancer and Blood Specialists-Tenaya
Comprehensive Cancer Centers of Nevada-Horizon Ridge
OptumCare Cancer Care at MountainView
Hope Cancer Care of Nevada
OptumCare Cancer Care at Charleston
Hope Cancer Care of Nevada-Pahrump
OptumCare Cancer Care at Seven Hills
Comprehensive Cancer Centers of Nevada - Town Center
Urology Specialists of Nevada - Central
Urology Specialists of Nevada - Green Valley
Las Vegas Urology - Sunset
Las Vegas Urology - Cathedral Rock
Las Vegas Prostate Cancer Center
Urology Specialists of Nevada - Northwest
Las Vegas Urology - Pecos
Las Vegas Urology - Green Valley
Las Vegas Urology - Pebble
Urology Specialists of Nevada - Southwest