Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

Recruiting now

Conditions studied: Malignancy

In brief

This trial 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.

Key facts

Study ID

NCT04242095

Run by

Alliance for Clinical Trials in Oncology

People needed

240

Starts

2020-03-12

Expected to finish

2026-10-01

Last updated by the study team

2026-08-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Received a regimen containing one or more immuno-oncology therapeutics
• Must have experienced one or more of the following:
• One or more serious (Grade 3-4) AEs that are likely immune-related
• One or more Grade 2 dermatologic or rheumatologic AEs that are likely 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
• Has not previously been registered to this study

Where it is running

• Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States (enrolling)
• Mercy Hospital Pittsburg — Pittsburg, Kansas, United States (enrolling)
• Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho, United States (enrolling)
• Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States (enrolling)
• Central Care Cancer Center - Great Bend — Great Bend, Kansas, United States (enrolling)
• Veterans Affairs Connecticut Healthcare System-West Haven Campus — West Haven, Connecticut, United States (enrolling)
• Beebe South Coastal Health Campus — Millville, Delaware, United States (enrolling)
• Beebe Health Campus — Rehoboth Beach, Delaware, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States (enrolling)
• Veterans Affairs Loma Linda Healthcare System — Loma Linda, California, United States (enrolling)
• Idaho Urologic Institute-Meridian — Meridian, Idaho, United States (enrolling)
• Central Care Cancer Center - Garden City — Garden City, Kansas, United States (enrolling)
• Washington Health — Fremont, California, United States (enrolling)
• Grand Valley Oncology — Grand Junction, Colorado, United States (enrolling)
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (enrolling)
• Beebe Medical Center — Lewes, Delaware, United States (enrolling)
• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States (enrolling)
• Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States (enrolling)
• Holy Cross Hospital — Fort Lauderdale, Florida, United States (enrolling)
• Saint Helena Hospital — St. Helena, California, United States (enrolling)
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho, United States (enrolling)
• LSU Health Baton Rouge-North Clinic — Baton Rouge, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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