NCT04242095 · Alliance for Clinical Trials in Oncology
Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Anchorage, Alaska
- Fairbanks, Alaska
- Kingman, Arizona
- Phoenix, Arizona
- Fort Smith, Arkansas
- Hot Springs, Arkansas
- Little Rock, Arkansas
- Arroyo Grande, California
- Burbank, California
- Carmichael, California
- Dublin, California
- Elk Grove, California
And 393 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations