No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
2,240 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Who this trial is looking for
This trial is looking for patients who have experienced side effects from immunotherapy. Participants will provide data and samples to help researchers learn more about these side effects for future studies.
Are You a Good Fit for This Trial?
You may be able to join if
I have received immunotherapy treatment.
I have had serious immune-related side effects.
I have had moderate dermatologic or rheumatologic side effects.
I have been diagnosed with a rare infection after starting immunotherapy.
I have experienced hyperprogression.
I have not previously participated in this study.
You may not be able to join if
I have been diagnosed with COVID-19.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
* 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 b…
* 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 3-54) 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
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