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Collection of Research Data and Samples From Patients Treated With Immunotherapy to Study Its Side Effects

Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04242095
Enrollment
2240
Registered
2020-01-27
Start date
2020-03-12
Completion date
2026-10-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Immune System Disorder, Malignant Solid Neoplasm

Brief summary

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.

Detailed description

PRIMARY OBJECTIVES: To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth). OUTLINE: Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 96 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for 1 year.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of tissue, blood, and stool samples

OTHERMedical Chart Review

Review of medical records

Sponsors

Alliance for Clinical Trials in Oncology
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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 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

Design outcomes

Primary

MeasureTime frameDescription
Establishment of a national biorepository including biospecimen and clinical data collections for future useUp to 1 yearThe objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.

Countries

United States

Contacts

CONTACTDavid Kozono, MD, PhD
dkozono@bwh.harvard.edu617-632-5734
STUDY_CHAIRDavid Kozono, MD, PhD

Brigham and Women's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026