240 Participants Needed

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

Recruiting at 598 trial locations
DK
Overseen ByDavid Kozono, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Alliance for Clinical Trials in Oncology
Must be taking: Immuno-oncology therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

DK

David Kozono, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

Received a regimen containing one or more immuno-oncology therapeutics
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
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Sample Collection

Collection of tissue and blood samples at the time of registration and at 1 month after registration

1 month
2 visits (in-person)

Follow-up

Patients' medical records are reviewed for up to 1 year to monitor for immune-related adverse events

12 months

Treatment Details

Interventions

  • Biospecimen Collection
  • Medical Chart Review
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Observational (biospecimen collection, medical record review)Experimental Treatment2 Interventions
Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials
521
Recruited
224,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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