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

Alliance for Clinical Trials in Oncology

Status: Enrolling

Conditions: Malignancy

Treatments: Procedure: Biospecimen Collection; Other: Medical Chart Review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04242095

U10CA180821 (U.S. NIH Grant/Contract)

NCI-2019-07113 (Registry Identifier)

A151804

Details and patient eligibility

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.

Full 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 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.

Enrollment: 240 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

240 participants in 1 patient group

Observational (biospecimen collection, medical record review)

Description:

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.

Treatment:

Other: Medical Chart Review

Procedure: Biospecimen Collection