Page 11 - Delaware Medical Journal - January/February 2021

CANCER CLINICAL TRIAL
Alliance A151804: Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
Primary Objectives:
To establish a national biorepository, including biospecimen and clinical data collections from patients treated with IO therapeutics who experience one or more serious (Grade 3–5) irAEs. The irAEs of interest are:
1. Myocarditis 2. Colitis
3. Hepatitis
Eligibility:
4. Nephritis
5. Myositis
6. Pneumonitis
7. Meningitis/Encephalitis 8. Dermatitis
9. Endocrinopathies
10. Neuropathy
11. Rare infections 12. Hyperprogression
• Received one or more immuno-oncology therapeutics. Must have received one or more IO therapeutics.
• Experienced one or more serious AEs.
Must have experienced one or more of the following:
One or more serious (Grade 3–5) AEs that are likely immune-related. AEs included in CTCAE v. 4.03 and/or v. 5.0 that may be immune-related are listed by irAE in Appendix II of the protocol.
Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment.
Hyperprogression, as defined in Appendix III of the protocol. 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.
Patient Participation:
• Grade 3+ irAE Event
• Registration
• Within 1 to 7 days after registration: collection of biospecimens and data
• One month after registration: collection of biospecimens and data
In addition, data will be collected during routine visits until resolution of irAE or until 1 year after the irAE event. Registration must occur within 72 hours of confirmation of irAE event.
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | January/February 2021 | Vol. 93 | No. 1 11