To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment (CANINE)

University of Kansas

Status

Active, not recruiting

Conditions

Breast Cancer

Melanoma (Skin)

Lung Cancer

Treatments

Biological: COVID-19 Vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT04821570

IIT-2021-CANINE

Details and patient eligibility

About

This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
Males and females age ≥ 18 years
Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.

Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4

Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
Therapy may be neo/adjuvant or for metastatic disease
Eastern Cooperation Oncology Group (ECOG) Performance status (PS) of 0-2

Exclusion criteria

* Life expectancy of < 12 months