Clinical trial evaluates COVID-19 vaccine in adults in treatment for cancer

A nurse wearing blue gloves administers a vaccine (vaccination) into a male patient's arm.

Image courtesy of NCI Visuals Online

Adults with hematologic malignancies or solid tumors may be eligible to participate in a new clinical trial at the NIH Clinical Center.

Elad Sharon, M.D., M.P.H., Senior Investigator at the National Cancer Institute, is leading a study to assess the effects of the Moderna COVID-19 vaccine (mRNA-1273) in adults undergoing treatment for various types of cancer.

The study will enroll 120 patients with cancer. One arm of the trial will include 60 patients with solid tumors who are receiving immunotherapy treatments for their cancer. Patients with solid tumors must have started PD-1/PD-L1 inhibitor therapy as part of their care. This is a type of therapy that doesn’t aim to kill cancer cells directly but to block a pathway that shields tumor cells from parts of the immune system that do attack cancer.

The other arm of the trial will enroll 60 adult patients who have blood cancers such as leukemia, lymphoma and multiple myeloma, or who have had a stem cell transplant. Virtually any blood cancer patient may be able to enroll.

The goal is to assess the safety of the Moderna COVID-19 vaccine and its ability to provoke an immune response in adults whose immune systems are suppressed or compromised by their treatments for various types of cancer.

Clinicaltrials.gov identifier:  NCT04847050

NCI Protocol ID:  NCI-00-0-115

Official Title: A Trial of the Safety and Immunogenicity of the COVID-19 Vaccine (mRNA-1273) in Participants With Hematologic Malignancies and Various Regimens of Immunosuppression, and in Participants With Solid Tumors on PD1/PDL1 Inhibitor Therapy

The Center for Cancer Research is NCI’s internal cancer center, a publicly funded organization working to improve the lives of cancer patients by solving important, challenging and neglected problems in cancer research and patient care. Highly trained physician-scientists develop and carry out clinical trials to create the medicines of tomorrow treating patients at the world’s largest dedicated research hospital on the campus of the National Institutes of Health in Bethesda, Maryland.

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Summary Posted: Tue, 04/27/2021