M7824 in Subjects With HPV Associated Malignancies
Status:
Active, not recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Background:
In the United States, each year there are more than 30,000 cases of human papillomavirus
(HPV) associated cancers. Some of these cancers are often incurable and are not improved by
standard therapies. Researchers want to see if a new drug M7824, which targets and blocks a
pathway that prevents the immune system from effectively fighting the cancer can shrink
tumors in people with some HPV cancers.
Objectives:
To see if the drug M7824 causes tumors to shrink.
Eligibility:
Adults age 18 and older who have a cancer associated with HPV infection.
Design:
Participants will be screened with medical history and physical exam. They will review their
symptoms and how they perform normal activities. They will have body scans. They will give
blood and urine samples. They will have a sample of their tumor tissue taken if one is not
available.
Participants will have an electrocardiogram to evaluate their heart. Then they will get the
study drug through a thin tube in an arm vein.
Participants will get the drug every 2 weeks for 26 times (1 year). This is 1 course.
After the course, participants will be monitored but will not take the study drug. If their
condition gets worse, they will start another course with the drug. This process can be
repeated as many times as needed.
Treatment will stop if the participant has bad side effects or the drug stops working.
Throughout the study, participants will repeat some or all the screening tests.
After participants stop taking the drug, they will have a follow-up visit and repeat some
screening tests. They will get periodic follow-up phone calls.
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