NHS-IL12 Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
Background:
Kaposi sarcoma (KS) tumors grow on the skin, lymph nodes, lungs, bone, and gastrointestinal
tract. KS often affects people with immune deficiencies, such as among people living with HIV
or those with prior history of transplant. Researchers want to see if 2 non-chemotherapy
drugs can help people with KS. NHS-IL12 triggers the immune system to fight tumors. M7824
blocks the pathways that cancer cells use to stop the immune system from fighting tumors.
Objective:
To learn if giving NHS-IL12 alone or with M7824 could help the immune system fight KS tumors.
Eligibility:
People 18 and older with KS that has been treated with chemotherapy or immunotherapy
Design:
Participants will be screened with some or all of the following:
medical history
physical exam
chest X-ray
computed tomography scan
blood and urine tests
electrocardiogram and echocardiogram
skin KS lesion biopsy
lung exam
gastrointestinal exam
All participants will get NHS-IL12 every 4 weeks for up to 96 weeks (or 24cycles). It is
injected under the skin.
Some participants will also get M7824 every 2 weeks for up to 96 weeks (or 24cycles). It is
given through a plastic tube that is put in an arm vein.
Participants will complete questionnaires about how KS affects their quality of life. Their
KS lesions will be measured and photographed. They will repeat some of the screening tests.
They will give saliva samples or additional tissue samples. They will have a lung function
test. Their ability to perform their normal activities will be assessed. The treatment
duration is up to 96 weeks (or 24cycles) with an option to take NHS-IL12 and/or M7824 until
the KS tumors are not responding, or you develop unacceptable side effects.
Participants will have follow-up visits 7 and 30 days after treatment ends, then every 3 to 6
months for the next 18 months, then once a year for 3 years.