Actively Recruiting
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
80
Participants Needed
1
Research Sites
437 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. PDS01ADC 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 PDS01ADC 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 PDS01ADC 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 PDS01ADC 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.
CONDITIONS
Official Title
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Biopsy confirmed Kaposi sarcoma requiring systemic therapy
- KS with widespread involvement or causing symptoms affecting quality of life
- KS with inadequate response to prior chemotherapy or immunotherapy, with appropriate washout and resolved toxicity
- At least five measurable cutaneous KS lesions without prior local treatment that would affect assessment
- Measurable disease per AIDS Clinical Trials Group criteria
- HIV positive or negative
- HIV+ participants must be on antiretroviral therapy for 8+ weeks with viral load <400 copies/ml and CD4 count >=50 cells/microliter
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate organ and marrow function including neutrophils >=1,000/mcL, platelets >=100,000/mcL, bilirubin within limits, AST/ALT <=1.5x upper limit
- Hemoglobin >=9 g/dL
- Creatinine normal or creatinine clearance >30 mL/min/1.73m2
- Normal clotting times if receiving M7824
- Women of child-bearing potential and those who can father a child must agree to use contraception and discontinue nursing if treated
- Ability to understand and provide informed consent
You will not qualify if you...
- Receiving any other investigational agents
- Pregnant individuals
- Severe symptomatic pulmonary KS that could be life threatening if progressed over 2-4 weeks
- Active bleeding from visceral KS sites or requiring transfusions within 2 weeks prior to study
- History of bleeding disorders or recent major bleeding events posing high risk
- Active or recent autoimmune disease requiring immunosuppressive treatment (with some exceptions)
- Uncontrolled opportunistic infections
- Active multicentric Castleman disease
- Primary effusion lymphoma
- History of other malignant tumors unless in complete remission for 3+ years or certain skin or cervical lesions
- Allergic reactions to similar compounds as study drugs
- Active tuberculosis under initial treatment or with immune reconstitution syndrome requiring steroids
- Live vaccine within 30 days prior to first study drug dose (except seasonal flu or approved COVID vaccines)
- Uncontrolled serious illnesses limiting study compliance
- Medical, psychiatric, or social conditions precluding study participation or informed consent
- Uncontrolled hepatitis B or C infections
- Prior discontinuation of PD1/PDL1 blockers due to immune side effects or active pneumonitis for combination therapy arm
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
I
Irene B Ekwede, R.N.
CONTACT
R
Ramya M Ramaswami, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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