OncoMatch/Clinical Trials/NCT04303117
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
Is NCT04303117 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including PDS01ADC and M7824 for kaposi sarcoma.
Treatment: PDS01ADC · M7824 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Absolute neutrophil count >=1,000/mcL; Platelets >=100,000/mcL; Hemoglobin >= 9g/dL
Kidney function
Creatinine within normal institutional limits OR creatinine clearance >30 mL/min/1.73m^2 as estimated by either Cockroft-Gault or 24-hour urine collection if creatinine levels above institutional normal
Liver function
Total bilirubin within normal institutional limits; OR <3x institutional upper limit of normal (ULN) for Gilbert's syndrome or HIV protease inhibitors; OR <5x ULN and direct bilirubin < 0.7mg/dL for individuals on atazanavir-containing HIV regimen; AST/ALT <=1.5 X institutional ULN
Adequate organ and marrow function as defined below: Absolute neutrophil count >=1,000/mcL; Platelets >=100,000/mcL; Total bilirubin within normal institutional limits; OR <3x institutional upper limit of normal (ULN) for Gilbert's syndrome or HIV protease inhibitors; OR <5x ULN and direct bilirubin < 0.7mg/dL for individuals on atazanavir-containing HIV regimen; AST/ALT <=1.5 X institutional ULN; Hemoglobin >= 9g/dL; Creatinine within normal institutional limits OR creatinine clearance >30 mL/min/1.73m^2 as estimated by either Cockroft-Gault or 24-hour urine collection if creatinine levels above institutional normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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