PDS01ADC and M7824 for Advanced Kaposi Sarcoma

PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma

Recruiting Phase 1 Phase 2 Interventional Study
Kaposi Sarcoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for

This trial is looking for adults with advanced Kaposi sarcoma that has received other treatments. Participants will receive either PDS01ADC alone or with M7824 and will provide information about their health and KS symptoms throughout the study.

Are You a Good Fit for This Trial?
Must be taking ART
Rules you out Severe KSActive multicentric Castleman diseasePrimary effusion lymphoma

You may be able to join if

  • I am 18 years or older.
  • I have been diagnosed with Kaposi sarcoma.
  • I have received prior chemotherapy or immunotherapy.
  • I have at least five measurable skin lesions.
  • I am able to give informed consent.

You may not be able to join if

  • I am currently pregnant.
  • I have severe Kaposi sarcoma that could become life-threatening.
  • I have active tuberculosis.
  • I have uncontrolled opportunistic infections.
  • I have had major bleeding events in the last 4 weeks.
  • I have an active autoimmune disease.
  • I have received a live vaccine within the last 30 days.
  • I have an uncontrolled HBV infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA: * Individuals with biopsy proven (confirmed in the Laboratory of Pathology \[LP\], CCR) Kaposi sarcoma (KS) * KS requiring systemic therapy, with or without history of prior KS therapy: * T1 KS or T0 KS sufficiently widespread that systemic therapy is advisable, or KS affect…
Contacts

Irene B Ekwede, R.N.

(240) 760-6126

irene.ekwede@nih.gov

CONTACT

Ramya M Ramaswami, M.D.

(240) 506-1088

ramya.ramaswami@nih.gov

CONTACT