PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04303117
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Kaposi Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • PDS01ADC — DRUG
    An initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks and at an MTD dose with M7824 on day 1 of a 28-day cycle.
  • M7824 — DRUG
    1200 mg administered IV every two weeks while on PDS01ADC.

Study Details

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.

Key Dates

Start date
Jul 13, 2020
Status verified
May 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1/Monotherapy
    Treatment with PDS01ADC at de-escalating doses if necessary
  • Experimental: Arm 1a/Monotherapy Expansion
    Treatment with PDS01ADC at MTD
  • Experimental: Arm 2/Combination therapy
    Treatment with PDS01ADC at MTD and M7824 at a fixed dose

Primary Outcome Measure

safety, tolerability and activity of PDS01ADC alone or in combination with M7824 [ Time Frame: 24 cycles of treatment, until confirmed progression, unacceptable toxicity or trial withdrawal ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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