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NCT04303117 · ClinicalTrials.gov registry record · Phase 1
PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma
A Phase 1 study of Kaposi Sarcoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04303117: Recruiting Phase 1 study of Kaposi Sarcoma, sponsored by National Cancer Institute (NCI).
NCT04303117 is a Phase 1 study of Kaposi Sarcoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 80 participants, below the 96-participant average among 13 other Kaposi Sarcoma trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04303117, a Phase 1 study of Kaposi Sarcoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
The fraction of participants with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.
Conditions Studied
Interventions
- DRUG PDS01ADC
- DRUG M7824
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 1 |
What NCT04303117 shows while recruiting
NCT04303117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 96-participant average among 13 other Kaposi Sarcoma trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Kaposi Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which PDS01ADC is the first listed.
NCT04303117 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04303117 about?
NCT04303117 is a clinical study titled "PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma". 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 he...
What is the current status of trial NCT04303117?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2020-07-13. Estimated completion is 2028-12-01.
What conditions does trial NCT04303117 study?
This clinical trial studies the following conditions: Kaposi Sarcoma.
What interventions are being tested in trial NCT04303117?
The interventions under investigation include: PDS01ADC (DRUG), M7824 (DRUG).
Who is sponsoring clinical trial NCT04303117?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04303117 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04303117's enrollment target sits among peer trials
80 5th of 13 higher than 9 of 13 other Kaposi Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kaposi Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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