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NCT04044859 · ClinicalTrials.gov registry record · Phase 1
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
A Phase 1 study of Ovarian Cancer and Melanoma, sponsored by Uswm CT.
- Active
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 17
- Study locations
NCT04044859: Active Phase 1 study of Ovarian Cancer and Melanoma, sponsored by Uswm CT.
NCT04044859 is a Phase 1 study of Ovarian Cancer and Melanoma that is active but no longer recruiting, run by Uswm CT. The registered enrollment target is 120 participants, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (84% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04044859, a Phase 1 study of Ovarian Cancer and Melanoma, is active but no longer recruiting, sponsored by Uswm CT.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.
Primary Outcome
Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose
Conditions Studied
Interventions
- GENETIC Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks
Study Locations (17)
Other
- Hospital Universitario Vall d'Hebron - Barcelona
- Hospital Universitario Fundacion Jimenez Diaz - Madrid
- Hospital Universitario HM Sanchinarro CIOCC - Madrid
- Hospital Universitario Virgen del Rocio - Seville
Florida
- Name of Institution: Orlando Health Cancer Institute - Orlando
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Washington University - School of Medicine - St Louis
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Duke University Medical Center, Duke Cancer Institute - Durham
Oklahoma
- OU Health Stephenson Cancer Center - Oklahoma City
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-08-20 |
| Est. Completion | 2037-04-30 |
| Phase | Phase 1 |
What the registry record for NCT04044859 still lists
NCT04044859 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (84% lower).
The record links to 9 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks is the first listed.
NCT04044859 lists 17 locations in 14 states (Other, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04044859 about?
NCT04044859 is a clinical study titled "ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)". This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non...
What is the current status of trial NCT04044859?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2019-08-20. Estimated completion is 2037-04-30.
What conditions does trial NCT04044859 study?
This clinical trial studies the following conditions: Ovarian Cancer, Melanoma, Head and Neck Cancer, Endometrial Cancer, Esophageal Cancer.
What interventions are being tested in trial NCT04044859?
The interventions under investigation include: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks (GENETIC).
Who is sponsoring clinical trial NCT04044859?
This trial is sponsored by Uswm CT, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04044859 being conducted?
This trial has 17 study locations across Florida, Massachusetts, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04044859's enrollment target sits among peer trials
120 136th of 322 higher than 186 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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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