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NCT06048484 · ClinicalTrials.gov registry record · Phase 2
Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma
A Phase 2 study of Pancreatic Ductal Adenocarcinoma, sponsored by Gulam Manji.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT06048484: Recruiting Phase 2 study of Pancreatic Ductal Adenocarcinoma, sponsored by Gulam Manji.
NCT06048484 is a Phase 2 study of Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Gulam Manji. The registered enrollment target is 60 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (90% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06048484, a Phase 2 study of Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Gulam Manji.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to combine standard radiation therapy with drugs that encourages the body's immune system against cancer cells and simultaneously adding drugs which also target the pathway that the tumor uses to evade the immune system (CD73 and A2a/b). The study hopes that these drugs will work in concert with radiation therapy to kill cancer cells. The specific goal of this study is to ensure that treatment with zimberelimab and stereotactic body radiation therapy (SBRT) alone or in combination with quemliclustat (a drug which blocks CD73), with or without etrumadenant (a drug which blocks the A2a/b) given before surgery is safe and if it can further increase the immune response against the tumor.
Primary Outcome
The primary endpoint is change in the number of intratumoral CD8+ T-cells at time of surgery between treatment arm(s) compared to the SBRT + zimberelimab arm (Control Arm B). To obtain CD8+ T-cell count, simple immunohistochemistry (IHC) will be used to quantitate CD8+ T-cells. A designated gastrointestinal (GI) pathologist will review each hematoxylin and eosin (H\&E) stained serial section and IHC slide to oversee the process. Representative areas within the slide will be used for cell counts.
Conditions Studied
Interventions
- DRUG Zimberelimab
- DRUG Quemliclustat
- DRUG Modified FOLFIRINOX
- DRUG Etrumadenant
- RADIATION Stereotactic body radiotherapy (SBRT)
Study Locations (5)
New York
- Northwell Health R.J. Zuckerberg Cancer Center - Lake Success
- Columbia University Irving Medical Center - New York
North Carolina
- UNC Hospitals, The University of North Carolina at Chapel Hill - Chapel Hill
Pennsylvania
- University of Pennsylvania, Abramson Cancer Center - Philadelphia
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
What NCT06048484 shows while recruiting
NCT06048484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Zimberelimab is the first listed.
NCT06048484 lists 5 locations in 4 states (New York, North Carolina, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06048484 about?
NCT06048484 is a clinical study titled "Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma". The purpose of this study is to combine standard radiation therapy with drugs that encourages the body's immune system against cancer cells and simultaneously adding drugs which also target the pathway that the tumor uses to evade the immune system (CD73 and A2a/b). The study hopes that these drugs ...
What is the current status of trial NCT06048484?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-05-10. Estimated completion is 2027-04.
What conditions does trial NCT06048484 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT06048484?
The interventions under investigation include: Zimberelimab (DRUG), Quemliclustat (DRUG), Modified FOLFIRINOX (DRUG), Etrumadenant (DRUG), Stereotactic body radiotherapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT06048484?
This trial is sponsored by Gulam Manji, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06048484 being conducted?
This trial has 5 study locations across New York, North Carolina, Pennsylvania, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06048484's enrollment target sits among peer trials
60 52nd of 84 higher than 32 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal Adenocarcinoma 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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