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NCT04390399 · ClinicalTrials.gov registry record · Phase 2
Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study of Pancreatic Cancer, sponsored by ImmunityBio.
- Active
- Registry status
- Phase 2
- Development phase
- 328
- Enrollment target
- 4
- Study locations
NCT04390399: Active Phase 2 study of Pancreatic Cancer, sponsored by ImmunityBio.
NCT04390399 is a Phase 2 study of Pancreatic Cancer that is active but no longer recruiting, run by ImmunityBio. The registered enrollment target is 328 participants, below the 392-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (16% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04390399, a Phase 2 study of Pancreatic Cancer, is active but no longer recruiting, sponsored by ImmunityBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 328 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort.
Primary Outcome
Response Criteria in Solid Tumors (RECIST) V1.1
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- BIOLOGICAL PD-L1 t-haNK
- BIOLOGICAL N-803
- DRUG Aldoxorubicin HCl
Study Locations (4)
California
- Chan Soon-Shiong Institute for Medicine - El Segundo
- Hoag memorial Presbyterian Hospital - Newport Beach
New Jersey
- Astera Cancer Care - East Brunswick
South Dakota
- Avera Cancer Institute - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
What the registry record for NCT04390399 still lists
NCT04390399 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 392-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Gemcitabine is the first listed.
NCT04390399 reports a single indexed study location in California, New Jersey, South Dakota.
Frequently Asked Questions
What is clinical trial NCT04390399 about?
NCT04390399 is a clinical study titled "Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer". This is a phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally adva...
What is the current status of trial NCT04390399?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 328 participants. The study started on 2020-07-21. Estimated completion is 2026-05-31.
What conditions does trial NCT04390399 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT04390399?
The interventions under investigation include: Gemcitabine (DRUG), Nab-paclitaxel (DRUG), PD-L1 t-haNK (BIOLOGICAL), N-803 (BIOLOGICAL), Aldoxorubicin HCl (DRUG).
Who is sponsoring clinical trial NCT04390399?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04390399 being conducted?
This trial has 4 study locations across California, New Jersey, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04390399's enrollment target sits among peer trials
328 47th of 278 higher than 232 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic 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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