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NCT02768363 · ClinicalTrials.gov registry record · Phase 2
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
A Phase 2 study of Prostate Cancer, sponsored by Candel Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
- 20
- Study locations
NCT02768363: Active Phase 2 study of Prostate Cancer, sponsored by Candel Therapeutics.
NCT02768363 is a Phase 2 study of Prostate Cancer that is active but no longer recruiting, run by Candel Therapeutics. The registered enrollment target is 187 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02768363, a Phase 2 study of Prostate Cancer, is active but no longer recruiting, sponsored by Candel Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
Primary Outcome
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
Conditions Studied
Interventions
- BIOLOGICAL aglatimagene besadenovec
- BIOLOGICAL placebo
- DRUG valacyclovir
Study Locations (20)
Texas
- San Antonio VA Healthcare System - San Antonio
- Woodland Center - The Woodlands
- Texas Urology Specialists - Tomball
Illinois
- Jesse Brown VA Medical Center - Chicago
- The University of Chicago - Chicago
New York
- Advanced Radiation Centers of New York (Integrated Medical Professionals) - North Hills
- Associated Medical Professionals of NY, PLLC - Syracuse
Oregon
- VA Portland Health Care System - Portland
- Oregon Urology Insitute - Springfield
Pennsylvania
- Lancaster Urology - Lancaster
- Allegheny Health Network-Triangle Urological Group - Pittsburgh
Colorado
- Foothills Urology - Golden
Louisiana
- Southeast Louisiana Veterans Health Care System - New Orleans
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2016-05 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT02768363 still lists
NCT02768363 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which aglatimagene besadenovec is the first listed.
NCT02768363 names 20 study sites across 14 states, led by Texas, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT02768363 about?
NCT02768363 is a clinical study titled "Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)". The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an im...
What is the current status of trial NCT02768363?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2016-05. Estimated completion is 2026-12.
What conditions does trial NCT02768363 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT02768363?
The interventions under investigation include: aglatimagene besadenovec (BIOLOGICAL), placebo (BIOLOGICAL), valacyclovir (DRUG).
Who is sponsoring clinical trial NCT02768363?
This trial is sponsored by Candel Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02768363 being conducted?
This trial has 20 study locations across Colorado, Illinois, Louisiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02768363's enrollment target sits among peer trials
187 238th of 735 higher than 498 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate 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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