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ACTIVE NOT RECRUITING Phase 2

Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)

NCT02768363 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 187 participants
Start Date 2016-05
Est. Completion 2026-12
Phase Phase 2

Sponsor

Candel Therapeutics

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02768363

The ClinicalTrials.gov registry entry for NCT02768363 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Candel Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02768363 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02768363?

The interventions under investigation include: aglatimagene besadenovec (BIOLOGICAL), placebo (BIOLOGICAL), valacyclovir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02768363?

This trial is sponsored by Candel Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial